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1
Platonov, D. Yu, and S. N. Bel'diev. "Arterial hypertension management in patients over 80 years old: comment on the position agreement of the Russian experts." "Arterial’naya Gipertenziya" ("Arterial Hypertension") 24, no. 6 (January 26, 2019): 646–53. http://dx.doi.org/10.18705/1607-419x-2018-24-6-646-653.
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The article discusses four statements of the position agreement of the Russian experts on the treatment of arterial hypertension in patients over 80 years old, as well as in patients with senile asthenia. These statements consider recommendations on the threshold and target blood pressure levels, on the initial antihypertensive therapy (monotherapy or combination therapy), the initial doses of the drugs (low or high) in patients over 80 years old with or without senile asthenia. The authors believe that these statements require some correction as they do not fully correspond to the results of the HYVET trial. The level of evidence and recommendation class stated in the position agreement are disputable and give rise to doubt. The authors compare the position agreement by the Russian experts and European guidelines 2013 and present the evidence of the large randomized clinical trials and meta-analyses.
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Lemez, Petr, Jirina Galikova, Kyra Michalova, Alan MacWhannell, Zuzana Zemanova, and Jan Stejskal. "Standard Dose Chemotherapy 3+7 Induces Complete Remission in Patients Over 80 Years Old with Single-Lineage Acute Myeloid Leukemias and Normal Karyotype." Blood 112, no. 11 (November 16, 2008): 4006. http://dx.doi.org/10.1182/blood.v112.11.4006.4006.
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Abstract Survival of elderly patients with de novo acute myeloid leukemia (AML) is poor. A single published study on patients with AML aged 80 years and above (DeLima et al., Br. J. Haematol.1996; 93: 89) concluded that chemotherapy was not indicated since median overall survival (OS) of 29 treated patients was 1 month, 9 patients reached complete remission (CR) of 3 months median duration, and only two survived over 1 year: for 15.5 and >18 months. The aim of our study was to identify the characteristics of elderly AML patients who may reach CR by standard chemotherapy. We analyzed 9 consecutive patients with de novo AML aged 80–90 (median 83) years treated by us in 1992–2007. All bone marrow films were hypercelullar with 48–92 (median 80) % leukemic cells, classified as FAB types: 2 M2, 6 M4, and 1 M5. Six patients, all with hypertension and five with ischaemic heart disease (IHD), received chemotherapy, while 3 patients (82–87 years old) opted for supportive or palliative therapy and survived 1–4 months. Cytosine arabinoside (Ara-C) 100 mg/sqm/12 h in 3-h infusion for 7 days and 3 doses of daunorubicin (DNR) 45 mg/sqm/d i.v. (D+A, 1 case) or mitozantrone (MTZ) 10 mg/sqm/d i.v. (M+A, 3 cases) was given to 4 patients. The remaining two patients received D+A with thioguanine (TG) 100 mg/sqm/12 h p.o. for 7 days (TAD). Their WHO performance status (PS) was 4x PS3, 1x PS2, 1x PS1, and median WBC 58 (17.9–97.8) × 10^9/L. Three patients with AML M4 and normal karyotype reached CR. Maintenance therapy consisted of 4-day courses administered in intervals of 5–12 (median 8) weeks according to the patient’s clinical status and tolerance until relapse. Courses containing Ara-C 60 mg/sqm/12h s.c. with TG 70 mg/sqm/12h p.o. were repeated 3x. The fourth course was 1+4 containing a single dose DNR or MTZ as described and Ara-C. The outcomes: An 85 year-old female with IHD and LVEF 25 % reached CR with TAD. She was on maintenance in CR for 17 months when severe heart arrhythmia developed. She refused a pacemaker implantation and died 3 days later. Her OS was 18.6 months. An 80 year-old male reached CR with M+A and was on maintenance therapy when relapsed after 19.7 months. He