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1
Panch, Sandhya R., Yu Ying Yau, Courtney Fitzhugh, Matthew M. Hsieh, John F. Tisdale, Charles D. Bolan, and Susan F. Leitman. "Hematopoietic Progenitor Cell Mobilization In Response To G-CSF Is More Robust In Healthy African American Compared To Caucasian Donors." Blood 122, no. 21 (November 15, 2013): 696. http://dx.doi.org/10.1182/blood.v122.21.696.696.
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Abstract Hematopoietic progenitor cells (HPCs) collected by apheresis of G-CSF-stimulated donors have surpassed bone marrow as the predominant graft source for hematopoietic stem cell transplantation in adults. Among healthy allogeneic donors, demographic characteristics (age, sex, and BMI) and baseline hematologic parameters have been shown to affect HPC mobilization, leading to significant variability in peak levels of CD34 cell egress into the blood and in quantity of CD34 cells harvested by apheresis. Racial differences in G-CSF-mediated HPC mobilization are less well characterized. Benign physiologic neutropenia is common among healthy African Americans (AAs), and may be due to decreased stem cell reserve, fewer G-CSF receptors, or Duffy (null) blood group antigen-mediated decrease in leukocyte trafficking into the circulation. However, preliminary studies have shown relatively robust CD34+ cell mobilization among non-Caucasians given G-CSF (Vasu et al., Blood 2006). We retrospectively analyzed 1,096 consecutive healthy allogeneic related and unrelated first-time donors who self-characterized their race as AA or Caucasian. They underwent G-CSF (filgrastim, Neupogen, Amgen) stimulated HPC collection by leukapheresis from April 1999 to May 2013. G-CSF dose ranged from 10-16 mcg/kg, given daily for 5 days. An unstimulated leukapheresis procedure for lymphocyte collection was performed in the 7 days preceding G-CSF in 336 subjects. Apheresis procedures were performed on the CS-3000 Plus or COBE Spectra device. Baseline lab data included CBC, serologic blood group antigen typing, and Hb electrophoresis in AA donors. CD34+ cell counts were performed on peripheral blood immediately pre-apheresis (2 hours after the 5th dose of G-CSF) and on the apheresis product. Values are given as mean ± SD. All AA (n=215) and Caucasian donors (n=881) with complete data sets were included. Sex ratio was similar among the groups (45 vs 52% male; p=0.09). AAs were younger (39 vs 43 yrs, p=0.001) and had greater weight (86 vs 81 kg, p=0.001) and BMI (30 vs 27; p<0.0001) than Caucasians. G-CSF dose/kg was similar in the 2 groups, but total daily dose of G-CSF was greater in AAs than Caucasians (920 vs 850 mcg, p<0.0001). After adjusting for age, sex, height, weight, and total daily G-CSF dose, peak CD34+ cell mobilization immediately pre-apheresis was higher among AAs than Caucasians (123 ± 87 vs 75 ± 47 cells/uL; p<0.0001) (Figure). When laboratory parameters such as baseline WBC, MNC, and platelet counts were included in the stepwise regression model, AA race remained a significant predictor of higher peak CD34 cell counts. At higher G-CSF doses (16 mcg/kg/d), the difference in mobilization responses between the 2 groups was less apparent (peak CD34 counts 123 vs 93 cells/uL, AA (n=33) vs Caucasian (n=73), p=0.07) than at lower doses (10 mcg/kg/d), where peak CD34 counts were 123 vs 74 cells/uL, AA (n=182) vs Caucasian (n=808), p<0.0001. AAs had lower baseline ANC (3.4 vs 4.0 x 103 cells/uL, p<0.001) than Caucasians, but demonstrated significantly higher peak WBC and MNC counts after G-CSF. In AA donors with known HbS status, presence of sickle cell trait had no effect on CD34 mobilization (peak CD34 counts 123 ± 91 vs 107 ± 72 cells/uL, HbAS (n=41) vs HbAA (n=84), p=0.34). Similarly, in AA donors with known Duffy phenotype, Duffy expression did not affect CD34 mobilization (peak CD34 counts 114 ± 81 vs 134 ± 85 cells/uL, Fya-b- (n=49) vs Fya+ &/Fyb+ (n=20), p=0.4). Lymph-apheresis prior to starting G-CSF was associated with significantly improved CD34+ cell mobilization; however the effect did not differ by race. CD34 apheresis yield was also greater in AAs than Caucasians (51 ± 35 vs 32 ± 21 x 106 cells per liter processed, p <0.0001), consistent with higher pre-apheresis counts. African Americans demonstrated significantly more robust CD34 mobilization responses to G-CSF than Caucasians. The effect was independent of age, BMI, HbS and other variables, and occurred despite physiologically lower neutrophil counts among AAs. A ceiling effect in response to increased doses of G-CSF (>10 mcg/kg) was seen in AAs but not in Caucasians, suggesting that dose titration based on race might be used to optimize HPC yields. Further evaluation of race-associated genetic polymorphisms in relation to G-CSF pharmacokinetics may help improve G-CSF dosing strategies. Disclosures: No relevant conflicts of interest to declare.
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Badar, Talha, Hagop M. Kantarjian, Farhad Ravandi, Elias Jabbour, Gautam Borthakur, Jorge E. Cortes, Naveen Pemmaraju, Sherry R. Pierce, Naval Daver, and Srdan Verstovsek. "Therapeutic Benefit of Decitabine, a Hypomethylating Agent, in Patients with Myeloproliferative Neoplasm in Blastic Phase/Acute Myeloid Leukemia (MPN-AML), Accelerated Phase (MPN-AP), and DIPSS-Plus High Risk Primary Myelofibrosis (PMF)." Blood 124, no. 21 (December 6, 2014): 3186. http://dx.doi.org/10.1182/blood.v124.21.3186.3186.
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Abstract Background: MPN-AML, MPN-AP, and DIPSS-plus high risk PMF are associated with a poor response to therapy and shortened survival. Several studies have shown clinical activity of hypomethylating agents (DNA methyltransferase inhibitors) in these situations. We reviewed our database to evaluate the clinical outcome of patients (pts) with MPN-AML, MPN-AP and DIPSS-plus high risk PMF who received decitabine (DAC; a hypomethylating agent) in the course of their treatment at our institution. Methods: Retrospective chart review identified 21 pts with MPN-AML, 13 with MPN-AP and 11 with DIPSS-plus high risk PMF treated with DAC in our center over last 7 years. MPN- AP was defined by 10%-19% blasts in the peripheral blood or bone marrow (BM). DIPSS-plus is a prognostic model for PMF and can be applied at any point during the disease course (Gagnat et al. J Clin Oncol 2011; 29:392-7). Responses in MPN-AML were defined according to published recommendations (Mascarenhas et al. Leuk Res 2012; 36:1500-4). Responses in MPN-AP and DIPSS-plus high risk PMF were defined according to the revised IWG-MRT and ELN consensus report (Tefferi et al. Blood 2013; 122: 1395-8). Results: MPN-AML pts characteristics: median age 64 yrs (range, 45-82); initial MPN: ET 4 (19%), PV 5 (24%), PMF 10 (48%), and MPN unclassified 2 (10%) pts. The median number (no.) of prior therapies for MPN was 1 (range, 0-4). The median time for transformation from MPN to MPN-AML was 93 mo (range, 1.4-292). Thirteen (39%) pts had unfavorable cytogenetics. DAC was given as first-line therapy in 12 (57%) pts, as second-line therapy in 8 (38%), and as third-line in 1 (5%). The median no. of DAC cycles given was 2 (range, 1-15). MPN-AP pts characteristics: median age 63 yrs (range, 50-81); initial MPN: ET 2 pts (15%), PV 5 (39%), and PMF 6 (46%). The median no. of prior therapies for MPN was 2 (range, 0-5). The median time from diagnosis of MPN to DAC was 65 (0-389) mo. The median no. of DAC cycles given was 2 (range 1-37). PMF with DIPSS-plus high risk pts characteristics: median age 67 yrs (range, 55-77). Seven (64%) pts had a JAK2 mutation. The median hemoglobin (Hb) was 9.2 g/dl (range, 7.7-11.7), median WBC was 41.5 K/uL (range, 2-140), median platelet (plt) count was 69 K/uL (range, 9-860) and bone marrow blast percentage (BM BL %) was 2% (range, 0-9). The median number of DIPSS-plus risk factors was 6 (range, 4-8), and median no. of prior therapies was 1 (range, 0-4). The median time to DAC from diagnosis of PMF was 19 (3-195) mo. The median no. of DAC cycles given was 3 (range 1-8). Six (29%) MPN-AML pts responded to DAC: 3 CR, 2 CRi and 1 PR. Two pts who achieved CR, received DAC as second line after falling induction chemotherapy for AML. The median time to response was 2.6 mo (range, 1-13.5). Among non-responders; 10(48%) pts died due to disease progression, 3 (14%) pts died due to sepsis, one is alive with stable disease (SD) on therapy, and one pt died 2 months after bone marrow transplant (BMT). The median response duration (defined as time to next therapy/death/last follow up) was 7 mo (range, 2-24). One patient responding to DAC had BMT after 2 months of maintaining the response. The median OS from the time of post MPN-AML acquisition was 6.9 mo. The OS was 10.5 mo in responders vs 4 mo in non-responders (p= 0.024) (Fig. 1A). Among MPN-AP, 1 pt had clinical improvement (CI) in Hb and plt, and 7 had SD (with improvements in blood count), for overall benefit in 8 (61%) pts. The median benefit duration was 6.5 mo. (1.8-14). Four (31%) pts with SD after improvement in leukocytosis and BM BL % had BMT. The median OS from the time of MPN-AP acquisition was 9.7 mo. The OS in responders was 11.8 mo. vs 4 mo. in non-responders (p=0.28) (Fig.1B). Among non-responders 3 (23%) pts transformed to AML, one pt received next line of therapy and had BMT, one pt died due to disease progression. Nine (82%) pts with DIPSS-plus high risk PMF benefited from DAC: 1 had CI in plt, 1 had CI in spleen, and 7 had SD (with improvements in blood count). Median response duration was 9 mo (1-23). Three (27%) pts had BMT after improvement in leukocytosis and BM BL %. Both pts who did not respond, progressed to AML and died due to infectious complication. The median OS was 36.6 mo: OS in responders was 190 mo vs 4.7 mo in non-responders (p=0.027) (Fig. 1C). Conclusion: DAC is a viable therapeutic option for pts with MPN-AML, MP-AP and high-risk PMF. Prospective clinical studies combining DAC with other clinically active agents are needed to improve overall outcome. Figure 1 Figure 1. Disclosures No relevant conflicts of interest to declare.
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Mawardi, Mawardi. "PEMBERLAKUAN KURIKULUM SD/MI TAHUN 2013 DAN IMPLIKASINYA TERHADAP UPAYA MEMPERBAIKI PROSES PEMBELAJARAN MELALUI PTK." Scholaria : Jurnal Pendidikan dan Kebudayaan 4, no. 3 (September 3, 2014): 107. http://dx.doi.org/10.24246/j.scholaria.2014.v4.i3.p107-121.
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<p>Konsekuensi utama pemberlakuan kurikulum 2013 untuk jenjang SD/MI diantaranya pada cara mensinergikan pendekatan, model dan standar proses pembelajaran, serta cara menyusun dan melakukan penilaian. Dua komponen utama sistem pembelajaran ini merupakan komponen yang sangat erat kaitannya dengan peningkatan mutu pembelajaran. Pendekatan, model dan standar proses pembelajaran berkaitan dengan jaminan mutu prosesnya, sedangkan komponen penilaian berkaitan dengan akurasi dan validitas pengukuran mutu pembelajaran tersebut. Pendekatan saintifik (5M) yang meliputi keterampilan proses mengamati, menanya, mengumpulkan informasi, mengasosiasi dan mengkomunikasikan perlu disinergikan dengan standar proses eksplorasi, elaborasi, dan konfirmasi (EEK). Kedua keterampilan (5M dan EK) inilah yang menjadi pemandu bagi guru untuk memilih model (dan metode) pembelajaran serta alat penilaian otentik yang sesuai. Dalam rangka membantu para guru untuk mengimplemantasikan kurikulum 2013, Kementerian Pendidikan dan Kebudayaan menyiapkan buku guru dan buku siswa. Namun demikian para guru dapat memodifikasi dan mengembangkan sendiri. Pengembangan instrumen pembelajaran disesuaikan dengan karakteristik para siswa dan lingkungan belajar-nya, sehingga mutu proses dan hasil pembelajaran dapat ditingkatkan. Pengem-bangan mutu pembelajaran seperti ini sekaligus menjadi sarana bagi para guru untuk mengembangkan profesinya secara berkelanjutan. Permasalahannya adalah pemberlakuan kurikulum 2013 berimplikasi pada proses pengembangan keprofesian guru, misalnya bagaimana proses pelaksanaan penelitian tindakan kelas (PTK) yang selama ini telah dilakukan. Rambu-rambu pendekatan, model, sistem penilaian, buku guru dan buku siswa dalam kurikukum 2013 mestinya tidak membatasi ruang gerak guru dalam berinovasi. </p>
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Hermansen, Erland, Ivar Magne Austevoll, Christian Hellum, Kjersti Storheim, Tor Åge Myklebust, Jørn Aaen, Hasan Banitalebi, et al. "Comparable increases in dural sac area after three different posterior decompression techniques for lumbar spinal stenosis: radiological results from a randomized controlled trial in the NORDSTEN study." European Spine Journal 29, no. 9 (June 18, 2020): 2254–61. http://dx.doi.org/10.1007/s00586-020-06499-0.
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Abstract Purpose To investigate changes in dural sac area after three different posterior decompression techniques in patients undergoing surgery for lumbar spinal stenosis. Summary of background data Decompression of the nerve roots is the main surgical treatment for lumbar spinal stenosis. The aim of this study was to radiologically investigate three commonly used posterior decompression techniques. Methods The present study reports data from one of two multicenter randomized trials included in the NORDSTEN study. In the present trial, involving 437 patients undergoing surgery, we report radiological results after three different midline retaining posterior decompression techniques: unilateral laminotomy with crossover (UL) (n = 146), bilateral laminotomy (BL) (n = 142) and spinous process osteotomy (SPO) (n = 149). MRI was performed before and three months after surgery. The increase in dural sac area and Schizas grade at the most stenotic level was evaluated. Three different predefined surgical indicators of substantial decompression were used: (1) postoperative dural sac area of > 100 mm2, (2) increase in the dural sac area of at least 50% and (3) postoperative Schizas grade A or B. Results No differences between the three surgical groups were found in the mean increase in dural sac area. Mean values were 66.0 (SD 41.5) mm2 in the UL-group, 71.9 (SD 37.1) mm2 in the BL-group and 68.1 (SD 41.0) mm2 in the SPO-group (p = 0.49). No differences in the three predefined surgical outcomes between the three groups were found. Conclusion For patients with lumbar spinal stenosis, the three different surgical techniques provided the same increase in dural sac area. Clinical trial registration The study is registered at ClinicalTrials.gov reference on November 22th 2013 under the identifier NCT02007083.
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Meier, Emily R., Ross M. Fasano, Monica Estrada, Jianping He, Robert Mccarter, and Naomi L. C. Luban. "Reticulocytosis and Anemia in Early Infancy Is Associated with Abnormal and Conditional Transcranial Doppler Velocities in Pediatric Sickle Cell Anemia Patients." Blood 124, no. 21 (December 6, 2014): 4080. http://dx.doi.org/10.1182/blood.v124.21.4080.4080.
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Abstract All sickle cell anemia patients (HbSS, SCA) have the same genetic mutation, but the clinical phenotype is highly variable and difficult to predict prior to the onset of complications. Transcranial Doppler (TCD) is the only validated predictive indicator of severe SCA currently available, identifying SCA patients age 2 years or older with the greatest stroke risk. Preliminary studies have identified that elevated absolute reticulocyte count (ARC) between 2 and 6 months of age is associated with an increased risk of hospitalization for SCA complications, stroke and death.1,2 To determine if early reticulocyte levels in SCA patients are useful in classifying children at highest risk of developing an abnormal (abTCD) or conditional (cdTCD) TCD, 121 consecutive patients with SCA who had TCD screening were identified after IRB review granted a waiver of consent. Retrospective chart review was then performed to collect the steady state ARC between 2 and 6 months of age; patients were excluded if this value was not available in the medical record. Steady state was defined as a sample collected at least 30 days from an acute illness and at least 60 days since the patient received a blood transfusion. ARC and hematologic data were analyzed using Cox regression analysis to determine the relationship between ARC levels and time to cdTCD/abTCD. TCDs were considered normal (nlTCD) if the Time Average Mean Maximum Velocity (TAMMV) in the middle cerebral artery or distal internal carotid artery was <170 cm/sec, cdTCD if TAMMV was 170-199 cm/sec and abTCD if TAMMV was 200 cm/sec or greater. To evaluate the utility of ARC or hemoglobin in risk stratification, patients were divided into groups: ARC less than 200K/uL (ARC<200) and ARC greater than or equal to 200K/uL (ARC≥200), or hemoglobin less than 8.5 g/dL (Hb<8.5) and hemoglobin greater than or equal to 8.5 g/dL (Hb≥8.5). Twenty of the 121 (16.5%) patients had abTCD, while 36/121 (29.8%) had cdTCD; the remaining 65/121 (53.7%) had nlTCDs. Mean ARC between 2 and 6 months of age was highest in those children with abTCDs (264±149 K/uL) and cdTCDs (175±76 K/uL) while those who had nlTCDs had the lowest values (mean ARC 140±100K/uL, p<0.001 across groups). Mean hemoglobin was lower in the abTCD (8.1±1.2 g/dL) and cdTCD groups (8.9±1.1 g/dL) compared to the nlTCD group (9.5±1.5 g/dL, p<0.001). The three groups did not differ in age at time of ARC measurement [mean age in months: 3.6±1.2 (nlTCD) vs. 3.8±1.3 (cdTCD) vs. 3.4±1.0 (abTCD), p=0.86]. Kaplan Meier analysis revealed that those children with higher ARC had an increased rate of cdTCD/abTCD (p<0.001 by the log-rank test). Lower hemoglobin was also associated with an increased rate of cdTCD/abTCD (p=0.002). Cox regression analysis revealed that those subjects with an ARC≥200 between the ages of 2 and 6 months had 2.9 times the risk of having an abTCD or cdTCD than the group with an ARC<200 (HR 2.92, 95% CI 1.68-5.08, p=0.0004). In separate analyses, patients with a hemoglobin less than 8.5 g/dL had 2.4 [95%CI 1.38-4.06 (p=0.002)] times the risk of having an abTCD/cdTCD than patients with a hemoglobin level of 8.5 g/dL or greater. These data suggest that both elevated ARC and low baseline hemoglobin during early infancy are associated with an increased risk of developing a cdTCD or abTCD later in childhood. ARC and hemoglobin at this early age should be prospectively studied as standard screening tests to assist with treatment decisions in young children with SCA. Meier ER, Byrnes C, Lee YT, et al. Increased reticulocytosis during infancy is associated with increased hospitalizations in sickle cell anemia patients during the first three years of life. PLoS One 2013; 8(8):e70794. doi: 10.1371/journal.pone.0070794.Meier ER, Wright EC, Miller JL. Reticulocytosis and anemia are associated with an increased risk of death and stroke in the newborn cohort of the Cooperative Study of Sickle Cell Disease. Am J Hematol 2014 May 31; doi: 10.1002/ajh.23777. [Epub ahead of print] Disclosures No relevant conflicts of interest to declare.