refused further chemotherapy and his OS was 28 months. An 80 year-old female (PS1, Flt3-ITD neg.) reached CR after D+A 3+7 and got one cycle D+A 2+5 without further maintenance. Her CR lasted 10.1 months. She was further treated with 2 cycles of low-dose Ara-C and her OS was 16.5 months. Three other patients, two with normal karyotype, did not reach CR after chemotherapy. A 90 year-old male with AML M4 died of mycotic pneumonia on the 24th day of TAD induction. An 83 year-old male with AML M5, PS2, experienced nonQ myocardial infarction after M+A induction and did not reach CR. He was further treated with hydroxyurea with OS of 2.7 months. An 80 year-old female with AML M2, complex karyotype, renal insufficiency and sepsis died after 7th hemodialysis in septic shock on 10th day of M+A induction. All three patients who reached CR did not exhibit dysplasia in erythroblastic or megakaryocytic lineage showing that only granulocyte-macrophage lineage was involved in the leukemic clone (single–lineage AMLs). In contrast, all 3 patients who did not reach CR exhibited megakaryocytic dysplasia in a half or more of megakaryocytes and two had erythroblastic dysplasia in more than 26% erythroblasts. They represent a different biological category of AMLs with multi-lineage involvement. In summary, we defined a biological category of single-lineage AML patients over 80 years of age who may benefit from standard dose chemotherapy in spite of their poor performance status.
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Zhdan, Viacheslav, Yevdokiia Kitura, Maryna Babanina, Oksana Kitura, and Maksym Tkachenko. "Elderly Patient with Hypertension in General Practice: Clinical Features and Antihypertensive Therapy." Family Medicine, no. 1 (March 31, 2021): 61–66. http://dx.doi.org/10.30841/2307-5112.1.2021.231938.
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The prevalence of arterial hypertension (AH) increases with age: among people over 60 years old this index is more than 2 times higher in the general population, 2/3 of people over 65 years old suffer from hypertension. Among patients 65–89 years old with hypertension, 2/3 patients have isolated systolic hypertension (ISAG). Features of hypertension in the elderly patients are: lability of blood pressure (BP), increasing frequency of pseudohypertension, high frequency of «white coat hypertension», decreased sensitivity of pressor factors for antihypertensive drugs, high frequency of resistant to treatment of hypertension. The new recommendations of the European Society of Cardiology for the diagnosis and treatment of hypertension emphasize 2 groups of elderly patients: 65–79 years old and ≥80 years old, which described the epidemiological features, the prevalence of risk factors for cardiovascular events, blood pressure levels for antihypertensive therapy and target blood pressure, and the recommended principles of drug therapy that are different from young and middle-aged patients. For most patients, fixed combinations are indicated as starting AGT, but monotherapy is recommended for the treatment of hypertension in very elderly patients (over 80 years old) and elderly patients over 65 years old with senile asthenia. The decreasing of blood pressure should be gradual, taking into consideration the increased risk of orthostatic reactions at this age. European and American experts recommend os first-line drugs low doses of thiazide diuretics and calcium channel antagonists (mainly dihydropyridine), which are especially indicated in isolated systolic arterial hypertension to effectively reduce the frequency of cardiovascular complications in the treatment of elderly patients with hypertension.
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Varga, Cindy, and Sarit E. Assouline. "Diffuse Large B-Cell Lymphoma in the Very Elderly, a Study of Outcome in Patients Aged 80 and Older." Blood 114, no. 22 (November 20, 2009): 1942. http://dx.doi.org/10.1182/blood.v114.22.1942.1942.