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Luskin, Marlise R., Phyllis A. Gimotty, Gerald Wertheim, Catherine Smith, Alison R. Sehgal, Selina M. Luger, Stephen R. Master, Alison W. Loren, and Martin P. Carroll. "A Measure of DNA Methylation for Predicting Outcome in De Novo AML." Blood 124, no. 21 (December 6, 2014): 2345. http://dx.doi.org/10.1182/blood.v124.21.2345.2345.
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Abstract Background: Accurate prediction of response to induction chemotherapy and survival is essential for improving care of AML patients. Established prognostic schemes in AML are based on 1) clinical features and 2) pre-treatment karyotype. More recently molecular markers have been shown to be of prognostic importance. Correlation between DNA methylation in leukemic cells and clinical prognosis has been described but is not assessed routinely in clinical practice due to lack of a clinical assay. Here we report the ability of a novel, clinically feasible assay of DNA methylation status to predict clinical outcomes in AML patients. Methods: A novel microsphere-based assay for multiplex evaluation of DNA methylation (xMELP) was used to simultaneously measure methylation status at multiple prognostic loci in banked AML samples. A methylation risk score (M score) was assigned to each sample using a 17-locus random forest classifier developed using an independent cohort. Cytogenetic risk was assigned to each sample using the MRC schema (Grimwade et al. Blood 2010). The primary clinical endpoints were failure to achieve complete remission (CR) within 90 days of induction and death before 2-years (2-year death). The receiver operating characteristic (ROC) curve was used to evaluate the performance of the M-score as prognostic biomarker. Univariate and multivariate logistic models were used to assess the ability of the M-score to predict 2-year death in combination with co-variates. Results: This study included 101 patients with de novo AML age < 60 years with diagnostic samples available for xMELP analysis who underwent induction therapy at the University of Pennsylvania (2001-2012). The median age was 48 years (range 19-59), the median WBC count at diagnosis was 34.5 K/uL (range .8 -283.5 K/uL; 20% ≥100K/uL), and 55% were male. The majority of patients had intermediate cytogenetic risk (13% favorable, 65% intermediate, 18% unfavorable, 4% unknown). Among the study patients, 25% did not achieve CR and 52% died within 2 years of diagnosis. The mean M-scores for the entire population were 84.6 (SD 30.3) versus 104.9 (SD 29.3) for those who achieved and failed to achieve CR, respectively (p=.004) while the mean M-scores were 77.5 (SD 24.7) versus 100.5 (SD 32.7) for those alive and dead at 2 years, respectively (p=.002). Within the intermediate cytogenetic risk group, results were similar: the mean M-scores were 87.3 (SD 31.8) versus 105.1 (SD 29.6) for those who achieved and failed to achieve CR, respectively (p=.06) and the mean M-scores were 78.9 (SD 25) versus 101.2 (SD 33.9) for those alive and dead at 2 years, respectively (p=.004). The M-score was not associated with sex or WBC at diagnosis, but it differed significantly among the 4 cytogenetic risk groups (ANOVA p=.01) with a higher M-score in less favorable cytogenetic groups. The area under the ROC curve (AUC) was .69 for failure to achieve CR (95% CI .58-.80) and .71 (95% CI .61-.81) for 2-year death. For AML patients with intermediate cytogenetic risk, the AUC was .66 (95% CI .52-.80) for failure to achieve CR and .70 (95% CI .57 to .82) for 2-year death. For the cohort overall, the odds ratios for failure to achieve CR and 2-year death were 1.02 (p=.007) and 1.03 (p=.001), respectively, indicating that every 1-point rise in the M-score resulted in a 2% higher chance of not achieving CR and a 3% greater chance of dying by 2 years. We investigated the ability of the M-score to predict 2-year death in combination with other prognostic co-variates. Adding age, diagnostic WBC count, and cytogenetic risk to the prognostic model did not improve prediction of 2-year death. A model incorporating M-score and CR did predict 2-year death better than M-score alone (AUC .80 versus AUC .71, p=.005). Results were similar when restricting analysis to intermediate cytogenetic risk group (AUC .77 versus AUC .70, p=.048). Conclusion: There is a clinical need for predictive biomarkers in AML. Here, we show that a novel method of measuring methylation in AML predicts failure to achieve CR and likelihood of death within 2 years. A model incorporating methylation and remission status was better for prediction of 2-year death than a model with only methylation information. Although validation in additional cohorts is necessary, these results demonstrate the feasibility and benefit of clinical application of a multiplex DNA methylation assay to survival prognostication in AML. Disclosures No relevant conflicts of interest to declare.
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Cunniffe, Brian, Carissa Fallan, Adora Yau, Gethin H. Evans, and Marco Cardinale. "Assessment of Physical Demands and Fluid Balance in Elite Female Handball Players During a 6-Day Competitive Tournament." International Journal of Sport Nutrition and Exercise Metabolism 25, no. 1 (February 2015): 78–96. http://dx.doi.org/10.1123/ijsnem.2013-0210.
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Little data exists on drinking behavior, sweat loss, and exercise intensity across a competitive handball tournament in elite female athletes. Heart rate (HR), fluid balance and sweat electrolyte content were assessed on 17 international players across a 6-day tournament involving 5 games and 2 training sessions played indoors (23 ± 2 °C, 30 ± 2% relative humidity). Active play (effective) mean HR was 155 ± 14 bpm (80 ± 7.5% HRmax) with the majority of time (64%) spent exercising at intensities >80% HRmax. Mean (SD) sweat rates during games were 1.02 ± 0.07 L · h-1 and on 56% of occasions fluid intake matched or exceeded sweat loss. A significant relationship was observed between estimated sweat loss and fluid intake during exercise (r2 = .121, p = .001). Mean sweat sodium concentration was 38 ± 10 mmol · L-1, with significant associations observed between player sweat rates and time spent exercising at intensities >90% HRmax (r2 = .181, p = .001). Fluid and electrolyte loss appear to be work rate dependent in elite female handball players, whom appear well capable of replacing fluids lost within a tournament environment. Due to large between-athlete variations, a targeted approach may be warranted for certain players only.
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Amaru, Ricardo, Ariel Amaru, Hortensia Miguez, Torres Gina, Josue Mamani, Oscar Vera, Heriberto Cuevas, Josef T. Prchal, and Jaroslav F. Prchal. "Bolivian Aymara Natives with Chronic Mountain Sickness Have Autonomous BFU-E Growth." Blood 126, no. 23 (December 3, 2015): 5206. http://dx.doi.org/10.1182/blood.v126.23.5206.5206.
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Abstract Background Erythrocytosis / polycythemia is divided into primary and secondary. Primary polycythemia can be either acquired; i.e. polycythemia vera (PV) due to somatic JAK2 mutation, or congenital due to germ-line DNA changes (erythropoietin (EPO) receptor and VHL mutations in Chuvash polycythemia). These mutations are expressed within erythroid progenitors, drive increased erythropoiesis and are detected by hypersensitive or autonomous EPO BFU-E responses. In contrast, secondary erythrocytosis (SE), such as seen with cardiopulmonary pathologies, is driven by the circulating EPO. Chronic mountain sickness (CMS) is characterized by high altitude pathological erythrocytosis and by cognitive and neurological impairments. CMS is found in subjects living in high altitude (2500 meters and higher). In La Paz, Bolivia, (3600m) there is 7% incidence of CMS erythrocytosis. Some human populations (Tibetans, Andean Quechuas and Aymaras, and Ethiopians) are adapted to very high altitudes and their adapted phenotypes and, in some instances, evolutionarily selected haplotypes, have been reported. Whole genome was evaluated in Andeans and two genes, SENP1 and ANP32D were found to be evolutionarily selected and correlated with presence or absence of erythrocytosis. The genes down-regulation in hypoxia had survival benefit in Drosophila ortholog (1).SENP1 desumoylate GATA-1 and other regulatory proteins and is critical for definitive erythropoiesis (2,3). Here we evaluated native Aymara La Paz dwellers with three types of polycythemia: CMS, SE secondary to cardiopulmonary disease, and PV, by clinical studies and by in vitro evaluation of erythroid progenitors, and compared them to non-polycythemic subjects. Patients and Methods Complete blood count was performed by automatic hematologic counter (Micro 60, USA). Serum EPO was measured by Elisa (R&D System, USA) and JAK2V617F mutation analysis by PCR assay. Erythroid progenitors were isolated by density gradient centrifugation and cultured in methylcellulose medium with and without EPO (Stem Cell technologies, Canada) at 370 C and 5 % CO2. BFU-E colonies reading was carried out according to standardized criteria at 7 and 14 days. Results Table. Normal Control(n=10) CMS (n=15) Secondary Erythrocytosis(n=10) PolycythemiaVera (n=5) 1.Gender M/F 10/0 15/0 10/0 3/2 Age (range) 42 (40-47) 48 (29-58) 53 (34-72) 67 (42-74) Hb g/dl (SD) 16.2 (+ 0.9) 20.3 (+ 0.9) 22.8 (+ 1.4) 20.0 (+ 2.5) Ret % (SD) 1.3 (+ 0.1) 2.9 (+ 1.3) 3.6 (+ 1.2) 2.1 (+ 0.3) WBC /ul (SD) 6300 (+ 1600) 7200 (+ 1900) 6600 (+ 1700) 16600 (+ 4800) PLT 103 ul (SD) 273 (+ 80) 229 (+ 58) 193 (+ 54) 604 (+ 177) sEPO mUI/ml (SD) 10.0 (+ 3.9) 10.5 (+ 2.2) 82.9 (+ 30.4) 3.0 (+ 1.2) JAK2 V617F, No. (%) 0 (0) 0 (0) 0 (0) 100 Apoptosis Normal Delayed Normal Delayed BFU-E: EEC 0 (0-0) 10 (2-25) 0 (0-0) 45 (25-70) References: 1. Yu L et al. J Exp Med., 2010, 207:1183. 2. Sharma D et al. Cell Report, 2013, 3:1640. 3. Zhou D et al. Am J Hum Genet. 2013, 93:452. 4. Kapralova K et al. Blood. 2014,123:391 Conclusions a) Endogenous erythroid colony (EEC) are present in Aymaras with CMS, indicating primary polycythemia. b) Endogenous EECs are higher in PV than in CMS. c) CMS subjects have normal serum EPO levels. d) The role of SENP1, and hypoxia-regulated RUNX1 and NF-E2 (4) that promote erythropoiesis, is being interrogated in native erythroid cells. e) It remains to be determined if the autonomous BFU-E growth is specific for Aymara's CMS or present in CMS individuals of other ethnicities. Disclosures No relevant conflicts of interest to declare.
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Arnedos, Monica, Crystal Shereen Denlinger, Wael A. Harb, Olivier Rixe, John Charles Morris, Grace K. Dy, Alex A. Adjei, et al. "A phase I study of MM-121 in combination with multiple anticancer therapies in patients with advanced solid tumors." Journal of Clinical Oncology 31, no. 15_suppl (May 20, 2013): 2609. http://dx.doi.org/10.1200/jco.2013.31.15_suppl.2609.
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2609 Background: MM-121 is a fully human monoclonal antibody targeting the epidermal growth factor receptor family member ErbB3. ErbB3 has been implicated in driving cancer growth and in the development of resistance to conventional chemotherapies across multiple malignancies. Here we present results of an open-label, Phase 1, multicenter, non-randomized, dose-escalation trial which recently completed enrollment evaluating MM-121 in combination with one of the following chemotherapies: Gemcitabine (Arm A, n=11), carboplatin (Arm B, n=11), pemetrexed (Arm C, n=10), or cabazitaxel (Arm D, n=11). Methods: Patients were treated in a dose escalation “3+3” design to assess the safety, tolerability and pharmacokinetics (PK) of MM-121 administered weekly in combination with anticancer therapies in subjects with advanced cancer. Doses were escalated until the maximum tolerated dose (MTD) was identified or the combination was shown to be tolerable at the highest planned doses. Secondary objectives included: Determining the objective response rate, clinical benefit rate, PK and immunogenicity of MM-121. Data summarized are as of 1/17/2013 from a live database. Results: Overall, 43 patients, [22 (51%) female and 21 (49%) male] have been treated with a median treatment duration of 57 days (range 1-302). The median age was 59 years (range 42-84) and patients had received a median of four prior lines of therapy (range 0-13). Common (>20%) adverse events of any grade and causality across all arms included diarrhea (74%), nausea (54%), fatigue (51%), anemia (44%), vomiting (33%), hypokalemia (30%), decreased appetite (26%), thrombocytopenia (26%), peripheral edema (23%), neutropenia (21%), and constipation (21%). Four DLTs were observed: Two in combination with carboplatin (G4 thrombocytopenia and G3 rash), one with gemcitabine (G4 thrombocytopenia), and one with pemetrexed (G4 hyperuricemia). Overall 38 (88%) patients were evaluable for response and the overall clinical benefit rate (PR or SD >18 weeks), is 32% (12/38). Conclusions: MM-121 can be combined at its recommended single agent dose with standard doses of gemcitabine, pemetrexed, and cabazitaxel and adapted doses of carboplatin. Clinical trial information: NCT01447225.
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Roe, Christa, Jennifer Rock-Klotz, Elyce Turba, Christopher Rodriguez Salamanca, Janice Bennett, Farrah Farquharson, Sem Bastien, et al. "Sézary Syndrome: Clinicopathological and Immunophenotypical Characteristics and Outcomes." Blood 126, no. 23 (December 3, 2015): 1546. http://dx.doi.org/10.1182/blood.v126.23.1546.1546.
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Abstract Background Sézary syndrome (SS) is a rare malignant T-cell lymphoproliferative disorder derived from mature CD4+ T-helper/inducer cells. Patients (pts) with SS usually manifest with generalized erythroderma, peripheral blood and lymph node involvement and severe pruritus. Current therapy usually consists of extracorporeal photopheresis, interferon alpha, alemtuzumab, histone deactylase inhibitors (HDACi) and monochemotherapy. SS is considered incurable with conventional skin directed or conventional systemic therapy. Reports in literature suggest overall survival (OS) between 2-5 years. Methods Between 2002 and 2015, 50 pts with SS were evaluated and treated at Moffitt Cancer Center (MCC). Patient demographics, disease/treatment characteristics, responses, and outcomes were collected from our CTCL database. We characterized four groups based on immunophenotype, aberrant loss of CD26 and CD7, or both. Responses to treatment were assessed using standard criteria: complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD). Descriptive statistics were used to report baseline characteristics. Chi square and t-test were used for comparison of categorical and continuous variables respectively. Kaplan-Meier graphs were used for estimation of OS from time of diagnosis. Results We identified 50 patients with SS with median follow-up of 52 months. Median age was 70 years. Male to female ratio was 1.6:1. Most pts were Caucasians (88%),). A majority of patients (76%) had advanced stage disease (IVA+IVB). Measurable adenopathy was identified in 35 pts (70%). Median number of Sezary cell count in peripheral blood was 1,747/ul. Extracorporeal Photopheresis (ECP) was used in 43 pts (86%). Overall response rate (ORR) after 6 months of therapy was the following: CR 3(6%), PR 9 (18%), SD 7 (14%), PD 24 (48%). The only agents with activity achieving were interferon (ORR 6%, CR 2%), alemtuzumab (ORR 8%, CR6%), MTX (ORR 6%, CR 2%), and bexarotene (ORR10%, CR 2%), Responses to HDAC inhibitors were: romidepsin (ORR 6%, all PR) and vorinostat (ORR 4%, CR 2%). Median OS was 96 months (95% CI 70-121). Based on aberrant immunophenotype patterns, pts were stratified into 4 groups: 1) CD4+CD7+CD26- 26% (13), 2) CD4 + CD 7- CD26+ in 12% (6), 3) CD4+ CD7- CD26- in 34% (17) and 4) CD4+ CD7+ CD26+ in 24% (12). The median OS for CD4+ CD 7- CD26- was 84 months versus not reached (NR) for other groups. This difference was statistically significant when groups 3 and 2 (p <0.05), and groups 3 and 4 (p< 0.02) were compared. However, there was only a trend observed when groups 3 and 2 were compared (p=0.3). The median OS was 86 month if absolute Sezary cell count was >1700/ul compared to 96 mo if < 1700/ul (P< 0.4). Conclusions Pts with SS in this study showed an improved survival compared to historical studies. Advent of ECP, novel targeted agents such as HDACi inhibitors and monoclonal antibodies, earlier diagnosis, and better supportive care have most probably contributed to this phenomenon; except ECP, CR rates were very rare. A majority of the pts require multimodality induction therapy followed by maintenance therapy. Pts with Sezary cell immunophenotype characterized by aberrant loss of both CD26 and CD7 antigens had worse outcome. There was also a tendency for worse OS in pts with higher circulating absolute Sezary cell count. Disclosures Komrokji: Celgene: Consultancy, Research Funding; Incyte: Consultancy; Novartis: Research Funding, Speakers Bureau; Pharmacylics: Speakers Bureau. Sokol:Seatle Genetics: Research Funding; Celgene: Consultancy; Spectrum: Consultancy.
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Jacobson, Karen, and Onyema Ogbuagu. "Comparison of Time to Viral Suppression Among Treatment-Naïve HIV-Infected Adults Initiating Combination Antiretroviral Therapy by Antiretroviral Regimen Class." Open Forum Infectious Diseases 4, suppl_1 (2017): S432. http://dx.doi.org/10.1093/ofid/ofx163.1090.
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Abstract Background Antiretroviral therapy (ART) regimens for the treatment of HIV that incorporate the integrase strand inhibitor (INSTI) class of antiretroviral medications have high efficacy and tolerability, and may result in faster time to virologic suppression compared with regimens that contain protease inhibitors (PIs) or non-nucleoside reverse transcriptase inhibitors (NNRTIs). However, differences in viral suppression are not well-defined in routine clinical settings. Methods We performed a retrospective single-center chart review of treatment-naïve HIV patients initiating ART between 2013 and 2016. Among patients on different ART regimen types, we compared rates of achievement of viral suppression (defined as viral load less than limit of detection or <20 copies/uL) over time and median time to viral suppression using chi-square and independent samples median testing. Patients who were prescribed nonstandard regimens, were nonadherent, or discontinued or changed ART within 6 months were excluded. Results One hundred and fifty-five patients—45 (29.0%) female and 110 (71%) male—met study inclusion criteria. Mean age at ART initiation was 41.3 years (SD 12.5), and mean baseline viral load was 293,974 copies/uL. Twelve (7.7%) patients had an opportunistic infection diagnosed at time of ART initiation. Seventy-one (45.8%) initiated an INSTI-based ART regimen, 58 (37.4%) initiated a NNRTI-based regimen, and 26 (16.8%) initiated a PI-based regimen. Eighty-one (52.3%) patients had documented viral suppression, with median time to viral suppression 105 days (IQR 49–159). Patients on INSTI regimens were more likely to achieve viral suppression by 6 months (93.2% compared with 69.7% on NNRTIs and 30.8% on PIs), and had lower median time to suppression (62.6 days vs. 140.5 days on NNRTI regimens and 154.5 days on PI regimens, P = 0.002). Conclusion In this cohort, patients on INSTI-based ART regimens experienced higher rates of viral suppression at 6 months and shorter time from ART initiation to viral suppression. In HIV patients on INSTI-based ART regimens, virologic failure should be suspected prior to the current recommendation of 6 months. Disclosures All authors: No reported disclosures.
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Chen, Bao-An, Jie Xiong, Long Ba, Feng Gao, Chong Gao, Jia-Hua Ding, Yun-Yu Sun, et al. "Identification of Transcription Factor AP-1 Bound to Untranslated 5′ Regulatory Region DNA of mdr1 Gene with Atomic Force Microscopy." Blood 108, no. 11 (November 16, 2006): 4195. http://dx.doi.org/10.1182/blood.v108.11.4195.4195.