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Abstract Abstract 1942 Poster Board I-965 Introduction: The trial showing that the addition of rituximab to the CHOP regimen increases complete response (CR) rate and overall survival (OS) in elderly patients (pts) with diffuse large B-cell lymphoma (DLBCL) did not include pts over the age of 80 (Coiffier, 2002, NEJM). There is very limited data on octogenarians with DLBCL. These pts are often treated with reduced-dose therapeutic regimens, which may lead to a poorer OS (Meyer, 1995, J Clin Oncol). We were interested in examining the proportion of pts with DLBCL aged 80 and over in our institution; to characterize the determinants of their OS; to assess how many received standard therapy; and, to define which characteristics lead physicians to withhold therapy. Patients and method: A retrospective chart analysis was conducted of clinical and pathological data on all new cases of DLBCL from 2004 to 2008. Clinical data collected included International Prognostic Index (IPI), LDH, therapy received, and survival. Pathologic data included presence or absence of bcl-6 and/or bcl-2 expression, and proliferative fraction as determined by the level of Ki-67. This study received IRB approval. A Kaplan-Meier survival analysis was performed, Fisher's exact test was used to estimate p value for proportions, and confidence intervals were estimated for means. Results: We identified 54 new cases of DLBCL with a median age of 69.5 years. Fifteen pts (27.8%) were age 80 or older. Male to female ratio was 1:1.5. The average IPI was greater in pts above 80 than in pts below 80 years of age, 3.0 [95% confidence interval (CI), 2.17-3.83] vs. 1.9 [95% CI, 1.51-2.29 ], respectively. The LDH was high in 57.9% (22/38) of pts in the younger group vs. 69.2% (9/13) of pts in the older group (p=0.52). The presence of bcl-6 in the younger group versus the older group was 88.6% (31/35) and 84.6% (11/13), respectively (p = 0.65). The expression of bcl-2 in the younger group versus the older group was 55.9% (19/34) and 66.7% (8/12), respectively (p=0.73). The proportion of younger pts vs. older pts with high Ki67 (>80%) was 45.7% vs. 53.8%, respectively (p= 0.75). Thirty six pts under age 80 received RCHOP compared to 7 pts 80 years and over (97.3% vs. 50%) (p=0.0006). There did not seem to be a correlation between IPI or co-morbidity and whether pts received treatment. However, therapy tended to be offered to outpatients but withheld from patients hospitalized at time of diagnosis. Chemotherapy had to be reduced or terminated due to poor tolerance in 1 patient in the younger cohort vs. 2 pts in the older cohort. Amongst the older group who did not receive RCHOP, 6 pts (85.7%) did not receive any chemotherapy, while 1 patient received 5 cycles of RCEPP. Kaplan Meier analysis for overall survival of pts under age 80 compared to over age 80 is shown below (HR = 7.0, 95% CI [2.0 – 24.2]), (p = 0.002). All pts above age 80 who did not receive any chemotherapy died vs. 25.0% (1/4) who received full dose RCHOP, vs. 66.7% (2/3) who received reduced RCHOP. The CR rate was 88.6% (31/35) for those aged under 80 vs. 75% (6/8) for those above age 80 (p=0.31), while the relapse rate was 11.4% (4/35) vs. 25% (2/8), respectively (p = 0.31). Conclusions: Though limited, these data reveal interesting findings about pts aged over 80 with DLBCL. With our aging population, more physicians will be faced with the question of how to treat the very elderly with this diagnosis. These pts had a poorer overall survival which, in large part, can be attributed to the fact that therapy was never administered. Age above 80 and hospitalization seemed to be the only clear reasons for withholding therapy. Elderly pts tended to have higher IPIs, but did not seem to have histologically more aggressive tumours. Interestingly, the pts over the age of 80 who died did tend to have more frequent expression of bcl-2. In contrast, all elderly pts who survived were bcl-6 positive. When standard therapy is given to pts over the age of 80, their response rates do not differ from those in younger pts. Further research into pts above 80 years of age with DLBCL is needed to confirm our findings. Nonetheless, our results raise questions about how we approach treatment of DLBCL in the very elderly and suggest that age alone should not prevent standard doses of therapy from being administered. 1. Kaplan-Meier survival curves for the two age groups: Disclosures: No relevant conflicts of interest to declare.
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Sood, Gaurav, Rajesh Kaushal, Anjali Chauhan, and Shaweta Gupta. "Indigenous plant-growth-promoting rhizobacteria and chemical fertilisers: impact on wheat (Triticum aestivum) productivity and soil properties in North Western Himalayan region." Crop and Pasture Science 69, no. 5 (2018): 460. http://dx.doi.org/10.1071/cp18016.
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High levels of crop productivity cannot be sustained by chemical fertiliser application alone. In order to mitigate this, a 2-year study was conducted to test the effects of combined application of indigenous plant-growth-promoting rhizobacteria (PGPR) and chemical fertilisers on productivity of wheat and soil properties. Ten morphologically distinct indigenous PGPR isolates from wheat roots and rhizosphere were evaluated at Solan, Himachal Pradesh, India, during 2013–14. Three PGPR isolates (B2, SIR1 and BIS2) with maximum PGP traits were screened at different doses of nitrogen (N) and phosphorus (P) (80%, 60% and 40% of recommended fertiliser dose, RFD) under net-house conditions. Two isolates, B2 (Serratia sp.) and SIR1 (Bacillus subtilis), along with the optimum NP dose (i.e. 80% RFD) were selected for field experimentation, which was performed over two consecutive years, 2014–16. Combined application of 80% RDF of NP with PGPR (B2) significantly increased wheat yield by 9.4%, number of tillers per plant by 28.03%, grain number per spike by 19.61%, 1000-grain weight by 10.5%, and biomass by 9.2% relative to the uninoculated control with 100% RFD. Soil properties in the terms of available N, P and potassium, microbial biomass carbon, soil enzyme activities and population of phosphate-solubilising bacteria in the wheat crop were significantly increased by the combined application of bacterial inoculants with 80% RFD of NP in both years over the uninoculated control. Therefore, the results revealed the potential of indigenous PGPR isolates to supplement ~20% of NP fertilisers without hampering the soil fertility and productivity of wheat.
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Vorobyeva, N. M., and O. N. Kacheva. "Possibilities of Using Rivaroxaban in Elderly Patients with Atrial Fibrillation: Data from Randomized Studies and Real Clinical Practice." Rational Pharmacotherapy in Cardiology 14, no. 4 (September 4, 2018): 575–82. http://dx.doi.org/10.20996/1819-6446-2018-14-4-575-582.
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The possibility of rivaroxaban using in elderly patients with non-valvular atrial fibrillation is discussed in the review. The results of ROCKET-AF randomized trial, including subgroup analysis in patients older than 75 years, are presented. The problem of unreasonable prescription of low doses of anticoagulants in real clinical practice and questions of adherence of patients to anticoagulant therapy are discussed. The results of two recent studies of actual clinical practice performed in patients over the age of 80 and 85 years, respectively, are presented as well as favorable profile of the efficacy and safety of rivaroxaban in these age groups. Rivaroxaban reduced the risk of stroke/systemic embolism by 38% and ischemic stroke by 41% with a comparable risk of major bleeding in patients older than 80 years. In another study, in patients older than 85 years in the rivaroxaban group, a 11% reduction in the risk of death from all causes, a reduction in the risk of major bleeding by 10% and an acute coronary syndrome by 14%, with similar risk of stroke/systemic embolism, clinically significant minor bleeding and a combined endpoint (stroke/systemic embolism, large bleeding, death from all causes) have been found.
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Biswas, GC. "Comparative Effectiveness Of Neem Extracts And Synthetic Organic Insecticide Against Mustard Aphid." Bangladesh Journal of Agricultural Research 38, no. 2 (July 28, 2013): 181–87. http://dx.doi.org/10.3329/bjar.v38i2.15881.