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Abstract Multidrug resistance(MDR) phenotype of cancer cells is a major obstacle for cancer chemotherapy, this phenotype is main due to the overexprssion of the mdr1 gene. Transcription factor AP-1, which is one of important regulate proteins in the promoter region of mdr1 gene. To date, no direct data of AP-1-DNA regulating complexes on mdr1 gene. A novel method for identifying DNA-binding proteins from image analysis using atomic force microscopy(AFM) was developed. This study is to image and map the structure of Untranslated 5′ regulatory region DNA of mdr1gene, identificate and analysis of transcription factor AP-1 bound to Untranslated 5′ regulatory region DNA of mdr1 gene complex with atomic force microscopy, to find out the molecule mechanism of multidrug resistance. Human leukemia adriamycin resistant strain K562/A02 was used as a target cells, transcription factor AP-1 was used as a target protein. Cultivate and PCR technique was used to amplify K562/A02 cells with the 769bp 5′regulatory region DNA of mdr1 gene, which fragment from −755 to +14. The amplified DNA products were purified by the PCR product purification kit, AP-1 of hela nuclear extract were purified by Sephadex spin-column filled with a bed of Sephadex G-100. The target DNA fragments were incubated with the target protein AP-1 at a 1:2 molar ratio in binding buffer and then immobilized the the AP-1-DNA complexes on a freshly cleaved mica surface which treated by MgCl2. AFM was used to idificate image of the structure of target DNA and the AP-1-DNA complexes. We show here the applicability of AFM in the quantitative analysis of the molecular mechanisms of DNA-protein interaction: The optimum DNA concentration to yield well-absorbed DNA molecular on the mica surface was found to be 10ng/ul. the contour of target DNA AFM image :the length of the DNA fragment measured by AFM image was 260.13± 2.29nm, the width was 11.88 ± 0.92nm, the mean height was 1.2nm(mean±SD, N = 50). Sephadex spin-column (Ultrafree- MC 0.22) can be used to purificate DNA and protein-DNA complex, the contour data of AP-1 protein AFM image:: the width of proteinlarge was 30±3.2nm, protein small was 19±2.8nm; the height of proteinlarge was 3.8±1.4nm, proteinsmall was 3.2±1.8nm (mean±SD, N = 30). we got the contour data of pro- tein-DNA complexes: the width of protein large was 28±2.7nm, the height was 3.4± 0.94nm (mean±SD, N = 8), the width of proteinsmall was 18±1.7nm, the height was 3.1±2.2nm (mean±SD, N = 22), and deduced the possible AP-1 site on mdr1DNA located between bases −126 and −115bp, this result is in close agreement with the expected −121 and −115 bp values. the overall connection efficiency of protein was about 10%. The AFM method to visualize individual biomolecules allows us to investigate the conformation of protein-DNA complexes.
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Schneider, Larissa S. A., Rogério F. Daher, Bruna R. S. Menezes, Rafael S. Freitas, Liliane B. Sousa, Verônica B. Silva, Eduardo P. Furlani, and Ana K. F. Vidal. "Selection of Elephant-Grass Genotypes for Forage Production." Journal of Agricultural Science 10, no. 12 (November 15, 2018): 148. http://dx.doi.org/10.5539/jas.v10n12p148.
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The objective of this study was to evaluate the agronomic traits of 80 accessions of elephant grass under the soil and weather conditions of Campos dos Goytacazes/RJ, Brazil. The experimental design was set as randomized blocks with 2 replicates. The experiment continued from March 2012 to May 2013, with 5 harvests made in the dry and rainy seasons. The following traits were assessed: percentage of dry matter (%DM), dry matter yield (DMY), number of tillers per meter (NT), plant height (HGT), stem diameter (SD), leaf blade width (LBW) and leaf blade length (LBL). Data from each harvest were subjected to analysis of variance and to the Scott-Knott test (P < 0.05). Tocher’s optimization method, Mahalanobis distance, and canonical variables were utilized for the multiple traits, and the importance of the characters in the canonical variables. Genotypes with high yield were Elefante da Colômbia, Taiwan A-25, Albano, Hib. Gigante da Colômbia, Elefante de Pinda, Taiwan A-121, P241 Piracicaba, Guaçu/I.Z.2, CPAC, EMPASC 309, EMPASC 307, Australiano, and Pasto Panamá. Stem diameter (rainy season) and LBW (dry season) were the most important variables to differentiate between genotypes. There was wide phenotypic variation between genotypes, which could be divided into 15 groups by Tocher’s optimization method.
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Der, E. M., F. Sutaa, T. B. Azongo, and C. Kubio. "Stillbirths at the West Gonja hospital in northern Ghana." Journal of Medical and Biomedical Sciences 5, no. 1 (May 30, 2016): 1–7. http://dx.doi.org/10.4314/jmbs.v5i1.1.
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In most parts of Ghana, stillbirths (SBs) do not count in routine mortality data collection and there-fore are not seen as a major public health problem. The aim of this study was to determine still-birth rate, trend, causes and factors associated with stillbirth at the West Gonja Hospital in northern Ghana and offer recommendations. This study reviewed antenatal cards of mothers and records in the labour and maternity wards for cases of SBs from January 2009 to December 2013 for foetal and maternal characteristics. Data were entered and analyzed using SPSS software (version 18, Chicago). There were 3,641 births and 121 SBs during the study period with an average SBs rate of 33.2 per 1000 births. There was a gradual rise in the annual incidence of SBs from 2.9% in 2009 to 3.9% in 2012. Majority (55.4%) of the SBs were fresh. A total of 58 (47. 9%) of the SBs had no identifiable cause. The mean gestational age of SBs was 34.8 weeks (SD=4.2), and the mean weight was 2.4 Kg (SD=0.8). Majority (73.9%) of the mothers were housewives. We found strong positive associations between SBs and maternal occupation (p<0.00), but negatives associations with maturity of pregnancy (p= 0.01), mode of delivery (p<0.00), type of pregnancy (p=0.04) and the causes of stillbirths (p<0.00). This study found a high SBs rate of 33.2 per 1000 births, with a gradual rise in the incidence over the study period. Many of the SBs had no identifiable cause. Most of the mothers who had stillbirths were house wives and many of the cases had no identifiable causes. There is the need for improve SBs data collection and the need for further investigations on the causes of stillbirth in Ghana.Journal of Medical and Biomedical Sciences (2016) 5(1), 1-7Keywords: Mortality data, causes, incidence rate, parity, gestational week
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Viswabandya, Auro, P. V. Prashanthi, C. Nirmala Raju, Reena Rajsekhar, Vikram Mathews, Shivkumar Madki, Dhiraj Abhayankar, et al. "Pharmacokinetic and Pharmacodynamic Evaluation of a Biosimilar Rituximab in Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL) Treated with R-CHOP (Rituximab, Cyclophosphamide, Adriamycin, Vincristine, Prednisolone)." Blood 110, no. 11 (November 16, 2007): 4491. http://dx.doi.org/10.1182/blood.v110.11.4491.4491.
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Abstract Addition of rituximab (375 mg/m2) to CHOP has been shown to improve survival in patients with DLBCL. However there is limited data on the pharmacokinetics (PK) and pharmacodynamics (PD) of this drug in this condition. We have evaluated the PK and PD of a biosimilar rituximab (Reditux®, Dr. Reddy’s Laboratories Ltd, Hyderabad, India) in 17 patients with newly diagnosed DLBCL treated at a single center with R-CHOP as part of a multi-center study undertaken to assess the safety and efficacy of this drug. R-CHOP (rituximab-375mg/m2; cyclophopsphamide-750mg/m2; adriamycin-50mg/m2; vincristine-1.4mg/m2 on day 1 and prednisolone-60mg/m2 on days 1 to 5) was given every 3 weeks for a total of 6 cycles. Blood samples for measurement of rituximab were collected just prior to start of infusion and 10min, 24, 72, 192 and 360 hours post-infusion for all patients during cycle 1 and in 6 patients during cycle 6 also. Additional samples were collected pre- and 10 minutes post-infusion after cycles 2, 3, 4, 5 and 6. Plasma rituximab levels were quantified using an immunoassay (sensitivity: 1ug/ml). B-lymphocyte counts were measured in peripheral blood samples taken from all patients at the beginning of each cycle. All patients were evaluated for clinical and radiological response after the 2nd, 4th and 6th cycles. Patients, mean age: 52 years (range:31–71) had disease in the following stages: stage II: 5, stage III: 7, stage IV: 5. Twelve out of 17 patients achieved complete remission while 5 had partial response (NCI criteria). At a mean follow-up of 5 months (range: 3–8), 3 patients had relapse of the disease. The arithmetic mean ±SD of PK parameters of Rituximab during cycle 1 were as follows: T½(hrs): 167±63; Cmax(ug/ml): 186±49; Cmin(ug/ml): 22.4±12.84; AUC0-∞ (ug.hrs/ml): 28162±11227) and Cl/F (ml/kg/hr): 23.8±10.8. These data are comparable with values previously reported for rituximab in other conditions. Though a 2–7 fold inter-individual variation was noted among these patients, there was no significant difference in these parameters between those in whom the disease relapsed as opposed to those who maintained remission. Among the 6 patients in whom data was available for the 1st and 6th cycles (table), there was significant reduction in Cl/F with associated increase in Cmax and AUC in the 6th cycle as compared to the 1st cycle. In 16 patients for whom the data was available, pre-treatment mean B lymphocyte count which was 121/ul (range:1.5–410.5) dropped to a mean of 9.9/ul (range:0.3–62.3) after the first cycle and remained in that range for the rest of treatment period. These data show that even with a 3-weekly regimen, therapeutic trough levels (25 μg/ml) of rituximab was observed across all cycles. In fact, the changing PK parameters of the drug with progressive cycles of R-CHOP suggest that fixed-dose regimens may not be the optimal way to administer this drug. Parameter Cycle1 (n=6) Cycle 6 (n=6) p value T ½ (hours) 200 386 0.0481 Cmax (μg/ml) 203 279 0.0556 Cmin (360Hr) 24.71 82.16 0.0028 AUC0- ∞ (μg.hrs/ml) 31167 92240 0.0049 Cl/F(ml/kg/hr) 20.5 7.6 0.0030
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Shahid, Muhmmad Jameel, Faheem Ahmad, Muhammad Asif, and Muhmmad Nabeel Sultan. "VISUAL OUTCOME IN DIABETIC MACULAR EDEMA AFTER GRID LASER TREATMENT." Professional Medical Journal 23, no. 04 (April 10, 2016): 478–83. http://dx.doi.org/10.29309/tpmj/2016.23.04.1516.
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Regarding the causes of blindness, Diabetic retinopathy is a one the majorcause of blindness in all types persons from both industrialized and developing countries.Due to inadequate eating habits, prevalence of diabetic retinopathy is increasing. Both focaland diffuse leakage from retinal capillaries can cause Diabetic macular edema. Varioustreatment modalities for macular photocoagulation are focal laser, Grid laser and modified gridused in patients having diabetic macular edema Study Design: Prospective, interventional,noncompetitive case series. Setting: Department of Ophthalmology, Allied Hospital andDepartment of Ophthalmology, Divisional Headquarter Hospital Faisalabad. Period: One yearfrom April 2012 to April 2013. Materials and Methods: A total of 200 eyes of 200 patientswith clinical significant macular edema that met the inclusion criteria were enrolled. Results: Inthis study, 200 patients with diabetic macular edema were studied. Of these 121 (60.5%) weremales and 79 (39.5%) females with mean age of 38.52 years (SD 7.512, Range 25-50 years).All patients had diffuse, clinically significant macular edema at baseline for which they hadreceived grid laser photocoagulation. Discussion: In recent past number of diabetic patientsall over the world has increased that has caused increase incident of diabetic retinopathy .Soin patients having diabetic retinopathy, macular edema can cause deterioration in visual acuityduring any stage of diabetic retinopathy. The pathogenesis of Diabetic macular edema (DME)is the disruption of inner blood – retinal barrier that is known to be associated with metabolicalteration affecting the retinal pigment epithelium or retinal vascular endothelium. Focal and/orgrid laser photocoagulation is being considered as the treatment of DME. Conclusion: Macularphotocoagulation was found to be an effective method of treatment for CSME among diabeticpatients, which has resulted in a positive visual outcome in 87% of the patients (stable andimproved vision).
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Akingbola, Titilola S., Bamidele Tayo, Santosh L. Saraf, Binal N. Shah, Chinedu A. Ezekekwu, Omowunmi Sonubi, Lewis L. Hsu, Richard S. Cooper, and Victor R. Gordeuk. "Low Fixed Dose Hydroxyurea for the Treatment of Adults with Sickle Cell Disease in Nigeria." Blood 130, Suppl_1 (December 7, 2017): 981. http://dx.doi.org/10.1182/blood.v130.suppl_1.981.981.
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Abstract Background: The vast majority of births with sickle cell anemia occur in Africa 1 and early-life mortality, generally before age five years, is as high as 90% 2,3. Hydroxyurea was approved for sickle cell anemia by the US FDA in 1998 but is not commonly used in Africa due to fear of toxicity, lack of awareness and limited availability. Hemoglobin F is a protective factor that decreases severity of sickle cell anemia, and hydroxyurea treatment leads to an increase in hemoglobin F. In the US, hydroxyurea is typically initiated at a dose of 15 mg/kg followed by dose escalations of up to 35 mg/kg if tolerated with a goal of maximal tolerated dose and maximal response in hemoglobin F. Neutropenia and thrombocytopenia are the usual limitations to achieving maximal dose. In the landmark Multicenter Study of Hydroxyurea, the clinical response to hydroxyurea correlated strongly with a reduction in the neutrophil count as well as an increase in the fetal hemoglobin concentration as reflected in percentage of F cells. A striking decrease in pain crises was observed in the first three months of therapy, before dose escalation and before maximal increase in hemoglobin F levels 4. Furthermore, hydroxyurea in the range of 10-15.9 mg/kg/day was reportedly effective in decreasing the frequency of pain episodes in children and adolescents in Oman 5, and hydroxyurea 10 mg/kg/day decreased pain episodes in children and adults with sickle cell anemia in India 6. From these perspectives, we reasoned that a fixed dose of hydroxyurea 10 mg/kg/day is reasonable to investigate in the African setting where the safety in relationship to the resources and infectious exposures is not known. Methods: We assigned 48 sickle cell anemia patients to hydroxyurea 500 mg/day for 24 weeks to determine safety and efficacy; 28 had high-risk disease based on hemoglobin F<8.6% and absence of alpha-thalassemia. We defined a clinically meaningful adverse outcome category as ≥10% of patients developing platelets <50,000/uL, granulocytes <500/uL, clinical malaria and/or active tuberculosis. Picking up refills every four weeks was the adherence metric. We analyzed the results on an intent-to-treat basis. Results: The median (interquartile range) age was 25 (22-27) years and the median hydroxyurea dose 9.8 (9.1-10.4) mg/kg per day. The patients complied with treatment for a median of 20 (16-24) weeks. Four (8.3%) developed a pre-specified adverse outcome: clinical malaria (N=2), thrombocytopenia in combination with malaria (N=1), pulmonary tuberculosis (N=1). During therapy the median hemoglobin increased by 9.0 g/L, mean corpuscular volume by 11.2 fL and body weight by 3.0 kg while median white blood cells declined by 2600 per uL and platelets by 127,000 per uL (P<0.001). The median hemoglobin F increased from 4.1% (2.3-6.3%) at baseline (N=27) to 8.5% (6.3-12.9%) during therapy (N=24) (P<0.001). Conclusion: Our results suggest that low, fixed-dose dose hydroxyurea for sickle cell anemia in Nigeria is associated with a low adverse outcome rate and with improvements in blood counts, hemoglobin F and body weight. The effects on vaso-occlusive episodes and on the risks of recrudescent tuberculosis and malaria-associated thrombocytopenia should be assessed in further studies. Acknowledgment: Supported by a grant from the Doris Duke Foundation. References 1. Williams TN, Obaro SK. Sickle cell disease and malaria morbidity: a tale with two tails. Trends Parasitol 2011;27:315-20. 2. Grosse SD, Odame I, Atrash HK, Amendah DD, Piel FB, Williams TN. Sickle cell disease in Africa: a neglected cause of early childhood mortality. Am J Prev Med 2011;41:S398-405. 3. Makani J, Cox SE, Soka D, et al. Mortality in sickle cell anemia in Africa: a prospective cohort study in Tanzania. PLoS One 2011;6:e14699. 4. Charache S, Barton FB, Moore RD, et al. Hydroxyurea and sickle cell anemia. Clinical utility of a myelosuppressive "switching" agent. The Multicenter Study of Hydroxyurea in Sickle Cell Anemia. Medicine (Baltimore) 1996;75:300-26. 5. Sharef SW, Al-Hajri M, Beshlawi I, et al. Optimizing Hydroxyurea use in children with sickle cell disease: low dose regimen is effective. Eur J Haematol 2013. 6. Patel DK, Mashon RS, Patel S, Das BS, Purohit P, Bishwal SC. Low dose hydroxyurea is effective in reducing the incidence of painful crisis and frequency of blood transfusion in sickle cell anemia patients from eastern India. Hemoglobin 2012;36:409-20. Disclosures Ezekekwu: American Society of Hematology: Other: The Visitor training program was sponsored by ASH. Hsu: AstraZeneca steering committee for HESTIA trial: Research Funding. Gordeuk: Emmaus Life Sciences: Consultancy.
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Ghosh, Nilanjan, Lakshmi Rudraraju, Xiaobu Ye, Kimberly Noonan, Carol Ann Huff, and Ivan M. Borrello. "Administration Of An Oral PDE5 Inhibitor, Tadalafil In Conjunction With a Lenalidomide Containing Regimen In Patients With Multiple Myeloma." Blood 122, no. 21 (November 15, 2013): 1959. http://dx.doi.org/10.1182/blood.v122.21.1959.1959.