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Effectiveness of different doses of neem extracts and a synthetic organic insecticide against mustard aphid was studied in the experimental farm of the Oilseed Research Centre, Bangladesh Agricultural Research Institute (BARI), Joydebpur, Gazipur, during two consecutive years 2010-2011 and 2011-2012 for the control of mustard aphid. Eight treatments were evaluated against mustard aphid under field condition. The maximum aphid population was (180 per plant) observed at the pod formation stage of mustard crop. Among the treatments, Malataf (Malathion 57EC) @ 2ml/l significantly reduced the highest aphid population (93.75%) over pretreatment which produced the highest seed yield (1440 kg/ha) of mustard. The neem leaf extracts reduced 63.16-72.55% aphid population in mustard while neem seed extract reduced 73-81% aphid population over pretreated plants in both the years. Among the different doses of neem extracts, the highest aphid population reduction over pretreatment (81%) was recorded from 50g neem seed per litre of water treated plots with high MBCR (3.88) followed by 75g neem seed/l treated plots having reduction of 80% and MBCR 3.78. Bangladesh J. Agril. Res. 38(2): 181-187, June 2013 DOI: http://dx.doi.org/10.3329/bjar.v38i2.15881
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Aoki, Kazunari, June Takeda, Yuki Hunayama, Nobuhiko Yamauchi, Aiko Kato, Yuichiro Ono, Hiroshi Arima, et al. "Prognostic Factors of Elderly Diffuse Large B-Cell Lymphoma Treated with R-CHOP: Performance Status and Age Over Eighty, but Neither Lactate Dehydrogenase Level, Stage, Nor Relative Dose Intensity Delivered, Associated with Clinical Outcome." Blood 118, no. 21 (November 18, 2011): 1610. http://dx.doi.org/10.1182/blood.v118.21.1610.1610.
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Abstract Abstract 1610 Introduction: As for the prognostic factors of elderly patients with diffuse large B-cell lymphoma (DLBCL) treated with R-CHOP, limited reports have been available. Although the maintenance of relative dose intensity (RDI) has been considered to improve the outcome, recent reports show that dose-reduced R-CHOP also has successful results on elderly DLBCL (Lancet Oncology. 2011; 12: 460). As rigid adherence to R-CHOP protocol is difficult in the treatment of elderly DLBCL, we investigated the relationship between RDI delivered and clinical outcomes in elderly patients with DLBCL. Method: We retrospectively analyzed a total of 109 consecutive DLBCL patients over 70 years who were diagnosed and received R-CHOP in our institution between January 2004 and January 2011. Among them, 56 % were male, and 38 % were over 80 years. 49 % of patients had an Ann Arbor stage III or IV, and ECOG performance status (PS) were >= 2 in 37 %. Lactate dehydrogenase (LDH) levels were higher than normal in 60 %. Age-adjusted IPI was 2–3 in 45 %. Charlson comorbidity index (CCI) was >= 2 in 23 %. Most patients with localized disease received 3 cycles of R-CHOP (delivered with 21-day interval) followed by radiation, and patients with advanced disease received 6 or 8 cycles of R-CHOP. In the first cycles of R-CHOP therapy, patients aged 70–79 years received 70 % dose of cyclophosphamide, adriamycin and vincristine. Patients over 80 years received 50 % dose of them. Predonisolone was also reduced to 40–60 mg on day 1–5 according to patients' condition. Thereafter, the doses were individually adjusted according to attending physicians' judgment. 78 % of the patients experienced grade 3–4 neutropenia and 21 % grade 3 febrile neutropenia. Two patients died of neutropenia and infection. 65 % of patients received prophylactic G-SCF. By using clinical records of these patients, we estimated the prognostic factors using the Cox regression model. Estimates of prognostic factors were expressed as hazard ratios (HR) and 95 % confidence interval (CI) based on the Cox regression. We did two-sided statistical tests, with a 5 % level of significance. This study was approved by our institutional review board. Result: After median follow up for living patients of 25.5 months, 41 deaths has occurred (including 22 due to lymphoma), and 2-year overall survival (OS) and progression-free survival (PFS) were 71.3 % [95 % CI 60.8 %–79.5 %] and 53.5 % [95 % CI 42.7 –63.1 %], respectively. Univariate and multivariate analysis revealed that LDH and staging at diagnosis were not associated with prognosis. PS >= 2 (HR 2.94, 95 % CI 1.48–5.84, P=0.002) and age >= 80 years (HR 2.05, 95 % CI 1.04–4.04, P=0.039) retained independent adverse prognostic values for 2-year OS in multivariate analysis. Dividing entire population into 3 groups using these 2 prognostic factors, 2-year OS were 82.7 % (70 <= age < 80 and PS < 2), 67.3 % (70 <= age < 80 and PS>=2 or age>=80 and PS < 2), and 52.5 % (age >= 80 and PS >= 2), respectively (log-rank, P=0.0004). Among the all 109 patients, 91 patients received >=3 cycles of R-CHOP and RDI could be calculated. RDI was strongly associated with age (R-squared 0.42, RDI (%) = 201-1.90x age (years)). When high age-adjusted RDI group (H-aaRDI) was defined as the group of patients who satisfied □eRDI > 201 - 1.90x age', and low age-adjusted RDI group (L-aaRDI) as □eRDI< 201 - 1.90x age', 2-year OS were equivalent between H-aaRDI and L-aaRDI groups (79.8 % vs 78.7 %, log-rank, P=0.36). When multivariate analysis was performed against those 91 patients, 2-year OS was also independently associated with PS >=2 (HR 3.12, 95 % CI 1.35–7.20, P=0.008) and age >=80 (HR 2.41, 95 % CI 1.04–5.59, P=0.041). Lower age-adjusted RDI did not have prognostic value (HR 1.28, 95 % CI 0.55 – 2.94, P=0.57). Conclusion: Our retrospective analysis confirmed the efficacy of reduced-dose R-CHOP against elderly DLBCL, as was reported previously. Their prognosis was not associated with LDH level, staging, nor RDI delivered, but with ECOG PS and age over 80. Our findings indicated that strict adherence to keep RDI may not be necessary in the treatment of elderly DLBCL. The simple method to define optimal dose of R-CHOP for elderly should be explored. Disclosures: No relevant conflicts of interest to declare.
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Lauseker, Michael, Roman Gerlach, Martin Tauscher, and Joerg Hasford. "Female and Elderly Chronic Myeloid Leukemia Patients Often Do Not Receive an Adequate TKI Treatment." Blood 128, no. 22 (December 2, 2016): 3101. http://dx.doi.org/10.1182/blood.v128.22.3101.3101.
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Abstract Introduction For one and a half decade, tyrosine kinase inhibitors (TKI) have been the standard treatment for Philadelphia chromosome-positive chronic myeloid leukemia (CML). Recent studies have shown that elderly patients above 65 years benefit from a TKI treatment too. Since there were sporadic reports that elderly CML-patients receive less often TKI the aim of our study was to determine if the prescribing of TKI for CML in Germany follows the current recommendations, especially in the elderly. This was done by analyzing population-based claims data from the Bavarian Association of Statutory Health Insurance Physicians (Kassenärztliche Vereinigung Bayerns). Methods Data on ICD-10 codes as well as prescribed medication were available for about 10.5 million patients in the statutory health insurance system in Bavaria for the years 2008 to 2013. To avoid misclassification, only patients with at least two recorded diagnoses of CML over time were counted. All analyses on daily doses of TKI in this work are based on the daily doses recommended by the EMA, i.e. 400 mg/d for imatinib, 100 mg/d for dasatinib, 300 mg twice/d for nilotinib, 500 mg/d for bosutinib and 45 mg/d for ponatinib. Analyses were performed with R 3.1.0 and SPSS 22. Results 1880 different CML patients were identified between 2008 and 2013. During the six years analysed, 1,431,882 daily doses of TKI were administered. The majority of TKI doses were imatinib with 1,204,025 daily doses (84%), followed by nilotinib with 145,291 daily doses (10%) and dasatinib with 81,818 daily doses (6%). The percentage of CML patients receiving TKI increased from 55% in the first quarter year of 2008 to 72% in the last quarter year of 2013. 1534 patients were observed for at least four quarter years between 2008 and 2013. At median, they received 64 doses of TKI per quarter year. 1209 patients (78.8%) were treated with TKI. Only 711 patients (46.3%) received more than 67.5 daily doses, thereof 71 (4.6%) with more than 100 daily doses per quarter year. The latter are supposed to be patients with a high-dose imatinib treatment. Out of the 325 patients that did not receive any TKI, 293 (90.2%) were treated with Hydroxyurea, only 14 patients (4.3%) received Interferon. When stratifying for age group and sex, we found that for the males, the median number of daily doses in patients that actually received TKI sank from 88 doses per quarter year for patients younger than 20 years to a median of 72 daily doses for patients of 80 years and older. For women the median number of daily TKI doses was generally lower than for men. Here the highest median number of daily doses per quarter year was reached between 50 and 69 years with 80 doses and decreased to 58 in the oldest patients. However, the