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Abstract Increasing tumor burden has been associated with an immunosuppressive network posing a significant barrier to anti-tumor immunity. Amongst these pathways, myeloid derived suppressor cells (MDSCs) play a critical role in suppressing immune function through upregulation of iNOS and arginase-1 (Arg1). There is evidence of increased MDSCs in patients with multiple myeloma compared to healthy donors [1]. Additionally, it has been shown that MDSCs regulate the growth of myeloma by inhibiting T cells in the bone marrow [2]. We therefore hypothesized that inhibiting MDSCs could augment the anti-tumor activity of the immunomodulatory drug lenalidomide. We have shown previously that phosphodiesterase 5 inhibitors such as tadalafil effectively inhibit MDSC function through downregulation of iNOS and Arg-1 production [3]. To prospectively study the effect of MDSC inhibition in myeloma, we initiated a clinical trial in patients who were refractory to lenalidomide-based regimens, with the oral PDE5 inhibitor, tadalafil, added to their lenalidomide-containing regimen. Refractory to lenalidomide containing regimen was defined as disease progression within 60 days of lenalidomide/dexamethasone (Rd) or Biaxin/lenalidomide/dexamethasone (BiRd). Responses were monitored by International Myeloma Working Group (IMWG) criteria. 13 patients were enrolled between April 2012 and March 2013. Median age was 63, 46.1% female, median number of prior therapies was 4 (range 3-10), 10 patients (80%) had BiRd as their immediate prior therapy, 3 (20%) patients had Rd as the immediate prior therapy, 4 (30.8%) patients had high risk cytogenetics/FISH, 4 (30.8%) patients had ISS III disease and 5 (38.4%) patients had a stem cell transplant in the past. 2 patients were not evaluable, 1 did not meet the eligibility criteria and another patient with a history of gastrointestinal (GI) bleed came off protocol in less than a week because of a recurrent GI bleed. 1 (9%) patient had a minor response (MR) lasting 3 months, 4 (36.4%) patients achieved stable disease (SD), 6 (54.5%) patients developed progressive disease (PD). For patients who achieved SD, the median duration was 66 days (range 48-161 days). Median PFS was 48 days (95% CI 25-71 days). 2 (18.1%) patients needed dose reduction of tadalafil for grade 3 back pain, which was the only toxicity attributable to the drug. There were no deaths on study. At a median follow up of 1 year, the OS is 81.8%. The trial met early stopping rule due to lack of response. Biologic correlates were performed pre and post treatment and included measurement of MDSCs numbers by flow cytometry using CD14+, CD33+, HLADRlow, IL4Rα+ or CD15+, CD33+, HLADRlow, IL4Rα+. Interestingly, MDSCs were not detected in any of the patients at baseline in both blood and marrow and this correlated with the lack of clinical response. In mice, lenalidomide can reduce MDSC numbers [4]. All patients on this trial were heavily pre-treated with lenalidomide for a median duration of 783 days (range 55-1741 days) which could explain the low numbers of MDSCs at enrollment. Strategies aimed at inhibiting MDSC function would be best tested in patients who have elevated levels of MDSCs by flow cytometry. References 1. Gorgun, G.T., et al., Tumor-promoting immune-suppressive myeloid-derived suppressor cells in the multiple myeloma microenvironment in humans. Blood, 2013. 121(15): p. 2975-87. 2. Ramachandran, I.R., et al., Myeloid-derived suppressor cells regulate growth of multiple myeloma by inhibiting T cells in bone marrow. J Immunol, 2013. 190(7): p. 3815-23. 3. Serafini, P., et al., Phosphodiesterase-5 inhibition augments endogenous antitumor immunity by reducing myeloid-derived suppressor cell function. J Exp Med, 2006. 203(12): p. 2691-702. 4. Sakamaki, I., et al., Lenalidomide enhances the protective effect of a therapeutic vaccine and reverses immune suppression in mice bearing established lymphomas. Leukemia, 2013. Disclosures: Off Label Use: Tadalafil for supression of myeloid derived suppressor cells.
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Alharbi, Reem, Mahmoud Aljurf, Raid El Fakih, Mohammad Al Nahedh, Majed Huessein, Zubeir Ahmed Nurgat, Almohareb Fahad, et al. "The Impact of Early Post-Transplant Cyclosporine Induced Acute Nephrotoxicity on Long Term Renal Function in 2-Year Survivors of Allogeneic Hematopoietic Stem Cell Transplantation: A Cohort Retrospective Study." Blood 132, Supplement 1 (November 29, 2018): 3358. http://dx.doi.org/10.1182/blood-2018-99-114667.
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Abstract Introduction:Acute kidney injury (AKI) and chronic kidney disease (CKD) affect 10-70% of transplant recipients. Onset of kidney injury varies from days to months or years after transplantation. Kidney injury may be caused by multiple factors. Long-term data on cyclosporine induced nephrotoxicity post HSCT are limited. It is unclear if cyclosporine induced nephrotoxicity at early phase post HSCT will impact long term renal function. The objective of this study is to evaluate the progression of renal function in allogeneic hematopoietic stem cell transplant (HSCT) patients, before, during and after cyclosporine therapy. Methods:This is a retrospective single arm cohort study evaluating the impact of cyclosporine on renal function in patients who underwent allogeneic HSCT from 2003 through 2013. Patients age≥ 14 years who underwent allogeneic HSCT and received cyclosporine as graft-versus-host disease (GVHD) prophylaxis and alive two years post HSCT without disease relapse or GVHD were included in the study. Primary outcome was the change in serum creatinine and estimated creatinine clearance. Delta creatinine (baseline creatinine - creatinine on day 25, day 100, day 180, year 1 and year 2 post HSCT) was used to calculate the change in the serum creatinine and estimated creatinine clearance. Estimated creatinine clearance was calculated using Cockcroft and Gault formula (CG) for patients aged ≥ 18 years. Schwartz formula was used to estimate creatinine clearance for patients aged ≥ 14 years till 18 years. The secondary outcome was the incidence of acute kidney injury. AKI was defined as per RIFLE criteria. The severity grades were defined on the basis of the changes in serum creatinine. CKD was defined if estimated glomerular filtration rate (GFR) <60 ml/minute per 1.73 m2 for 3 months. All patient during the study period were screened. Descriptive statistics were used to describe the data, continuous variables were reported as mean ± stander deviation and categorical variables were summarized as frequencies and percentages. The study was approved by the Office of Research Affairs in our institution. Results: Out of 912 patients who underwent allogeneic HSCT from 2003 to 2013, 121 patients were included who met the inclusion criteria listed above in the method section (Figure 1). The majority of patients were males (55%) with sever aplastic anemia as primary disease (31%). Mean baseline serum creatinine was 52±16 µmol/l, mean baseline estimated creatinine clearance was 116±58 ml/minute per 1.73 m2 (Table 1). Mean duration of cyclosporine levels monitoring was 232±180 days. Serum creatinine increased from the baseline at day 25, day 100, day 180, 1 year and 2 years post HSCT (Mean± SD; 45.7 ±39, 66.2 ±45.9, 37.8±27.1, 31.9±22.55, 28±22.5 µmol/l, respectively) (Figure 2). This translated into reductions in the estimated creatinine clearance at day 25, day 100, day 180, 1 year and 2 years post HSCT (Mean± SD; -61.6±51 , -89.6 ±55.7,-67. ±55.34,-62.5±55.4,-57.6±56.ml/minute per 1.73 m2, respectively) (Figure 3). The highest incidence of AKI was at day 100 post HSCT in the included patients. 40% of them had supratherapeutic cyclosporine levels. There was association between developing acute kidney injury at day 100 and CKD at 2 years post HSCT, 23% of the included patients had acute kidney injury and 13 % of them found to have CKD at 2 years post HSCT as illustrated table 2. Conclusion:Our study demonstrated that cyclosporine represents a primary risk factor for progression of renal impairment in hematopoietic stem cell transplant recipients particularly in those who developed acute kindly injury at 100 days. Disclosures No relevant conflicts of interest to declare.
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McKiernan, Phyllis, David H. Vesole, David S. Siegel, Scott D. Rowley, Melissa F. Baker, Brenda Diaz, Themba Nyirenda, Joshua R. Richter, Pamela Sutherland, and Michele L. Donato. "Haploidentical Allogeneic Transplantation As Salvage in Relapsed Multiple Myeloma." Blood 124, no. 21 (December 6, 2014): 5918. http://dx.doi.org/10.1182/blood.v124.21.5918.5918.
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Abstract Allogeneic stem cell transplantation (SCT) using HLA-haploidentical (HAPLO) related donors has been an effective strategy for treating hematologic malignancies in patients who lack a matched donor. In multiple myeloma (MM), allogeneic SCT used in tandem or as salvage therapy can be a potentially curative option, however, there is little data regarding the use of HAPLO donors in this population. We report 10 patients with MM who received HAPLO allografts between 2011-2014. Median age was 53 (range 28-61) and 5 patients were male. All patients, except one, were relapsed or refractory to at least 1 prior autograft. Patients with pre-transplant CD4 counts >200/uL received a fludarabine (Flu)-based regimen for in-vivo lymphodepletion to prevent graft rejection. Conditioning regimen for transplantation was Flu 30 mg/m2 daily x5 with cyclophosphamide (Cy) 14.5 mg/kg daily x 2, followed by TBI 200-400 cGY in 1 or 2 fractions. Post-transplant immunosuppression consisted of Cy 50-60 mg/kg on days +3 and +4, followed by tacrolimus and mycophenolate starting on day +5. All patients received filgrastim starting on day +5. Six patients received bone marrow (BM) with a median cell dose of 2.76 x 10e6 CD34cells/kg (range 1.1-4.02) and 4 patients received peripheral blood stem cells (PBSC) with a median cell dose 4.01 x 10e6 CD34 cells/kg (range 1.05-4.04). One patient developed sepsis on day +14 and died on day +31 without hematologic recovery. All other patients achieved engraftment, with median neutrophil engraftment of 18 days (range 14-45) and median platelet engraftment of 21 days (range 14-53). There was no difference between engraftment for BM or PBSC. Median time to neutrophil engraftment was 17 days for BM and 19.5 days for PBSC (p=ns). Median time to platelet engraftment was 29 days for BM and 20.5 days for PBSC(p=ns). Median time to full donor chimerism was 32 days overall (range 27-61); 38 days for BM (range 29-61) and 27.5 days for PBSC (range 27-32). At a median follow up of 10 months (range 1-35), 6 patients are alive. Of those, 2 patients are in CR, 3 in VGPR, and 1 with stable disease (SD). The 2 year overall survival is 46%. The causes of death for 4 patients were sepsis (1), progressive disease (2), and chronic inflammatory demyelinating polyneuropathy (CIDP) (1). Eight patients developed acute graft versus host disease (GVHD), with one having grade III, and 7 with grade I-II. Five patients were treated for chronic GVHD, 3 mild and 2 moderate by NIH criteria. None of the deceased patients developed chronic GHVD and all of the surviving patients had chronic GVHD, except for 1 who is prior to day +100 at the time of this report. Four patients were treated for grade 3 infections, with 1 infection-related death. Five patients relapsed or progressed their disease after HAPLO transplant, with a median time to progression of 7.8 months (range 3.2-11.4). Of these, 1 is in VGPR after salvage therapy, 1 has SD after salvage therapy and donor lymphocyte infusion, 2 died from relapse and 1died from CIDP. KIR typing was available for 8 recipient and donor pairs. There were 2 KIR B/x to A/A transplants, with1 patient deceased and 1 alive. All of the 4 KIR B/x to B/x recipients are alive, and the 2 KIR A/A to B/x recipients are deceased. This small series suggests HAPLO transplantation can be used in patients with advanced MM who are without a suitable matched donor. Our patients achieved timely hematologic engraftment and donor chimerism with BM or PBSC. There was no fatal acute GVHD, and as previously reported, chronic GVHD may be protective against relapse. Further studies need to be done to further elucidate the impact of KIR typing on transplant outcomes. Overall Survival Figure 1 Figure 1. Disclosures No relevant conflicts of interest to declare.
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Fredslund-Andersen, S., P. Lage-Hansen, N. Svendsen, M. Jeppesen Rechnagel, U. Højberg, N. J. Kock, J. Krause Sørensen, and S. Chrysidis. "OP0158-HPR TELEMEDICINE CONSULTATIONS IN POLYMYALGIA RHEUMATICA PATIENTS. A TWO YEARS’ EXPERIENCE REPORT." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 100.2–100. http://dx.doi.org/10.1136/annrheumdis-2020-eular.3261.
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Background:Polymyalgia rheumatica (PMR) is the most common inflammatory rheumatic disease of people over 50 years in Scandinavian countries and people of northern European descent, characterized by proximal pain, stiffness, raised inflammatory markers and prompt response to steroids(1). Relapse free during tapering off prednisone, are common in approximately 50% of patients. Studies reported that up to 70% of PMR patients are successfully tapered of prednisone due to remission, within 1-2 years from treatment initiation (1). Telemedicine has found a wider application in a number of chronic diseases resulting in a decreased number of hospital visits; however, no telemedicine studies on PMR patients have been performed before (2).Objectives:To evaluate the use of telemedicine consultation in newly diagnosed PMR patients.Methods:Telemedicine consultations managed by rheumatic nurses for newly diagnosed PMR patients was established in 2017 at our department. Patients diagnosed with PMR by a rheumatologist received written information concerning the nature of the disease, a “follow-up” schedule and a prednisone treatment/tapering plan. Telephone consultations (TC) including relevant blood analysis was planned after 4, 16, 52 and 78 weeks from the time of diagnosis. TC was managed by 4 nurses specialized in rheumatic diseases, who received appropriate education of PMR prior to the establishment. A predefined questionnaire was used for every telephone consultation.All PMR patients were initially treated with 15 mg of prednisone daily, with slowly tapering to 5 mg daily at week 16 and reduced to zero at week 48. In the case of relapse symptoms, patients were instructed to contact the treating nurses. In that case, relevant biomarkers were taken and a rheumatologist evaluated the need for a physical consultation and potential treatment adjustment.Only patients with minimum disease duration of 3 months were included in the study.Results:In a period of two years, 76 patients were evaluated. The mean age was 73 years and the mean follow up period was 10, 67 ± standard deviation (SD) 5,2 months. At the time of diagnosis, all patients fulfilled the 2012 Classifications criteria for PMR (3). The Mean number of TC was 4.27(± SD 2, 3).In 45 cases (60%) no additional physical consultation was necessary. In patients examined physically due to relapse suspicion, the most common findings were PMR relapses (66%), followed by non-inflammatory muscle and joint pain (18,5%), arthritis (14%), while one patient was diagnosed with giant cell arteritis.Successfully prednisone tapering was achieved in 23 cases (30%) while 27 patients (35,5%) at the time of data evaluation were treated with only 2,5 mg of prednisone daily. The mean current daily prednisolone dosage was 3.95 mg (± SD 3.25) while disease-modifying-anti-rheumatic-drugs had been initiated in 6 patients.Conclusion:Telemedicine consultations in PMR diminish the need for physical consultations in this patient cohort. More than half of all patients were either out of- or received only a very low dose of prednisone at the time of evaluation of data.References:[1]Kermani TA, Warrington KJ. Polymyalgia rheumatica. Lancet. 2013 Jan 5;381(9860):63-72. doi: 10.1016/S0140-6736(12)60680-1.[2]Matteo Piga et al. Telemedicine for patients with rheumatic diseases: Systematic review and proposal for research agenda. Semin Arthritis Rheum. 2017 Aug;47(1):121-128. doi: 10.1016/j.semarthrit.2017.03.014. Epub 2017 Mar 22.[3]Dasgupta B, et al. 2012 Provisional classification criteria for polymyalgia rheumatica: A European League Against Rheumatism/American College of Rheumatology collaborative initiative. Arthritis Rheum. 2012; 64: 943-54.Disclosure of Interests:None declared
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Rashad, S., E. Abda, Z. Selim, S. Hussein, T. Metwally, and D. Fouad. "AB1227 PREVALENCE OF RHEUMATIC MUSCULOSKELETAL DISORDERS IN A RURAL AREA OF UPPER EGYPT: WHO-ILAR COPCORD BASED COMMUNITY STUDY." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 1904.3–1905. http://dx.doi.org/10.1136/annrheumdis-2020-eular.779.
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Background:Rheumatic musculoskeletal disorders (RMSDs) are a common cause of long term pain and physical disability. In developed countries, RMSDS are a major cause of absence from work and thus have a big financial burden on the country economic status. Several studies have been published the incidence and prevalence of RMSDs in different world countries and found to be widely variable. Estimation of the extend of the problem of RMSDs in developing world, especially in rural economies will help better understanding of the risk factors that contribute to the initiation and progression of these diseases and help the health care authorities to provide proper health program services in these areas to reduce the physical and financial burden of RMSDs (Bagher et al., 2011; Majumdar et al., 2015 and Usenbo, et al., 2015).Objectives:To estimate the prevalence rate of RMSDs in a rural population in Upper Egypt.Methods:A cross-sectional based study was carried out and included 3988 subjects of population (2013 females and 1975 males). Mean age of patients was (46.89±15.25ys). They proceeded 4 phases of World Health Organization/International League of Associations for Rheumatology community-oriented program for control of rheumatic diseases survey questionnaire WHO-ILAR Community Oriented Program for screening of rheumatic diseases. Modified Health Assessment Questionnaire (HAQ) was used to assess the disability severity. Individuals suspected to have any rheumatic diseases were subjected to full clinical examination, laboratory and radiological investigations to reach a final diagnosis. They were classified according to appropriate criteria of diagnosis of diseases.Results:A prevalence rate of RMSDs was 16.22%, more prevalence in females (10.38% vs. 5.84% for males, P=0.000). The mean age of patients with RRMSDSs were older (46.89±15.25 yrs) than healthy individuals (29.56±18.95 yrs) (P=0.0001) and with increasing age (≥45-≤ 55 yrs).The identified RMSDs were OA (8.5%), Soft tissue rheumatism (STR) (6.57%), spinal disorders (SD) (6.47%), fibromyalgia (FM) (0.60%), RA (0.30%), arthralgia (0.18%), SPAs (0.15%), Gout(0.6%), Pseudogout (0.08%), SLE (0.5%), JIA(0.03) and MCTD (0.03%). The prevalence rates for the majority of RRMSDSs were higher in females and with increasing age. About two thirds of the patients had grade II disability.Conclusion:The prevalence rate of RMSDs in a rural population ≥15years in Upper Egypt has been estimated to be 16.22%.The most prevalent RMSDs are OA, STR and SD causing the greatest burden of the disease. The predictive risk of RMSDs has to be assessed in future studies.References:[1]Majumdar A, Kumar SG, Nair D, Sujiv A. Musculoskeletal complaints and predictors of musculoskeletal pain among adults in rural puducherry. Indian J Palliat Care. 2015; 21(1):121-123.[2]Usenbo A, Kramer V, Young T, Musekiwa A. Prevalence of Arthritis in Africa: A Systematic Review and Meta-Analysis. PLoS One. 2015; 10 (8):e0133858.[3]Bagher OM, Golbarg M, Hossein S. Pattern of rheumatic diseases in two outpatient clinics in Iran: similarities with some different features. Indian J Med Sci. 2011; 65(1):7-17.Disclosure of Interests:None declared
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Chari, Ajai, Hearn Jay Cho, Samir Parekh, Kenneth Lau, Gillian Morgan, Donna Catamero, Melissa Cortes, et al. "A Phase II Study of Pomalidomide, Daily Low Dose Oral Cyclophosphamide, and Dexamethasone in Relapsed/Refractory Multiple Myeloma." Blood 128, no. 22 (December 2, 2016): 4520. http://dx.doi.org/10.1182/blood.v128.22.4520.4520.
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Abstract Background A treatment option for patients with relapsed/refractory multiple myeloma (RRMM) is pomalidomide(pom) and dexamethasone (dex), with an overall response rate (ORR) of 33% and median progression free survival (PFS) of 4.2 months. Adding the alkylatingagent cyclophosphamide(Cy) to pom and steroids improves ORR and PFS. Baz et al (Blood, 26 May 2016) combined daily pom with weekly dosing ofCy anddex (PCD), with an ORR of 64.7% and a median PFS of 9.5 months, although grade 3/4 neutropenia increased from 31% to 52%. In our experience, compared to weekly Cy, low dose daily oral Cy is better tolerated with less myelosuppression. Palumbo et al (Blood, 17 Oct 2013) in fact combined pom with alternate day dosing ofCy and prednisone, with an ORR of 51% and a median PFS of 10.4 months and a grade 3/4 neutropenia rate of 42%. However, importantly, granulocyte stimulating factor (G-CSF) and platelet transfusion support wereprohibited, resulting in a lower maximum tolerated dose of pom of 2.5 mg (vs 4 mg in the Baz) and therefore, the rates of neutropenia cannot be compared between the two studies. In the present study, we explored PCD at the doses/schedule shown in table 1 with hematologic support even in patients with baselinecytopenias. This type of metronomic therapy has demonstrated efficacy in refractory B cell malignancies, possibly because the anti-angiogenic effects of metronomic therapy may be synergetic with conventional anti-neoplastic agents. Methods This was an open label, single arm, and single center phase 2study. The primary objective was to evaluate the best ORR. Secondary objectives were to evaluate safety, clinical benefit response (CBR), PFS, and overall survival (OS). Inclusion criteria included lenalidomide refractory, pom naïve RRMM patients with at least 2 prior lines of therapy. Patients were required to have measurable disease, adequate performance status, Cr <3 mg/dL, normal hepatic function, and ANC > 1000/uL and platelets > 50,000/uL if bone marrow plasma cells were < 50%, otherwise >30,000/uL. G-CSF and platelet support were permitted during screening and study treatment if needed. Each drug was administered at the doses and schedule shown in Table 1. Results Overall, 28 evaluable patients with progressive disease (PD) at screening have been enrolled. The median age is 66 (57% > 65 yr) with a median of 3 lines of prior therapy over 5 years since diagnosis. 3 (11%) had ANC<1.5 and 2 (7%) hadplts<50,000/µL at study entry.High-risk molecular findings were present in 13 patients (46%), including 3 with del p53 and 6 with gain of 1q21 by FISH (2 with concurrentt(4;14) and 2 with concurrent del p53). With 8 patients still on study therapy, responses include 3 complete responses (CR), 7 very good partial responses (VGPR), 9 partial responses (PR), 3 minor responses (MR), 5 stable disease (SD), and 1 PD, for an ORR of 67%, CBR (i.e. MR or better) of 78% and a median PFS of approximately 14.5 months. The median OS has not been reached. The most common grade 3/4 toxicity (regardless of drug attribution) was neutropenia with 20 (71%) of subjects experienced grade 3/4 neutropenia. Importantly, there was only 1 episode of febrile neutropenia during study therapy. Grade 3/4 thrombocytopenia was seen in 25% of subjects, and 3/4 anemia seen in 18%. The most common grade 3/4 non-hematologic toxicity was pulmonary disease with Grade 3 lung infections occurring in 21% of subjects (3 viral, 2 bacterial, 1 unknown) and 1 additional grade 3 URI. Of note, all of these admissions occurred at local hospitals and none of these occurred in the setting of neutropenia. One additional pt hadpneumonitisattributed to pom requiring study discontinuation. Grade 3rashwas also observed in 14% of subjects leading to pom dose reductions. Correlative data from peripheral blood and bone marrow aspirates taken at baseline, Cycle 3 Day 15, and at disease progression from all patients will be updated at the time of conference. These include PCD-associated changesin gene expression, clonal evolution and immune microenvironment during therapy and on progression. Conclusions With toxicities similar to those in other studies, the ORR of 67% and PFS of 14 months in our study of PCD compares very favorably to pomdexas well as other triplet regimens containingCy. Disclosures Chari: Takeda: Consultancy, Research Funding; Array Biopharma: Consultancy, Research Funding; Celgene: Consultancy, Research Funding; Novartis: Consultancy, Research Funding; Janssen: Consultancy, Research Funding; Pharmacyclics: Research Funding; Amgen Inc.: Honoraria, Research Funding. Cho:Genentech Roche: Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen: Consultancy, Research Funding; Agenus, Inc.: Research Funding; Ludwig Institute for Cancer Research: Membership on an entity's Board of Directors or advisory committees; Bristol-Myers Squibb: Membership on an entity's Board of Directors or advisory committees, Research Funding. Catamero:Celgene: Honoraria, Speakers Bureau. Verina:Celgene: Speakers Bureau. Jagannath:Bristol Myer Squibb: Membership on an entity's Board of Directors or advisory committees; Novartis: Membership on an entity's Board of Directors or advisory committees; Janssen: Consultancy, Membership on an entity's Board of Directors or advisory committees; Celgene: Membership on an entity's Board of Directors or advisory committees.
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Huang, He, Jia Tian Lin, Chengcheng Guo, Huangming Hong, Raj Shrestha Prem, Xueying Li, Mengping Zhang, et al. "Predictive Value of Interim 18f-FDG PET-CT Scans on Diffuse Large B-Cell Lymphoma Treated with R-CHOP: A Prospective Study of Chinese Southwest Oncology Group (CSWOG)." Blood 124, no. 21 (December 6, 2014): 3011. http://dx.doi.org/10.1182/blood.v124.21.3011.3011.
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Abstract Purpose 18F-FDG PET-CT has been widely used for pre-treatment staging and post-treatment response assessment in diffuse large B cell lymphoma (DLBCL), but the predictive value of interim PET-CT remained controversial and most of studies were retrospective. Patients and Methods Newly-diagnosed DLBCL patients treated with R-CHOP regimen were included in our prospective study to evaluate the predictive value of interim PET-CT. All patients were evaluated with PET-CT scans before treatment and after every 2 cycles of R-CHOP. PET-CT positivity or negativity was related to survival using Kaplan-Meier analysis. Results From Feb 2008 to Jan 2013, 149 patients were included. After 2 cycles of R-CHOP, the PET-CT evaluation showed CR in 82 patients. Among the remaining 67 non-CR patients, 31 achieved CR after 4 cycles. At the end of treatment, PET-CT evaluation showed CR in 121, PR in 21, SD in 3 and PD in 4 patients. With a median follow-up of 20.6 months (range 1.5-60.5 months), patients with negative PET-2 (PET-CT scan after 2 cycles) had a superior 2-year PFS than those with positive PET-2 (86.6% vs. 67.0%, p=0.019) and a tendency of superior 2-year OS without statistical differences (91.9% vs. 85.2%, p=0.330). The 2-year PFS and OS for negative PET-4 (PET-CT scan after 4 cycles) compared with positive PET-4 group were 84.8% vs. 51.9% (p=0.001) and 93.1% vs. 73.0% (p=0.027) respectively. PET-CT scans were interpreted using the International Harmonization Project (IHP) criteria above. The second analysis applying the Five-Point Scale (5PS) criteria showed that 2-year PFS for score 1-2 (uptake＜mediastinum), score 3 (mediastinum＜uptake≤liver) and score 4-5 (uptake＞liver) group were 86.6%, 75.8% and 71.0% according to PET-2, and 84.9%, 50.0% and 52.7% according to PET-4. PFS of score 3 group was not significant different from the other two groups in PET-2 (both P＞0.05), but significantly inferior to score 1-2 group (p=0.046) and similar to score 4-5 group (p=0.767) in PET-4. In the multivariate analysis, only PET-4 (95%CI, 1.07-5.44) and IPI score (95%CI, 1.53-10.06) remained independent predictive factors for PFS. Conclusion PET-CT after 4 cycles of R-CHOP in patients with DLBCL is highly predictive of PFS and should be considered in clinical practice. (Clinical Trail Registration Number: CTR-TRC-11001687) Disclosures No relevant conflicts of interest to declare.
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Record, Elizabeth, Tamara New, Randall Brown, LeRoy Graham, and R. Clark Brown. "Pulmonary Function in Children with Sickle Cell Anemia Following Treatment with Hydroxyurea." Blood 112, no. 11 (November 16, 2008): 1435. http://dx.doi.org/10.1182/blood.v112.11.1435.1435.
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Abstract Background: Pulmonary function is particularly susceptible to acute and chronic injury occurring in patients with sickle cell anemia (SCA). Acute Chest Syndrome (ACS), a common and potentially fatal complication of SCA, can be the cause or the consequence of abnormal pulmonary function (Siddiqui & Ahmed, 2003). Use of hydroxyurea therapy (HU) is increasing for children with recurrent pulmonary complications, following the findings that HU reduces risk of ACS in adults (Charache et al, 1995). How HU may improve pulmonary function in children with SCA is still ill-defined. The purpose of this study was to assess the change observed on serial pulmonary function tests (PFT) for children prescribed HU for abnormal pulmonary function. Methods: Over 240 children with pulmonary complications, such as acute chest syndrome, reactive airway disease, and chronic hypoxia, have been evaluated in the Sickle Cell Pulmonary Clinic at Children’s Healthcare of Atlanta since beginning in July 2000. As part of the Clinic’s standard of care, PFT were routinely attempted on children over the age of 5. A retrospective review of PFT results was done for the children with SCA and prior abnormal PFT. Children were included in the HU cohort (+HU) if repeat PFTs were available following > 3 months on HU therapy and if time on HU did not include frequent RBC transfusions. Children without history of HU therapy (−HU) were selected for comparison. PFTs were performed on a standard plethysmograph. Paired t-test was used to evaluate observed differences. Results: Thirty-one children with prior abnormal PFT had test before and following prescription of HU. Their mean age was 12.6 (range 6–20) years and mean duration of HU was 21 (range 4–47) months at the time of the repeat PFT. Hematologic changes expected on HU occurred for all 31 children. Twenty-four children followed for abnormal PFT had no history of HU (−HU) and matched the +HU group by gender, age (mean 12.3, range 7–19 years), duration followed at time of repeat PFT (mean 19, range 3–66 months; p=0.36), and initial hematologic parameters. Spirometry findings changed for +HU group, and remained stable for −HU group. Mean FVC and FEV1 values improved significantly on HU, when compared to initial (PreHU) PFT and to −HU controls. Conversion to a normal PFT, as interpreted by a pediatric pulmonologist masked to treatment status, occurred in 18 (58%) and 2 (8%) children in the +HU and −HU groups, respectively. Table 1: Serial PFT and hematologic parameters according to HU exposure −HU (n=24) +HU (n=31) Initial Repeat # PreHU Repeat 1 % predicted value for age, sex and height of subject. 2Mean (SD) #No significant changes compared to Initial, p > 0.05. *P value < 0.001 compared to PreHU; ++P value < 0.001 compared to −HU repeat. PFT parameter 1 TLC 88 (13.6)2 85 (11.7) 85 (13.4) 90 (13.5) FVC 78 (9.8) 79 (9.9) 75 (12.6) 90 (13.2)*,++ FEV1 75 (9.6) 74 (12.2) 72 (11.4) 86 (10.2)*,++ FEF 25-75 75 (22) 72 (28.0) 77 (23.4) 79 (26.8) FEV1/FVC (%) 85(6.7) 82 (9.8) 87 (11.8) 86 (11.1) Pulse oximetry (%) 95 (3.1) 96 (2.4) 94 (4.4) 97 (2.8)* WBC (x103/ul) 14 (3.8) 13 (2.9) 13.02 (2.9) 9.0 (2.1) *,++ Hb (g/dl) 8.0 (0.1) 8.0 (0.9) 7.8 (1.1) 9.1 (1.3) *,++ MCV (fl) 84 (9.2) 85 (10.0) 87.3 (8.1) 101.2 (10.1) *,++ HbF (%) 4.3 (1.5) 5.2 (5.2) 6.0 (3.8) 14.0 (7.3) *,++ Conclusions: Serial PFTs showed improved pulmonary function, following initiation of HU therapy in children with prior abnormal PFT. Routine PFT assessments of children prescribed HU may serve as an objective measure of clinical response in children with SCA and pulmonary complications. These results will help in the design of future prospective studies examining the clinical benefits of HU therapy for children at risk for long-term pulmonary complications.
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Chen, Junmei, Tahsin Özpolat, Colette Norby, Jennie Le, Minhua Ling, Shelby A. Cate, Dominic W. Chung, Xiaoyun Fu, Barbara Konkle, and Jose A. Lopez. "N-Acetylcysteine Treatment in Two Patients with Relapsed Thrombotic Thrombocytopenic Purpura Increased ADAMTS13 Activity, Free Thiol Concentration in Plasma, and Inhibited Platelet Activation." Blood 126, no. 23 (December 3, 2015): 239. http://dx.doi.org/10.1182/blood.v126.23.239.239.
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Abstract Introduction: Thrombotic thrombocytopenic purpura (TTP) is a catastrophic and potentially fatal disorder caused by systemic microvascular thrombosis due to von Willebrand factor (VWF)-platelet thrombi. TTP is caused by congenital or acquired deficiency of the plasma metalloprotease ADAMTS13. Based on an earlier study (Chen J et al., J Clin Invest 2011, 121:593-603), we proposed N-acetylcysteine (NAC) as an adjunct treatment for TTP. This study showed that NAC reduced the size and activity of VWF in vitro in human plasma and in vivo in a TTP mouse model. In 2013 and 2014, two case reports described treatment of refractory TTP patients with NAC, one receiving a low dose of NAC [300 mg/kg (total 15 g) for the 1st 24 hrs, followed by 2.5 g/day for two weeks concurrently with plasma exchange] (Shortt J et al., N Engl J Med 2013, 368: 90-92; Shortt J et al., Transfusion 2014, 54:2362-2363) and the other receiving high-dose NAC [300 mg/kg/day (11 g/day) for 10 days between plasma exchanges] (Li GW et al. Transfusion 2014, 54: 1221-1224). The patient treated with high-dose NAC improved rapidly (the patient woke up from coma 18 hr after NAC treatment was initiated), but the patient treated with lower dose NAC did not appear to respond. Thus, it is as yet unclear whether NAC is an effective treatment for TTP. Therefore, more clinical studies and detailed analyses are required to examine the effects of NAC in TTP patients. Here we report the results of clinical and biochemical studies on two patients with relapsed TTP treated with NAC. Before, during, and after NAC treatment, we determined the concentrations of NAC, cysteine, and glutathione in plasma; VWF concentration, multimer structure, and functions; ADAMTS13 concentration and activity; and platelet counts and activation status (P-selectin expression and phosphatidylserine exposure). Methods: Two females with a history of prior episodes of TTP presented with acute TTP [ADAMTS13 < 10%, positive for ADAMTS13 inhibitors, platelet count ≤ 10,000/uL, lactate dehydrogenase (LDH) > 600 IU/L] and both were treated with NAC per IRB-approved protocol [150 mg/kg bolus over 1 hr and 150 mg/kg as continuous infusion until the next therapeutic plasma exchange (TPE)]. They received daily TPE until their platelet counts normalized, and intravenous NAC during days 2-5. Blood was collected daily for 8 days for research assays. ADAMTS13 concentrations in patient plasma were measured by ELISA. ADAMTS13 activity was measured using HRP-conjugated A2 peptide substrate (Wu J-J et al. J Thromb Haemost 2006, 4:129-136). Concentrations of NAC, total cysteine, and total free thiols (free thiol cysteine and free thiol NAC) in plasma were determined by mass spectrometry. Plasma VWF multimer patterns were analyzed by 1.5% agarose gel electrophoresis followed by western blotting with an HRP-conjugated polyclonal VWF antibody. Platelets in whole blood were labeled for platelet markers (CD41a or CD42b) together with one of the activation markers, P-selectin or phosphatidylserine (lactadherin). The labeled platelets were analyzed by flow cytometry. Results: Platelet counts in both patients started to increase 1 day after NAC infusion and continued to increase after discontinuation of NAC and TPE. After NAC infusion, the free thiol concentration (NAC and cysteine) in plasma increased 4 and 59 fold in patients 1 and 2, respectively. This was accompanied by increasing ADAMTS13 specific activity (ADAMTS13 activity/ADAMTS13 antigen). In patient 1, the specific activity increased from 127% (prior to NAC infusion but after TPE) to 270% during NAC infusion; in patient 2, the specific activity increased from 56% to 86%. In patient 1, the VWF multimer size decreased during NAC treatment and the VWF multimers migrated slightly faster. NAC also appeared to inhibit platelet activation. Before NAC infusion, the platelets in both patients were positive for phosphatidylserine (PS, > 30%) and P-selectin (> 15%), compared to 2% and 5%, respectively, in a normal control. The percentages of PS- and P-selectin-positive platelets decreased to less than 18% and 10% respectively, during NAC treatment. Summary: NAC treatment of two patients with TTP in conjunction with TPE was well tolerated and associated with recovery of platelet count and LDH, increased ADAMTS13 specific activity and total free thiol concentration in plasma, reduced platelet activation, and decreased VWF multimer size in one patient. Disclosures Konkle: CSL Behring: Consultancy; Pfizer: Consultancy; Baxalta: Consultancy, Research Funding; Biogen: Consultancy, Research Funding; Octapharma: Research Funding; Novo Nordisk: Consultancy.
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Czerw, Tomasz, Wlodzimierz Mendrek, Jacek Najda, Malgorzata Sobczyk-Kruszelnicka, Maria Sadus-Wojciechowska, Katarzyna Soska, Magdalena Glowala-Kosinska, et al. "Increased Efficacy of Chemomobilization with Intermediate Dose Cytarabine + G-CSF Compared to G-CSF Alone for Patients with Multiple Myeloma: Results of a Prospective, Randomized Trial." Blood 128, no. 22 (December 2, 2016): 656. http://dx.doi.org/10.1182/blood.v128.22.656.656.
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Abstract INTRODUCTION: High-dose therapy with autologous stem cell support (autologous stem cell transplantation, autoSCT) remains the standard of care for eligible patients with multiple myeloma (MM). Planned tandem autoSCT which can also be considered for all transplant candidates requires collection of at least 5 x 10^6 CD34+ cells/kg. Randomized trials comparing chemomobilization with use of cyclophosphamide (CY) + G-CSF to G-CSF alone did not demonstrate clear advantage of addition of CY to growth factor. In recent years, intermediate-dose cytosine arabinoside (ID-AraC) + G-CSF has been proposed, showing high mobilization potential, as demonstrated in retrospective analysis (Giebel et al, Bone Marrow Transplant 2013, 48: 915-21). The goal of this prospective, randomized trial (ClinicalTrials.gov identifier: NCT01908621) was to compare the efficacy of ID-AraC + G-CSF with G-CSF alone in patients with MM referred for double autoSCT. METHODS: The inclusion criteria were set as follows: 1) the diagnosis of MM, 2) age 18-65 years, 3) at least partial remission achieved after one or more lines of therapy including six or more cycles containing components like thalidomide, lenalidomide , bortezomib, or melphalan, 4) planned tandem autoSCT procedure. The proportion of patients with stem cell yield of at least 5 × 10^6 CD34+ cells/kg was the primary study end-point. Mobilization regimens were as follows: 1) ID-AraC arm - AraC 2 x 0.4 g/m2 on days 1,2 (total 1.6 g/m2) + filgrastim 10 ug/kg/day starting from day 5; 2) G-CSF arm - filgrastim 10 μg/kg/day for five consecutive days. Leukaphereses were started when the level of circulating CD34+ cells in peripheral blood (PB) reached at least 10/uL and were continued for the maximum period of three days or until reaching the target CD34+ cell yield. Leukaphereses were performed using Spectra Optia Apheresis System, Mononuclear Cell Collection Procedure (Therumo BCT Inc., Lakewood, CO, USA), processing 2 total blood volumes. RESULTS: Between March 2013 and March 2016, 44 and 46 patients were randomly assigned to ID-AraC and G-CSF study arm, respectively. Patients in the ID-AraC arm were younger (median age 56 years, range (33-65) for ID-AraC and 60 years (37-65) for G-CSF, p=0.04). The groups did not differ in terms of MM remission status at mobilization (p=0.3), the number of preceding lines of chemotherapy (p=0.5) and the frequency of preceding radiotherapy (p=0.4). The level of CD34+ cells in PB required to start leukaphereses was achieved in all patients in the ID-AraC arm and in 44 (96%) of them in the G-CSF arm, p=0.2. In the ID-AraC group, 43 patients (98%) collected at least 5 x 10^6 CD34+ cells/kg compared to 32 patients (70%) in the G-CSF group (p=0.0003). In a multivariate model adjusted for age, the use of G-CSF alone was independently associated with increased risk of mobilization failure (Odds ratio = 17.5; 95% CI = 2.1-144.9; p=0.007). The median peak number of circulating CD34+ cells was 346 (11-1044)/µL vs. 40 (1-326)/µL (p<0.000001), while the median number of collected CD34+ cells was 20.2 (2.9-59.4) x10^6/kg vs. 5.9 (0-11) x10^6/kg, respectively (p<0.000001). A single apheresis was sufficient to achieve the threshold number of harvested CD34+ cells in 37 of cases (86%) after ID-AraC+G-CSF compared to 13 (41%) after G-CSF alone (p=0.00008). The median day of the first apheresis was 13 (range, 12-15; SD=0.7) after ID-AraC. CONCLUSIONS: Mobilization with ID-AraC + G-CSF is associated with significantly higher efficacy than G-CSF alone. In the studied group it allowed for collection of CD34+ cell number adequate for tandem autoSCT in almost all MM patients, usually with a single leukapheresis. This study provides the first evidence coming from prospective, randomized trial for the advantage of chemomobilization over G-CSF monotherapy in terms of proportion of patients achieving CD34+ yield sufficient for autoSCT. Disclosures No relevant conflicts of interest to declare.