percentage of patients that did not receive any TKI increased steadily with age. While all patients below 20 years received TKI, 46% of the males and 43% of the women in the oldest age group of 80 years and above did not get any TKI treatment. In total, 429 (28.0%) of the patients received any second-generation TKI. The use of second-generation TKI did not depend on age or sex. Discussion Our analyses have shown, that even in the most prosperous part of a highly developed country with an extensive statutory health insurance system, still a considerable number of CML patients did not receive the adequate treatment. We found that especially elderly patients were often treated with Hydroxyurea only. There might be various reasons, as especially elderly patients might suffer from other malignancies, but also an underestimation of the patient's remaining life expectancy by the physician, resulting in withholding the expensive treatment to the elderly. Besides, it was noteworthy that women received a lower median dose than men. As it has been repeatedly shown that too low doses of treatment with TKI are accompanied with less therapeutic success, patients and physicians need to be motivated to take more care for administering the required doses over time. It has been shown that this may even be cost effective as poor adherence with TKI treatment results in higher health care costs. Disclosures No relevant conflicts of interest to declare.
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Ajjan, Nour, and Sian Shenton. "COMPARING ORAL PARACETAMOL DOSES IN PAEDIATRICS WITH THE NEW BNF-C DOSING." Archives of Disease in Childhood 101, no. 9 (August 17, 2016): e2.8-e2. http://dx.doi.org/10.1136/archdischild-2016-311535.16.
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The BNF-C 2014–20151 highlighted some key changes to the dosing of paracetamol in paediatrics, including a change in maximum daily dosage of oral paracetamol from 90 mg/kg/day to 75 mg/kg/day for post-operative pain, and inclusion of age-banded dosing for pain and pyrexia.The local Trust Paediatric Acute Pain Management Manual2 has acknowledged this change, but advised a maximum daily dose of 80 mg/kg/day. This audit was undertaken to determine whether national proposed changes were implemented in practice, in comparison with local guidelines.AimsThe aims and objectives of the audit were to compare oral paracetamol dosing in both medical and surgical settings with the new BNF-C dosing.MethodData were collected over a two week period in September 2014, from two medical and two surgical paediatric wards. The criteria for data collection included paediatric patients above the age of one month and up to 18 years, prescribed oral paracetamol for pain or pyrexia.The following data were collected:▸ Initials of patients and age (for identification purposes and to prevent duplications)▸ Weight (to assess appropriate and safe prescribing)▸ Reason for admission (to distinguish between medical and surgical settings).ResultsData were collected from 24 medical and 48 surgical patients (age range 1 month–16 years).The key findings were:19/24 medical patients were dosed according to the BNF-C age banded guidelines; 5/24 were dosed according to weight: 3 followed the Trust Manual; 1/24 followed the BNF-C, and 1 miscellaneous. No patients had a dose exceeding 80 mg/kg/day.87% of surgical patients were dosed according to the weight based calculation, 69% of whom were within the maximum daily dose of 75 mg/kg. Of the 31% whose daily dose exceeded 75 mg/kg, all were less than 80 mg/kg/day.The Trust Pain Manual does not include the dose banding as per the BNF-C but recommends 20 mg/kg 6 hourly (max 80 mg/kg/day) for acute pain in this age group.ConclusionChildren on the medical wards were prescribed paracetamol following age banded dosing as per BNF-C, whereas surgical wards were more likely to dose by weight following the Trust Pain Manual.The Trust Pain Manual differs from the BNF-C and recommends a maximum daily dose of 80 mg/kg/day for acute severe pain, to ensure adequate pain control and minimise calculation errors. Despite the new guidance in the BNF-C, it was found that many patients were prescribed a maximal daily dose greater than 75 mg/kg/day; however no patient's daily dose exceeded 80 mg/kg/day as indicated in the Manual.The main finding from the audit was that prescribers were not aware of the change in maximal daily dose of oral paracetamol. To highlight this important point, a poster was designed and distributed amongst the medical and surgical staff on the wards, highlighting that the dose should not exceed 75 mg/kg in a 24 hour period.