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Munadi, Muhammad, and Watik Rahayu. "Inculcation Religiosity in Preschoolers Local content curriculum." JPUD - Jurnal Pendidikan Usia Dini 13, no. 2 (November 30, 2019): 201–16. http://dx.doi.org/10.21009/jpud.132.01.
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Millennial era life is a big challenge, humans need a strong footing to face all the problems. Religion is God's guidance that becomes the handle of life and it is important to instill religious beliefs early on. The purpose of this study was to find the cultivation of religiosity in preschool children in Kindergarten Aisyiyah Branch and Kindergarten Santa Maria in Kartasura Regency. This study uses qualitative methods with data collection tools, namely interviews, direct observation, and document analysis. Data validated using triangulation of methods and sources. The results showed that the religiosity of planting in the TK Aisyiyah Kartasura branch had more burdens than in the Santa Maria Kindergarten. While its nature is more balanced between vertical ritual content and horizontal content in TK Aisyiyah Kartasura branches compared to TK Santa Maria. The cultivation of moral education is carried out through a step-by-step process starting with teaching to say and answer greetings (Islam), saying good morning and evening to non-Muslims and inviting children to always pray in every activity. Vertical ritual planting in TK Aisyiyah Kartasura branch has more burden through the practice of prayer, memorizing prayers and memorizing short letters from the Qur'an all in Arabic compared to TK Santa Maria only emphasizes the memorization of prayer in Indonesian.
Keywords: Inculcation religiosity, Pre-schoolers, Local content curriculum
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Papanikolaou, Xenofon, Rashid Z. Khan, Adam Rosenthal, Clyde Bailey, Yogesh Jethava, Christoph Heuck, Susan B. Panozzo, et al. "Further Evolution of Metronomic Therapy Extended to 28 Days (Metro28) for Relapsed Refractory Multiple Myeloma (RRMM)." Blood 124, no. 21 (December 6, 2014): 2128. http://dx.doi.org/10.1182/blood.v124.21.2128.2128.
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Abstract Despite the increasing availability of novel agents for RRMM, many patients run out of treatment options due to disease refractoriness and/or progressive toxicities, both hematological (cytopenia) and non-hematological (cachexia, asthenia, renal and cardiopulmonary).Patients who are refractory to both proteasome inhibitors and immunomodulatory agents (IMIDs) carry an ominous prognosis with a median overall survival (OS) of 9 months (Leukemia, Kumar 2013). We previously reported on the efficacy and toxicity profiles of a metronomically scheduled chemotherapy regimen administered over the course of 16 days (Haematologica, Papanikolaou 2014). Encouraged by the results of that treatment, we have since modified metronomic chemotherapy to cover a 28-day period (metro28). The regimen consisted largely of bortezomib 1.0mg/m2 on days 1, 4, 7, 10, 13,16,19, 22,25,28; along with dexamethasone 12mg on days 1-4, 7-10, 13-16, 19-22, 25-28; thalidomide 100mg days 1-28, continuous 28 day infusion of doxorubicin 1.0mg/m2 (0.5mg/m2 for Ejection Fraction <40%) and cis-platinum 1.0mg/m2 (0.5mg/m2 for creatinine >2mg/dL), with the addition of arsenic trioxide (ATO) at 0.1mg/kg on each day after bortezomib; and lately vincristine (VCR) at 0.07mg daily dose by continuous infusion for 28 days. Patient characteristics included age >65yr, 46%; female, 33%; cytogenetic abnormalities at any time prior to therapy (CA), 86%; Gene Expression Profile (GEP) 70-defined high risk, 44%. The median number of prior therapies was 8 (1-64), prior transplants, 83% (1, 2, >=3), 20%, 32%, 31%; prior exposure to novel agents including Carfilzomib/Pomalidomide was 81%. Thrombocytopenia prior to treatment was present in 75% including thrombocytopenia <50,000/uL in 15%. Clinical outcomes are depicted in Figure 1. At a median follow up of 8.1 months, the median number of metro 28 cycles administered was 1 (1-5), with 37% achieving a partial response and median OS not yet reached. Interestingly, the 6 month - partial response duration estimate for the patients achieving PR was 53% (Figure 1A), while the one year OS estimate for all patients receiving metro 28 was 59% (Figure 1B). Prognostic factors that held statistical significance in univariate analysis for overall survival were albumin <3.5 g/dl (HR 2.56, P=0.009), beta-2-microglobulin (B2M) ≥3.5 mg/L (HR 3.03, P=0.003), LDH≥ 190 U/L (HR 2.81, P=0.003), GEP-70 High Risk (HR 2.32, P=0.048), GEP-5 High Risk (HR 5.75, P<0.001) (Figure 1C) and GEP PR subgroup designation (HR 3.71, P=0.003). In multivariate analysis, albumin < 3.5 g/dL (HR 2.81, P=0.035), B2M≥ 3.5 mg/L (HR 3.4, P=0.017), GEP PR subgroup (HR 3.8, P=0.012), and GEP-5 High Risk (HR 8.58, P<0.001) (Figure 1C) achieved statistical significance. The majority of cycles administered in the patient population were done in the outpatient setting (81%), while secondary admissions due to regimen toxicity occurred in 36% of the cycles administered. Grade 3 & 4 neutropenia and thrombocytopenia within 3 months from the start of the metronomic treatment were evident in 64% and 78% respectively of the cases. Treatment related mortality was 2%, due to one instance each of grade 5 infection and cerebrovascular event. In conclusion 28 day metronomic therapy is a feasible treatment with acceptable toxicity and encouraging preliminary results both in terms of ORR and OS for RRMM. Table 1: Patient characteristics at start of Metro28 therapy Factor n/N (%) Age >= 65 yr 56/122 (46%) IgA Isotype 28/110 (25%) Female 40/122 (33%) White 108/122 (89%) Albumin < 3.5 g/dL 47/122 (39%) B2M >= 3.5 mg/L 46/93 (49%) B2M > 5.5 mg/L 26/93 (28%) CRP >= 8 mg/L 54/122 (44%) Creatinine >= 2 mg/dL 15/122 (12%) Hb < 10 g/dL 57/122 (47%) LDH >= 190 U/L 36/121 (30%) Platelet Count < 150 x 10^9/L 92/122 (75%) Cytogenetic abnormalities 105/122 (86%) CA within 1 year of therapy 84/121 (69%) CA within 90 days of therapy 65/119 (55%) New Kit GEP Sample 91/91 (100%) GEP 70 High Risk 40/91 (44%) GEP 5 High Risk 39/91 (43%) GEP CD-1 subgroup 5/91 (5%) GEP CD-2 subgroup 17/91 (19%) GEP HY subgroup 14/91 (15%) GEP LB subgroup 6/91 (7%) GEP MF subgroup 9/91 (10%) GEP MS subgroup 9/91 (10%) GEP PR subgroup 31/91 (34%) GEP proliferation index >= 10 28/91 (31%) GEP centrosome index >= 3 26/91 (29%) n/N (%): n- Number with factor, N- Number with valid data for factor ND: No valid observations for factor Figure 1A Figure 1A. Figure 1B Figure 1B. Figure 1C: OS by GEP5 Figure 1C:. OS by GEP5 Disclosures Zangari: Norvartis: Membership on an entity's Board of Directors or advisory committees; Onyx: Research Funding; Millennium: Research Funding. van Rhee:Janssen: Membership on an entity's Board of Directors or advisory committees; Celgene: Membership on an entity's Board of Directors or advisory committees; Millenium: Membership on an entity's Board of Directors or advisory committees; Sanofi: Membership on an entity's Board of Directors or advisory committees. Morgan:Celgene Corp: Membership on an entity's Board of Directors or advisory committees; Novartis: Membership on an entity's Board of Directors or advisory committees; Janssen: Membership on an entity's Board of Directors or advisory committees; Myeloma UK: Membership on an entity's Board of Directors or advisory committees; International Myeloma Foundation: Membership on an entity's Board of Directors or advisory committees; The Binding Site: Membership on an entity's Board of Directors or advisory committees; MMRF: Membership on an entity's Board of Directors or advisory committees.
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Aoki, Naomi J., Kylie Venardos, Nick Andrianopoulos, Zoe K. Mcquilten, Amanda J. Zatta, Claire McLintock, Helen Savoia, and Erica M. Wood. "Use of Blood Components in Major Obstetric Hemorrhage: Preliminary Findings from the Australian and New Zealand Massive Transfusion Registry (ANZ-MTR)." Blood 124, no. 21 (December 6, 2014): 1563. http://dx.doi.org/10.1182/blood.v124.21.1563.1563.
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Abstract Introduction: Major obstetric hemorrhage (MOH) can develop rapidly and, due to the unique characteristics of maternity patients, early recognition and management can be challenging. Use of blood components in MOH can be life-saving however there is uncertainty about optimal use of these products and the role of adjunctive therapies. The ANZ-MTR generates observational data on current transfusion management and outcomes in critically bleeding patients receiving massive transfusion (MT) across all clinical settings. This study aimed to describe the transfusion strategies used in the MOH population and report their outcomes. Methods: Patients who had a MOH and received a MT (≥5 units of red blood cells [RBC] in 4h) between April 2011 and December 2013 at 15 Australian & NZ hospitals were identified. Data on the type and volume of blood products transfused as well as selected laboratory results and clinical outcomes were reviewed. Results: A total of 154 cases were identified and reviewed, representing 6% of the total ANZ-MTR cohort. Median age was 34 [IQR29-37] years and 99% of women had a Charlson Comorbidity Index score ≤ 1. Table 1 presents the blood products transfused. The median [IQR] fresh frozen plasma (FFP) to RBC ratio and platelets to RBC ratio was 0.6 [0.3-0.8] and 0.1 [0-0.2], respectively. FFP, platelets and cryoprecipitate were transfused in 87%, 66% and 49% of patients. Prothrombinex-HT was administered to 1 patient and 3 patients received rFVIIa. Table 2 presents the laboratory results taken prior to MT onset as well as the lowest and highest result reported within 24hours after the MT onset. Fibrinogen levels following MT onset was available for 121 (79%) patients. Of these, 46% women had a fibrinogen level <2 g/L of which 34% did not receive cryoprecipitate. Mean [SD] hemoglobin level 24h post-MT onset was 108g/L [19]. Regarding patient outcomes, median [IQR] hospital length of stay was 8 [4-43] days, 59 (38%) women were admitted to ICU, 40 (26%) underwent a subtotal or total hysterectomy and 3 (1.9%) died in-hospital. Table 1. Number of patients and median number of units transfused 24h post-MT onset (n = 154). Blood product n (%) Median units (IQR) Red blood cells 154 (100) 7 [6-10] Fresh frozen plasma 134 (87) 4 [2-6] Platelets 102 (66.2) 1 [0-1] Cryoprecipitate 76 (49.4) 0 [0-5] Table 2. Laboratory values* reported Value prior to MT onset Lowest value 0-24h post-MT onset Highest value 0-24h post-MT onset Hemoglobin (g/L) 102 [81-120], 84 77 [67-90]; 92 108 [95-119]; 92 INR 1.1 [0.9-1.2]; 33 1.1 [.9-1.2]; 72 1.3 [1.1-1.4]; 72 aPPT(s) 31 [28-35]; 39 31 [29-34]; 88 37 [33-46]; 88 Fibrinogen level (g/L) 3.2 [1.6-3.9]; 25 1.9 [1.4-2.6]; 79 2.9 [2.5-3.5]; 79 Platelet Count (109/L) 210 [158-249];84 102 [74-135]; 92 146 [110-190]; 92 pH 7.3 [7.3-7.4]; 22 7.3 [7.2-7.3]; 70 7.4 [7.4-7.5]; 70 *Data are Median [IQR]; % patients with laboratory test available Conclusion: Women with MOH requiring massive transfusion were generally healthier and younger than patients of other clinical contexts in the ANZ-MTR. Although there were few in-hospital deaths reported (1.9%), a large proportion of the cohort required a hysterectomy during their hospital admission. Further information on transfusion practice, including understanding optimal blood component ratios, is required to inform clinical practice and minimize risk in the obstetric setting. Disclosures McLintock: Novo Nordisk Australasia: Honoraria.
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Hagiwara, May, Aaron Moynahan, Ze Cong, Yaozhu J. Chen, Emilie Duchesneau, Dana Hurley, and Thomas E. Delea. "Patterns of Medication Use in Patients with Relapsed and/or Refractory Multiple Myeloma." Blood 126, no. 23 (December 3, 2015): 4497. http://dx.doi.org/10.1182/blood.v126.23.4497.4497.
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Abstract Background For patients with multiple myeloma (MM) who are refractory to or relapsed after initial therapy, current US clinical guidelines recommend treatment with proteasome inhibitors (PIs) (e.g., bortezomib [V] or carfilzomib [K]) and/or immunomodulatory drugs (IMiDs) (e.g., lenalidomide [R], thalidomide [T] or pomalidomide [P]), combined with corticosteroids. Data on the real world use of these medications, such as rate of initiation of a new line of therapy (LOT), treatment regimens within LOTs, and duration of treatment (DOT), among US patients with relapsed and/or refractory MM are limited. Methods This was a retrospective cohort study of medication use patterns among US patients with MM who were refractory to or relapsed after initial therapy. Data were from the MarketScan commercial and Medicare research databases between Jan 2006 and Dec 2013 (study period). Study patients included adults who were diagnosed with MM (ICD-9-CM code 203.0x) and initiated second line (2L) therapy during the study period, and were continuously enrolled from ≥180 days prior to MM diagnosis to ≥30 days after initiation of 2L. LOT was identified using claims for PIs, IMiDs, and other MM treatments; corticosteroids were not used in identification of LOTs. Treatment regimens were defined based on claims for MM therapies during the first 90 days after start of a LOT. The start date of a new LOT (and the end date of the current LOT) was identified based on the date of the first claim for a new MM therapy (i.e., not in the current regimen), a claim for any MM therapy after a gap of >90 days without a claim for any MM therapy, or end of follow-up (EOF), whichever occurred first. Time within LOT was separated into on- and off-therapy periods; on-therapy period ended on the date of the last claim during the LOT for any therapy in the regimen (or for the last LOT, EOF if the last claim during the LOT was <90 days from EOF). The distribution of MM patients by treatment regimen was assessed by LOT (2L, third line [3L], and fourth or subsequent line [4L+]) and by date of LOT initiation (Jan 2006 - May 2008, Jun 2008 - Jun 2012, and Jul 2012 - Dec 2013). Kaplan-Meier estimates of DOT were calculated for each regimen by LOT (2L and third or subsequent line [3L+]). Patients were censored if last claim for MM therapy was <90 days from EOF. For reporting purposes, regimens were classified into 6 mutually-exclusive categories: K-based regimens (any K), P-based regimens (P, no K), R-based regimens (R, no K or P), V-based regimens (V, no K, P, or R), T-based regimens (T, no K, P, R or V), and other regimens (other MM medication, no K, P, R, V, or T). An additional analysis based on all prevalent MM patients with 1+ day of enrollment in 2013 was conducted to estimate the rate of MM therapy new starts by LOT and patient's age/sex. Results A total of 4,693 patients were included in the study, representing 7,683 LOTs (2L=4,693, 3L=1,868, and 4L+=1,122); 56% were male, 59% were in commercial plans, and 20% had transplant before 2L. Mean (SD) age at 2L initiation was 64 (12) years. Use of R-based regimens was greatest in 3L. Based on the regimen classification described above, use of V-based regimens was similar across LOTs (Figure 1A); P- and K-based regimens were used infrequently (<2% of all LOTs) and predominantly in 3L and 4L+. Over time, use of T-based regimens and regimens without PIs or IMiDs decreased in all LOTs while use of R- or V-based regimens increased in all LOTs (Figures 1B-1D). Median DOT (in days) was similar in 2L and 3L+ and was longer for R-based regimens (2L: 277 days; 3L+: 282 days) vs. other regimens (2L: 121-180 days; 3L+: 155-171 days) (Figure 2). Among 3,329 prevalent MM patients identified in the additional analysis, the rate of new starts per 100 person-years was 17.7 for 1L, 8.1 for 2L, 3.7 for 3L, and 2.7 for 4L+ (Table 1). Conclusions Among relapsed or refractory MM patients in the US, use of R- and V-based regimens increased since 2008, while the use of T-based regimens declined. The portion of patients receiving K- and P-based regimens was small but increasing. Median duration of therapy of R-based regimens was about 100 days longer than that of other regimens. These data could be useful for economic evaluations and research and budget planning. Table 1. Rate of New Starts on MM Therapy per 100 Person Years (PSY) Sex, Age PSY 1L 2L 3L 4L+ Female, <65 2,527 18.1 8.4 4.2 3.0 Female, ≥65 2,412 15.1 6.2 3.0 2.3 Male, <65 2,818 21.4 10.5 4.6 3.2 Male, ≥65 3,034 16.0 7.1 2.8 2.3 Total 10,791 17.7 8.1 3.7 2.7 Disclosures Hagiwara: Onyx Pharmaceuticals: Research Funding. Moynahan:Onyx Pharmaceuticals: Research Funding. Cong:Onyx Pharmaceuticals: Employment, Equity Ownership. Chen:Onyx Pharmaceuticals: Employment. Duchesneau:Onyx Pharmaceuticals: Research Funding. Hurley:Onyx Pharmaceuticals: Consultancy. Delea:Onyx Pharmaceuticals: Research Funding.
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Steinmetz, H. Tilman, Roja Wahdat, Burkhard Haastert, Annette Sauer, Bernd Lathan, Christian Lerchenmüller, Hans Tesch, Ulrich Germing, and Stephan Schmitz. "Prognosis of Myelodysplastic Syndromes (MDS) in Patients in the Age of 80 Years and Older: Data from the Regular Care MDS Registry in Germany." Blood 128, no. 22 (December 2, 2016): 4333. http://dx.doi.org/10.1182/blood.v128.22.4333.4333.
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Abstract The international prognosis scoring system (IPSS) and the revised-IPSS were generated with data from 816 and 7,019 patients (pts) from academic centers with a median age of 69 and 71 years (y) respectively. As the median age of pts with MDS receiving care in Germany is 74.9 y and around a quarter of pts are older than 80 y, the aim was to evaluate the meaning of the IPSS and additional risk factors in the older population group. Methods: Pts with written informed consent could be included in the online-registry. Pts were eligible if a bone marrow examination had been performed and if basic data and the quarterly course of the disease were documented. Statistical analysis: Depending on the distributions of each variable frequency tables, means (SD), medians were calculated overall and stratified by age classes. Corresponding overall tests were performed (Chi-square, Kruskal-Wallis). Time dependent survival probabilities from MDS diagnosis were estimated by Kaplan Meier curves (compared using log rank test). Multiple Cox regression models were used to investigate associations between mortality risk and baseline risk factors. Variable selection was performed in the subpopulation of elderly pts based on univariate models and models including all prespecified variables (IPSS, sex, transfusion dependent at diagnosis (Tx at d), primary or secondary MDS, comorbidities). Mortality of pts subgroups was compared and age-sex-standardized with the German population 2013 as given in the Human Mortality Database (www.mortality.org, University of California Berkeley, Max Planck Institute for Demographic Research). Standardized mortality rates (SMR) and 95%-confidence intervals were estimated. Results: Between July 2009 and March 2016 (81 months) 2,118 pts from 90 institutions, mainly outpatient practices, were documented. The median age of the 843 (39.8%) female and 1,275 (60.2%) male pts was 74.9y (min-max: 26.5 - 94.2). 631 patients were excluded from analysis due to missing IPSS risk. The duration of observation, frequencies of IPSS, Tx at d, and the Charlson comorbidity index (CCI) are given in the table. Increased age and IPSS risk were significantly associated with the risk of death. An additional interaction between age and IPSS risk was significant (p=0.0198, Cox model, lower IPSS risk in increased age). In the subgroup of elderly patients (n=332, 147 died) after variable selection, IPSS, gender and Tx at d (22 missings) were significantly associated with the risk of death. Furthermore, even in the low risk group an elevated risk was estimated (SMR 1.773) compared to the normal population in the same age class. SMRs increase with higher IPSS risk. Analysis of comorbidities using CCI showed no significant association with mortality in the low risk group of the elderly patients (n=121, 44 died). Because of low sample sizes in the CCI subgroups the power is small, but even the survival curves did not show a clear trend (p= 0.497). Conclusion: IPSS risk and age are significantly associated with the risk of death. In elderly pts associated risk factors were IPSS, male gender and transfusion at diagnosis. Even the diagnosis of low risk MDS has a negative impact on life expectancy. Supported by an unrestricted grant from Celgene and Novartis. Table 1 Table 1. Figure Figure. Table 2 Table 2. Disclosures Steinmetz: Vifor: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; BMS: Membership on an entity's Board of Directors or advisory committees; Amgen: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Celgene: Consultancy, Research Funding, Speakers Bureau. Haastert:X-Med: Honoraria. Tesch:Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Schmitz:Celgene: Consultancy, Research Funding; Novartis: Consultancy, Research Funding; Amgen: Speakers Bureau.
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Adam, Jean-Philippe, Emilie Lemieux-Blanchard, Bernard Lemieux, and Nathalie Letarte. "Targeting Patient at High Risk of Thrombocytopenia and Neutropenia with Cybord, Vel-Dex and VMP: Time to Decrease the Number of Blood Tests ?" Blood 124, no. 21 (December 6, 2014): 1295. http://dx.doi.org/10.1182/blood.v124.21.1295.1295.
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Abstract Introduction Subcutaneous (SC) injection of bortezomib is more convenient for patients and staff. In September 2012, we standardised all bortezomib containing-protocols at our centre and changed the route of administration form intravenous to SC. Hematologic toxicity is commonly reported with these protocols. Currently, in our protocols, a complete blood count (CBC) is needed before every injection. Objectives This retrospective study aimed to analyse the rate of neutropenia and thrombocytopenia with Vel-Dex, VMP and CyBorD based on a threshold at day 1 to see if a CBC is needed before every injection in all patients. Blood pressure (BP) was measured before and after each SC injection to evaluate the risk of hypotension. Methods This retrospective study included all patients who received SC bortezomib in Vel-Dex, VMP and CyBorD protocols for multiple myeloma or amyloidosis at the Centre hospitalier de l'Université de Montréal (CHUM) between June 1, 2012 and May 31, 2013. Data was collected through medical and pharmaceutical patient records. Our local ethics board approved this study. Our main outcome is defined as the presence of neutropenia and thrombocytopenia for CyBorD (days 1, 8, 15 and 22 q 28 days), Vel-Dex (days 1, 4, 8 and 11 q 21 days) and VMP (days 1, 8, 22 and 29 q 42 days or days 1, 8, 15, 22 q 35 days) dichotomized at a threshold of ≥ 1.5 x 109 and ≥ 75 x 109respectively. A McNemar Test was used to estimate the association between the neutropenia and thrombocytopenia based on the dichotomized value on day 1. Results A total of 69 patients received bortezomib for MM (65 patients) or amyloidosis (4 patients). Median age was 67 years (SD ± 9.1) and 58 % of patients were male. Patients received Vel-Dex (23.2%), VMP (36.2%) and CyBorD (40.6%) protocols in 1st line eligible to stems cells transplant (26.2%), 1st line non-eligible (40.0%) or ≥ 2nd line (33.8%) for a total of 349 cycles. The median starting dose of bortezomib was 1.3 mg/m2 (SD ± 0.14). As shown in tables I and II, there is a statistical evidence of association when neutrophils ≥ 1.5 x 109 and platelets ≥ 75 x 109 at day 1 with the minimum of neutrophils and platelets on the CBC for the rest of the cycle of CyBorD and VMP. For Vel-Dex no significant association was seen because the incidence of neutropenia and thrombocytopenia is very low and doesn’t depend on a threshold at day 1. A patient, who has values above this threshold at day 1, could receive the rest of the cycle (Vel-Dex, CyBorD or VMP) without additional CBCs. When patients had blood counts below this threshold, chemotherapy was delayed 18 times (generally at day 1) or cancelled 39 times (other days). Patient previously exposed to many lines of therapy tend to have lower neutrophils or platelets counts. Also, a total of 1224 BP values before after SC bortezomib were analysed. No significant difference was detected between the average systolic (122 vs 122; p=0.43) and diastolic BP (70 vs 71; p=0.33) before and after treatment. Hypotension, defined as a drop of 20 mmHg of systolic BP, occurred 37 times (3.0%) but systolic BP was never below 90 mmHg and treatment was not necessary. A small increase of heart rate (82 vs 84; p<0.001) was seen although it was not clinically significant. Table I: Rate of neutropenia during the cycle according to day-1 neutrophil counts Protocols CyBorD VMP Vel-Dex Neutrophils at day 1 of each cycle n ≥ 1.5 n < 1.5 p value n ≥ 1.5 n < 1.5 p value n ≥ 1.5 n < 1.5 p value Neutrophils ≥ 1.5 for the rest of the cycle 81.8 % 20 % p<0.001 77.8 % 0 % p<0.001 95.5 % 100 % NS Neutrophils < 1.5 for the rest of the cycle 18.1 % 80 % 22.2 % 100 % 4.5 % 0 % TOTAL of cycle 121 25 - - - 117 7 - - - 67 2 - - - Table II: Rate of thrombocytopenia during the cycle according to day-1 platelet counts Protocols CyBorD VMP Vel-Dex Platelets at day 1 of each cycle Plt ≥ 75 Plt < 75 p value Plt ≥ 75 Plt < 75 p value Plt ≥ 75 Plt < 75 p value Platelets ≥ 75 for the rest of the cycle 97.7 % 15.4 % p<0.001 83 % 33.3 % p<0.001 98.5 % 0 % NS Platelets < 75 for the rest of the cycle 2.3 % 84.6 % 17 % 66.7 % 1.5 % 100 % TOTAL of cycle 133 13 - - - 141 3 - - - 68 1 - - - Conclusion Our results demonstrate that the rate of thrombocytopenia and neutropenia was very low in patients who have neutrophils and platelets ≥ 1.5 x 109 and ≥ 75 x 109 at day 1 of each cycle of Vel-Dex, VMP and CyBorD. In these patients, no CBC seems necessary for the rest of cycle. Decreasing the number of CBC will use less resources, decrease costs and most importantly, improve the patient’s care by minimising interventions without increasing risk of adverse events. Disclosures Adam: Janssen: Honoraria. Lemieux-Blanchard:Celgene: Honoraria. Lemieux:Janssen: Honoraria.
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Yazici, A., Ö. Özdemir Işik, E. Dalkiliç, S. S. Koca, Y. Pehlivan, S. Şenel, N. Inanc, et al. "AB0229 A NATIONAL, MULTICENTER, SECONDARY DATA USE STUDY EVALUATING EFFICACY AND RETENTION OF FIRST-LINE BIOLOGIC TREATMENT WITH TOCILIZUMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS IN REAL-LIFE SETTING FROM TURKBIO REGISTRY." Annals of the Rheumatic Diseases 80, Suppl 1 (May 19, 2021): 1140–41. http://dx.doi.org/10.1136/annrheumdis-2021-eular.2928.
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Background:Tocilizumab (TCZ) is a human anti-interleukin (IL)-6 receptor antibody approved in Turkey for the treatment of rheumatoid arthritis (RA).Objectives:In this study our purpose was to describe the disease activity, quality of life (QoL), and retention rate in RA patients who were prescribed TCZ as first-line biologic treatment in a real-world setting.Methods:Anonymized patient registry of TURKBIO was used based in a national, multicenter, and retrospective context. We conducted a search in the registry between years 2013 and 2020 and included adult RA patients who were prescribed with TCZ as their first-line biologic treatment with a post-TCZ follow-up of at least 6 months. CDAI, DAS28-(ESR), and HAQ-DI scores in 6, 12, and 24 months were obtained. Pairwise comparison was carried out for survey scores across baseline and timepoints. Subgroup analysis for route of TCZ administration was performed. EULAR response criteria were used for response evaluation. Retention of TCZ was evaluated by Kaplan-Meier analysis.Results:Overall,130 patients with a mean RA duration of14 years were included in the study. 87.7% of the patients were female and mean age was53 (SD; 15.0). Median duration of follow-up was 18.5 months. Majority (90.8%) of patients were given tocilizumab via intravenous route at baseline. Number of patients with ongoing TCZ treatment and follow-up at 6, 12, and 24 months were 121 (93%), 85 (65%), and 46 (35%), respectively. Remission rates at 6, 12, and 24 months per CDAI (<2.8) and DAS28-(ESR) (<2.6) scores were 61.5%, 44.6%, 30%, and 54.6%, 40.8%, 27.7%, respectively. CDAI, DAS28-(ESR) and HAQ-DI survey scores significantly improved at 6, 12 and 26 months, respectively (p<0.001) (Table 1) in both IV and SC TCZ subgroups. At 6, 12 and 24months 74.8%, 82.5% and 86.4% of patients achieved a EULAR good response respectively. Twenty-three patients (17.6%) discontinued TCZ at 24 months. Of these, 19 patients discontinued due to unsatisfactory response. Retention rates of TCZ at 6, 12, and 24 months were 93%, 84.3%, and 72.2%, respectively (Figure 1).Conclusion:TCZ as a first-line biologic treatment was found to be clinically effective in this real-world study with a high retention rate. These results are in line with the results gathered from previous TCZ controlled and real-life studies in which TCZ was found clinically safe and effective.References:[1]Haraoui B, Casado G, Czirjak L, Taylor A, Dong L, Button P, Luder Y, Caporali R. Tocilizumab Patterns of Use, Effectiveness, and Safety in Patients with Rheumatoid Arthritis: Final Results from a Set of Multi-National Non-Interventional Studies. Rheumatol Ther. 2019 Jun;6(2):231-243.[2]Favalli EG, Raimondo MG, Becciolini A, Crotti C, Biggioggero M, Caporali R. The management of first-line biologic therapy failures in rheumatoid arthritis: Current practice and future perspectives. Autoimmun Rev. 2017 Dec;16(12):1185-1195.[3]Haraoui B, Jamal S, Ahluwalia V, Fung D, Manchanda T, Khraishi M. Real-World Tocilizumab Use in Patients with Rheumatoid Arthritis in Canada: 12-Month Results from an Observational, Noninterventional Study. Rheumatol Ther. 2018 Dec; 5(2): 551–565.Disclosure of Interests:Ayten Yazici Speakers bureau: PFIZER, AbbVie, NOVARTIS, Özlem Özdemir Işik: None declared, Ediz Dalkiliç Speakers bureau: AbbVie, UCB Pharma, PFIZER, Roche, MSD, NOVARTIS, Süleyman Serdar Koca Speakers bureau: MSD, NOVARTIS, GILEAD, PFIZER, ABDI IBRAHIM, UCB Pharma, AMGEN, SANOFİ, Yavuz Pehlivan Speakers bureau: PFIZER, NOVARTIS, MSD, CELLTRION, Consultant of: PFIZER, Soner Şenel: None declared, Nevsun Inanc Speakers bureau: NOVARTIS, PFIZER, ABDI IBRAHIM, JANNSEN, Paid instructor for: NOVARTIS, PFIZER, ABDI IBRAHIM, JANNSEN, Consultant of: NOVARTIS, PFIZER, ABDI IBRAHIM, JANNSEN, Grant/research support from: NOVARTIS, PFIZER, ABDI IBRAHIM, JANNSEN, Servet Akar Speakers bureau: LILLY, MSD, NOVARTIS, GILEAD, PFIZER, ABDI IBRAHIM, JANNSEN, UCB Pharma, AMGEN, Paid instructor for: LILLY, NOVARTIS, GILEAD, PFIZER, ABDI IBRAHIM, UCB, AMGEN, Grant/research support from: PFIZER, Sema Yilmaz: None declared, Özgül Soysal Gündüz: None declared, Ayse Cefle Speakers bureau: UCB Pharma, PFIZER, MSD, AbbVie, AMGEN, NOVARTIS, Fatos Onen Speakers bureau: AbbVie, LILLY, MSD, NOVARTIS, GILEAD, PFIZER, ABDI IBRAHIM, JANNSEN, UCB Pharma, AMGEN, İbrahim Etem-MENARINI, Paid instructor for: AbbVie, LILLY, NOVARTIS, GILEAD, PFIZER, ABDI IBRAHIM, UCB Pharma, AMGEN, İbrahim Etem-MENARINI, Grant/research support from: PFIZER
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Sumadi, Tjipto, Elindra Yetti, Yufiarti Yufiarti, and Wuryani Wuryani. "Transformation of Tolerance Values (in Religion) in Early Childhood Education." JPUD - Jurnal Pendidikan Usia Dini 13, no. 2 (December 13, 2019): 386–400. http://dx.doi.org/10.21009/jpud.132.13.
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Religious tolerance is a supporter of social harmony and brings a country to a better life. Instilling tolerance in early childhood is a challenge for early childhood educators. This study aims to describe the transformation of religious tolerance values by teachers in early childhood education. This research is a type of qualitative case study research model with researchers as observer participants. This research produces the following findings, that (1) transformation of tolerance values among religious communities, is explicitly not taught in Early Childhood Education (ECE) on the grounds that all students are of the same religion, (2) transformation of tolerance of values among religious students taught through learning integrated with other lessons, (3) although explicitly the values of tolerance among religious students are not taught, but the values of togetherness such as greeting, sharing something that is owned, and helping the needs of other students are taught by practicing at the same time.
Keywords: Early Childhood Education, Tolerance Values in Religion
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Solfiah, Yeni Solfiah, Devi Risma, Hukmi, and Rita Kurnia. "Early Childhood Disaster Management Media Through Picture Story Books." JPUD - Jurnal Pendidikan Usia Dini 14, no. 1 (April 30, 2020): 141–55. http://dx.doi.org/10.21009/141.10.
Full textAbstract:
Indonesia is a country that has a high potential for natural disasters. Picture story book is a form of disaster management learning that can help children from an early age to prepare for a natural disaster. The aims of this study to develop story books as a disaster management learning media, to improve knowledge and skills of children and teacher about the understanding, principles, and actions of rescue when facing the natural disasters, to increase the teacher’s learning quality in disaster management. Developmental research approach is used to execute the study. A total of 48 children aged 5-6 years have to carry out pre-test and post-test. Pre-test data shows that children's knowledge about disaster management with an average of 47.92% and its improved at post-test with 76,88%. Five theme of story books involves floods, landslides, earthquakes, tsunamis, lands and forest fires is the product. Dissemination of five story books are proper for children and improve their understanding of disaster management.
Keywords: Early Childhood Education, Management Disaster, Storybooks
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Anastasija, Sangirejeva, Azina Inga, and Rozentale Baiba. "Cryptococcosis in HIV – Infected Hospitalized Patients in Latvia." Journal of Scientific Research and Reports, August 3, 2019, 1–10. http://dx.doi.org/10.9734/jsrr/2019/v24i230149.
Full textAbstract:
Aims: To determine the prevalence of cryptococcal infection among HIV hospitalized patients, to evaluate clinical characteristics and outcomes in Latvia.
Study Design: Cross-sectional study.
Place and Duration of Study: Riga Eastern Clinical University Hospital, Latvian Center of Infectology, between January 2014 and February 2017.
Methodology: We conducted the study reporting demographics, epidemiological (age, sex, clinical aspects, paraclinical results (cryptococcal antigen in cerebrospinal fluid, serum, urine, cryptococcal DNA, HIV RNA and lymphocyte T CD4+ count), treatment and outcome aspects. We analyze 69 patients (71% men, 29% women) with HIV infection and cryptococcosis.
Results: 69 cases of cryptococcosis were confirmed for 699 HIV infected hospitalized patients tested, giving a prevalence of 9.9%. 38% (n=26/69) of patients were with clinical signs of infection with the central nervous system involvement, 19% (13/69) patients had pulmonary involvement.
Other 43% (n=30/69) of patients had disseminated non-CNS disease (elevated serum cryptococcal Ag or DNA). Most patients had advanced HIV disease (Median lymphocyte T CD4+ count=48, 5 cells/uL, (1-1041), the average was 112, 9 cells/ uL (SD 184.98). 87% (n=59/68) of patients had lymphocyte T CD4+cell count < 200 cells/μL Only 25% (n=14) of the patients known to have HIV infection (n=56/69) were receiving antiretroviral therapy at the time of presentation. Overall mortality rate was 59% (n=41/69).
Conclusion: Prevalence of cryptococcal antigenemia was 9.9%, indicating that the prevalence of cryptococcal infection among HIV patients in Latvia may be high enough to consider targeted screening.HIV positive patients have high mortality (35%) following cryptococcal infection which persists beyond their initial hospitalization. Follow-up studies of late mortality would be beneficial.
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Nwafor, Chidozie Edwin, Leonard Nnaemeka Ezeh, Paschal Chukwuma Ugwu, and Chukwuemeka Nelson Etodike. "Ethnocentrism and Global Identity as Predictors of Attitude towards Herdsmen-farmers Conflict in South-East Nigeria." Asian Journal of Advanced Research and Reports, May 8, 2019, 1–8. http://dx.doi.org/10.9734/ajarr/2019/v4i230109.
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The study examined if ethnocentrism and global identity were predictors of attitude (Positive or Negative) towards herdsmen among secondary school students of Nimbo community, Uzo-Uwani Local government Area Enugu state and Awka metropolis, Anambra state Nigeria. Two hundred and thirty-two (232) participants (male 111, 47.8%) and (female 121, 52.2%) were randomly selected from four secondary schools. Their ages ranged from 14-18 (M= 15.99, SD=1.10). Three instruments were used for data collection (Ethnocentrism Scale by Neulip & McCroskey, 2013; Global Identity Scale by Turken & Rudmin 2013 and Attitude towards Herdsmen Scale, 2018 developed in the course of this study. The study was a cross-sectional survey and Pearson correlation design was adopted while and regression statistics were used for analysis. The results showed that ethnocentrism and locality were positively and negatively related to attitude towards herdsmen respectively while global identity did not predict attitude towards herdsmen. Based on the findings, the study implicated attitudinal bias and ethnic sentiments which may be localized as a result of experiences and interactions of the group. It is therefore recommended that desensitization programs along ethnic and religious line be encouraged in areas with herdsmen attack experiences and vulnerable areas under perpetual fear of attack in order to reduce ethnic bigotry and hatred capable of inflaming reprisal attack from the community in order to promote peace and cohabitation.
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Kweh, Barry, Hui Lee, Terence Tan, Tom O’Donohoe, Joseph Mathew, Mark Fitzgerald, Dashiell Gantner, et al. "Spinal Surgery in Patients Aged 80 Years and Older: Risk Stratification Using the Modified Frailty Index." Global Spine Journal, March 30, 2020, 219256822091487. http://dx.doi.org/10.1177/2192568220914877.
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Study Design: This was an ambispective clinical quality registry study. Objective: To evaluate utility of 11-variable modified Frailty Index (mFI) in predicting postoperative outcomes among patients ≥80 years undergoing spinal surgery. Methods: Consecutive patients ≥80 years who underwent spinal surgery between January 1, 2013, and June 30, 2018, were included. Primary outcome measure was rate of major complication. Secondary outcome measures were (1) overall complication rate, (2) surgical site infection, and (3) 6-month mortality. Results: A total of 121 operations were performed. Demographic metrics were (1) age (mean ± SD) = 83.1 ± 2.8 years and (2) mFI (mean ± SD) = 2.1 ± 1.4 variables. As mFI increased from 0 to ≥4 variables, risk of major complication increased from 18.2% to 40.0% ( P = .014); overall complication increased from 45.5% to 70.0% ( P = .032); surgical site infection increased from 0.0% to 25.0% ( P = .007). There were no significant changes in risk of 6-month mortality across mFIs ( P = .115). Multivariate analysis showed that a higher mFI score of ≥3 variables was associated with a significantly higher risk of (1) major complication ( P = .025); (2) overall complication ( P = .015); (3) surgical site infection ( P = .007); and (4) mortality ( P = .044). Conclusions: mFI scores of ≥3/11 variables were associated with a higher risk of postoperative morbidity in patients aged ≥80 years undergoing spinal surgery. The mFI-associated risk stratification provides a valuable adjunct in surgical decision making for this rapidly growing subpopulation of patients.
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Kulchetscki, R., A. P. Ferraz, F. C. Gouvea, F. K. B. Alexandre, M. P. Mayrink, A. L. M. Goncalves, V. H. Dias, et al. "Catheter ablation for ventricular tachycardia in Chagas disease." European Heart Journal 41, Supplement_2 (November 1, 2020). http://dx.doi.org/10.1093/ehjci/ehaa946.0759.
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Abstract Background Chagas disease (ChD) is a major cause of non-ischemic cardiomyopathy (NICM) in Latin America and is becoming more frequent in other parts of the world, especially due to immigration movements. Ventricular Tachycardia (VT) is more common in this type of NICM than others, and finding an effective treatment strategy still is a challenge. Catheter ablation is an option, but there is poor data regarding its efficacy and safety. Purpose Evaluate the outcomes after VT catheter ablation in ChD patients. Methods Data were collected by VT studies reports and patient record analysis, including comorbidities and clinical status at baseline and on follow-up. We analyzed all-cause mortality, one-year VT recurrence rate and procedure related major complications. Results Between January 2013 and December 2018, 157 catheter ablation procedures in 121 ChD patients were performed in our institution. The mean follow-up time was 22.6±22.1 (mean ± SD) months. Overall post procedure mortality was 33.1%, and mean survival time was 51.2 months (95% CI: 44.8–58. NYHA functional class (p=0.022), ejection fraction (p=0.020) and immediate ablation result (p 0.002) were predictors of all-cause mortality in the follow-up. Clinical VT inducibility after ablation was a predictor of VT recurrence at one year (p=0.04). An epicardial approach was performed in 125 (79%) procedures, and accidental right ventricle (RV) puncture occurred in 23 (18.4%), in which open-chest surgery for bleeding hemostasis was necessary in 4 procedures (3.2%). Conclusion Mortality and recurrence rates in ChD patients after VT ablation were high, and correlated with heart failure severity. Epicardial approach is often necessary in this subset of patients. There was a correlation between immediate ablation results and recurrence. Kaplan-Meier of cumulative survival Funding Acknowledgement Type of funding source: None
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Hellman, Tapio, Markus Hakamäki, Roosa Lankinen, Niina Koivuviita, Jussi Pärkkä, Petri Kallio, Tuomas Kiviniemi, K. E. Juhani Airaksinen, Mikko J. Järvisalo, and Kaj Metsärinne. "Interatrial block, P terminal force or fragmented QRS do not predict new-onset atrial fibrillation in patients with severe chronic kidney disease." BMC Cardiovascular Disorders 20, no. 1 (October 7, 2020). http://dx.doi.org/10.1186/s12872-020-01719-3.
Full textAbstract:
Abstract Background The prevalence of left atrial enlargement (LAE) and fragmented QRS (fQRS) diagnosed using ECG criteria in patients with severe chronic kidney disease (CKD) is unknown. Furthermore, there is limited data on predicting new-onset atrial fibrillation (AF) with LAE or fQRS in this patient group. Methods We enrolled 165 consecutive non-dialysis patients with CKD stage 4–5 without prior AF diagnosis between 2013 and 2017 in a prospective follow-up cohort study. LAE was defined as total P-wave duration ≥120 ms in lead II ± > 1 biphasic P-waves in leads II, III or aVF; or duration of terminal negative portion of P-wave > 40 ms or depth of terminal negative portion of P-wave > 1 mm in lead V1 from a baseline ECG, respectively. fQRS was defined as the presence of a notched R or S wave or the presence of ≥1 additional R waves (R’) or; in the presence of a wide QRS complex (> 120 ms), > 2 notches in R or S waves in two contiguous leads corresponding to a myocardial region, respectively. Results Mean age of the patients was 59 (SD 14) years, 56/165 (33.9%) were female and the mean estimated glomerular filtration rate was 12.8 ml/min/1.73m2. Altogether 29/165 (17.6%) patients were observed with new-onset AF within median follow-up of 3 [IQR 3, range 2–6] years. At baseline, 137/165 (83.0%) and 144/165 (87.3%) patients were observed with LAE and fQRS, respectively. Furthermore, LAE and fQRS co-existed in 121/165 (73.3%) patients. Neither findings were associated with the risk of new-onset AF within follow-up. Conclusion The prevalence of LAE and fQRS at baseline in this study on CKD stage 4–5 patients not on dialysis was very high. However, LAE or fQRS failed to predict occurrence of new-onset AF in these patients.
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Medina, Thiago, Carlos Eduardo Sandrim Longato, Amanda Oliva Spaziani, Raissa Silva Frota, Luis Carlos Spaziani, Pedro Augusto Izidoro Pereira, Patrícia Michelassi Carrinho Aureliano, and Flávio Henrique Nuevo Benez dos Dos Santos. "Pseudoartrose em fêmur após politrauma com fratura exposta e infecção: relato de caso." ARCHIVES OF HEALTH INVESTIGATION 8, no. 12 (June 29, 2020). http://dx.doi.org/10.21270/archi.v8i12.4704.
Full textAbstract:
O politraumatizado é definido como paciente apresentando lesões traumáticas em diferentes sistemas com comprometimento potencial das funções vitais. A intervenção correta aumenta as chances de sobrevivência, reduzindo o risco de lesões secundárias. Paciente feminina, 36 anos, vítima de acidente motociclistico com lesão de nervo radial, fratura de úmero, cotovelo, primeiro, segundo e terceiro metacarpos direitos e supraintercondiliana de fêmur direito. Foi encaminhada ao centro cirúrgico para lavagem, desbridamento da fratura exposta e tração esquelética, além da tala em membro superior. Sete dias após, foi realizado procedimento cirúrgico em úmero, cotovelo e fêmur direito. Durante o procedimento, visualizou-se e se reparou um aneurisma de artéria femoral. Em coxa direita, que evoluiu com aumento de volume e dor, fez-se punção aspirativa onde se visualizou um hematoma. Depois de dois anos, realizou-se procedimento cirúrgico com enxerto artificial e estabilização, que evoluiu com secreção purulenta e antibioticoterapia. Sem sinais de consolidação, executou-se novo procedimento com enxerto autólogo e troca do material de síntese, além de nova cultura e antibiograma: assim, foi constatado Staphylococcus epidermidismultirresistente sensível a Teicoplanina. Atualmente, a paciente apresenta consolidação da fratura, ausência de infecção, ganho de força, arco de movimento limitado e encurtamento de membro. Nessa linha, os politraumas ortopédicos resultam em procedimentos hospitalares, internação e reabilitação, cujos custos associados são altos. Portanto, há necessidade de planejamento de ações preventivas e políticas de saúde na área.Descritores: Fraturas do Fêmur; Fixação de Fratura; Pseudoartrose.ReferênciasAlbino RM, Riggenbach V. Atendimento hospitalar inicial ao politraumatizado. ACM Arq catarin med. 2004;33(3):18-22.Espinoza JM. Atención básica y avanzada del politraumatizado. Acta méd peruana. 2011; 28(2):105-11.Santos MAS, Santos LGE, Oliveira GFSM, Miranda LN. Assistência de enfermagem ao paciente politraumatizado. Ciênc Biol Saúde UNIT. 2018;4(2):11-22.Sousa AN, Paiva JA, Fonseca S, Raposo F, Valente L, Duarte F, et al. Citocinas e moléculas de adesão na avaliação de politraumatizados graves: efeito do damage control orthopedics no outcome. Rev Port Ortop Traum. 2013; 21(2):121-45.American College of Surgeons. Advanced Trauma Life Support ATLS: Student course manual. 9th ed. Chicago, IL: American College of Surgeons Committee on Trauma; 2013.Oliveira NS. Pseudo-artrose. Rev Med (São Paulo). 1940;24(80):77-86.Silva AVS, Silva LABAL, Cabral KTSR, Sbruzzi IC, Andrade GP, Silva VA. Intervenção cirúrgica tardia em pseudoartrose diafisária de fêmur: relato de caso. J Health Sci. 2016;18(3):206-9.Schoeller SD, Bonetti A, Silva GA, Rocha A, Gelbcke FL, Khan P. Características das vítimas de acidentes motociclisticos atendidas em um centro de reabilitação de referência estadual do Sul do Brasil. Acta Fisiátr. 2011;18(3):141-45.Giglio PN, Cristante AF, Pécora JR, Helito CP, Lima ALLM, Silva JS. Avanços no tratamento das fraturas expostas. Rev Bras Ortop. 2015;50(2):125-30.Morales Wong MM, Padilla HL, Telo CR, Montoro PL. El control de daños ortopédicos en el paciente con lesiones complejas. Rev Med Electrón. 2010;32(2).
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Setijanto, Darmawan. "Guest Editorial." Acta Medica Philippina 53, no. 5 (October 10, 2019). http://dx.doi.org/10.47895/amp.v53i5.109.
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Dental caries is one of the major health problems in Indonesia. Data from Indonesian Basic Health Research in 2013, 2015 and 2018 showed a consistent increase in the prevalence of dental caries in 12-year-old schoolchildren: 43.4%, 53.2%, and 65.5%, respectively. More detailed results at 5 years of age show that 67.3% suffer from severe dental caries with a number (def-t) of more than 6, but only 10% get dental treatment. To overcome this problem, sufficient number of dentist is necessary. Data from the Indonesian Medical Council shows that one dentist serves about 9000 residents, therefore, every year a total of 1700 new dentists take the Hippocratic oath to carry out health services throughout Indonesia. Other than the number of dentists, dental caries prevention programs need to be developed.1
High-tech dentistry for curative treatment such as CAD/CAM to support the installation of dental implants, veneers, root canal treatment technology, and orthodontic treatment are very attractive to dentists practicing in urban areas.2 Other than curative treatment is considered as an instant treatment, curative treatment also benefits both the patient and the dentist since it is supported by high technology and relatively easy to perform. Preventive treatment is becoming less popular and the short-term impact of the treatment is not felt.3The individual preventive treatment method is stuck to old technology that is slow to develop, while community empowerment method is stuck to conservative health education method. The advancement in information technology service is still not much help to preventive treatment.4
If there is no preventive treatment innovation, then in 2023, the prevalence of dental caries in children aged 12 years old will reach to 79.2%. It means 80 out of 100 Indonesian children in their growth and development period will suffer from dental caries and bear all the consequences of other diseases due to dental caries, such as malnutrition, growth and development disorders, and other infectious diseases.5 Dental caries during mixed dentition stage can cause disruption in arrangement of the teeth (malocclusion) and will result in disturbances in masticatory and aesthetic functions. The more severe tooth and the oral disorder will reduce the immunity and increase the susceptibility to the disease.6,7
Advances in artificial intelligence in the detection of dental caries in the oral cavity are not enough to suppress the growth of the prevalence of dental cariesVarious high technologies in the early detection of dental caries have been carried out, but the impact has not been significant. Fluorescence laser technology has been used to measure bacterial products in carious lesions (DIAGNOdent), whereas fiber-optic technology has been used to detect the initial area of demineralization, cracks, or fractures, and to provide a quantitative characterization of the caries process (Digital Imaging Trans Illumination Fiber-Optic (DIFOTI) ).8–10 Demineralization of human enamel can also be detected by quantitative light-induced fluorescence (QLF).11 Changes in electrical impedance between normal enamel and tooth structure and demineralized enamel can be measured by Electronic Caries Monitor (ECM).12In fact, high-tech tools have not been used optimally in everyday dental practice because dentists and patients are more interested in curative treatment. Surveys have shown that patients have no intention to maintain their dental health routinely and continuously. Dental caries is considered a temporary disease that can heal itself or with the help of a dentist. Dental caries is considered not a serious threat to general health.
Technological advances in efforts to prevent dental disease have not been enough to suppress the growth of the prevalence of dental cariesFluoride is believed to be able to prevent dental caries by inhibiting the demineralization of the crystal structure in the teeth and increase remineralization. The enamel surfaces that are mineralized with fluoride are more resistant to acid attack.13,14 Topographic occlusal fissures of teeth are more susceptible to dental caries because of the contours that are more likely a place for plaque accumulation. This occlusal fissure conditions can be protected by filling the fissure with flowing composite material so that the surface of the occlusal becomes morphologically stronger. Xylitol and Sorbitol have been developed to be used as sugar substitutes to reduce the risk of caries. It prevents the sucrose molecule from binding to Streptococcus mutans, thus inhibiting metabolism.15 Sorbitol also reduces the ability of adhesion and the number of Streptococcus mutans. Since dental caries is an infectious microbiological disease, vaccine technology has also been applied in the prevention of dental caries. Experimental studies have succeeded in strengthening the effectiveness of vaccines against Streptococcus mutans.16 The form of the vaccines is protein, recombinant or synthetic peptides, protein-carbohydrate conjugates, as well as DNA-based vaccines. However, none of these vaccines appear on the market due to difficulties in inducing and maintaining high levels of antibodies in oral fluids. Current research is still ongoing for clinical applications.
The prevention of dental caries is not possible to be done effectively if understanding the risks and benefits of dental caries prevention, the norm of dental maintenance in the community, and the ease of its implementation are still not integrated to raise the awareness of the community and dental service providers. Evidence-based dentistry regarding the prevention of dental and oral diseases in the community as well as in private clinic and hospital settings need to be socialized. Research that emphasizes the development of basic biological sciences in efforts to prevent dental caries is absolutely necessary, as well as clinical application research and evidence-based effectiveness of drugs or materials for dental caries prevention must be developed.17 Likewise, community empowerment research to improve the mindset of preventing oral and dental diseases, norms of dental prevention in the community, and the presence of facilities and methods need to be deepened and supported with adequate artificial intelligence technology.
It can be concluded that: Research in Regenerative Dentistry, Clinical and Evidence-based Dentistry, and Dental Public Health and Primary Health Care will direct the promotion of promotive, preventive, curative and rehabilitative treatment for effective efforts to prevent dental caries and its consequences.
Dr. Darmawan Setijanto, drg., M.Kes. (DDS., MPH)Dean of Faculty of Dental Medicine, Universitas Airlangga
REFERENCES1. National Institute of Health Research and Development of Ministry of Health Indonesia. Main Result of Basic Health Research 2018.; 2018.2. Sriram S, Shankari V, Chacko Y. Computer Aided Designing / Computer Aided Manufacturing in Dentistry ( CAD / CAM ) – A Review. Int J Curr Res Rev. 2018;10(20):20-24.3. Bennadi D, Reddy V, Thummala NR. Preventive and curative measures adopted by dentists to combat occupational hazards – a cross sectional study Innovare Preventive And Curative Measures Adopted by Dentists to Combat Occupational Hazards – A Cross Sectional Study. Int J Pharm Pharm Sci. 2016;7(10):415-418.4. Janssens B, Vanobbergen J, Petrovic M, Jacquet W, Schols JMGA, Visschere L De. The impact of a preventive and curative oral healthcare program on the prevalence and incidence of oral health problems in nursing home residents. PLoS One. 2018:1-13.5. Sicca C, Bobbio E, Quartuccio N, Nicolò G, Cistaro A. Prevention of dental caries : A review of effective treatments. J Clin Exp Dent. 2016;8(5):604-610. doi:10.4317/jced.528906. Rapeepattana S, Thearmontree A, Suntornlohanakul S. Etiology of Malocclusion and Dominant Orthodontic Problems in Mixed Dentition: A Crosssectional Study in a Group of Thai Children Aged 8–9 Years. J Int Soc Prev Community Dent. 2019;9:383-389. doi:10.4103/jispcd.JISPCD7. Zou J, Meng M, Law CS, Rao Y, Zhou X. Common dental diseases in children and malocclusion. Int J Oral Sci. 2018;( January):1-7. doi:10.1038/s41368-018-0012-38. Ahlund K, Holbrook WP, Verdier B De, Tranæus S. Approximal Caries Detection by DIFOTI : In Vitro Comparison of Diagnostic Accuracy / Efficacy with Film and Digital Radiography. Int J Dent. 2012;2012:1-8. doi:10.1155/2012/3264019. Kouchaji C. Comparison between a laser fluorescence device and visual examination in the detection of occlusal caries in children. Saudi Dent J. 2012;24(3-4):169-174. doi:10.1016/j.sdentj.2012.07.00210. Gimenez T, Braga MM, Raggio DP, Deery C, Ricketts DN, Mendes FM. Fluorescence-Based Methods for Detecting Caries Lesions : Systematic Review , Meta-Analysis and Sources of Heterogeneity. PLoS One. 2013;8(4):1-14. doi:10.1371/journal.pone.006042111. Wu J, Donly ZR, Donly KJ, Hackmyer S. Demineralization Depth Using QLF and a Novel Image Processing Software. Int J Dent. 2010:1-7. doi:10.1155/2010/95826412. Bansode P V, Pathak SD, Wavdhane MB, Kale D. Diagnosing Dental Caries : An Insight. J Dent Med Sci. 2018;17(7):17-23. doi:10.9790/0853-170707172313. Kanduti D, Sterbenk P, Artnik B. Fluoride : A review of Use and Effects on Health. Mater Sociomed. 2016;28(2):133-137. doi:10.5455/msm.2016.28.133-13714. Chen F, Wang D. Novel technologies for the prevention and treatment of dental caries : a patent survey. Expert Opin Ther Pat. 2011;20(5):681-694. doi:10.1517/13543771003720491.Novel15. Shwetha R, Vivek S. Effect of dentifrices containing sorbitol , combination of xylitol and sorbitol on salivary Streptococcus mutans and Lactobacillus counts in 14-15 year old children : a randomized trial. Int J Clin Trials. 2017;4(4):184-190.16. Arora B, Setia V, Kaur A, Mahajan M, Sekhon HK, Singh H. Dental Caries Vaccine : An Overview. Indian J Dent Sci. 2018:121-125. doi:10.4103/IJDS.IJDS17. Santosh HN, Nagaraj T, Bose A, Sinha P, Mahalaksmi IP. Evidence-based dentistry : A new dimension in oral health. J Adv Clin Res Insights. 2014;1:114-119. doi:10.15713/ins.jcri.29