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Arriaga, Yull Edwin, Bedda L. Rosario, Elisabeth Scheufele, Amol Rajmane, Brett South, Sarah Kefayati, Judy George, Timothy Bullock, Gretchen Purcell Jackson, and Kyu Rhee. "Complete human papillomavirus vaccination coverage over a 13-year period in a large population of privately insured U.S. patients." Journal of Clinical Oncology 38, no. 15_suppl (May 20, 2020): 1511. http://dx.doi.org/10.1200/jco.2020.38.15_suppl.1511.
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1511 Background: In the US, Human Papillomavirus (HPV) vaccination coverage is low, particularly in adolescents aged 13-15 years with respect to the Healthy People 2020 goal of 80%. There has been variability in the definition of measuring vaccination coverage in published studies. We examined complete HPV vaccination coverage in a population of privately insured individuals in the US. Methods: This retrospective study used IBM MarketScan Commercial Database, years 2006 to 2018. Inclusion criteria were ages 9 to 45 years and continuous enrollment from age 9 years or from 2006. Complete HPV vaccination coverage was defined as receipt of 2 doses (age 9-15 years) or 3 doses (age 16-45 years) within 12 months and stratified by year, demographics, and US region. Mean vaccination costs per dose were summarized by vaccine brand and health plan type. Results: The table summarizes complete HPV vaccination coverage by selected age groups for 2006 (n=12,221,938), 2010 (n=4,692,633), 2014 (n=2,808,132), and 2018 (n=1,662,148). From 2017 to 2018, the percentage of members who received HPV vaccine increased; for females ages 13-15 by 1% and 16-17 by 5% while for males ages 13-15 by 6% and 16-17 by 15%. In 2018, by region, the highest coverage was in females aged 18-26 at 53% and males aged 16-17 at 43% in the Northeast, and mean cost for each brand was $120 (-6% from 2017), $165 (-3%) and $220 (+5%) for Cervarix (n=151), Gardasil (n=8,201) and Gardasil 9 (n=139,356), respectively. The rate of utilization of Gardasil 9 increased from 33% (2015) to 94% (2018) of all vaccines. The lowest mean HPV vaccine cost by health plan type and brand was with Point-of-Service (POS) and Cervarix at $106, and the highest was with POS with Capitation and Gardasil 9 at $243. Conclusions: In a commercially insured US population, complete HPV vaccination coverage was lower than the Healthy People 2020 goal, but increased over time. Coverage varied according to health plan type and by region. In 2018, Gardasil 9 had the highest mean cost but was the most utilized vaccine, which may be related to broader coverage of HPV types. This study was limited by the transient nature of member enrollment and complexity of measuring complete vaccination coverage. These results should inform policy makers and practicing clinicians about the gap in vaccination coverage. [Table: see text]
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Tambralli, Ajay, Timothy Beukelman, Peter Weiser, Thomas Prescott Atkinson, Randy Quentin Cron, and Matthew Laurence Stoll. "High Doses of Infliximab in the Management of Juvenile Idiopathic Arthritis." Journal of Rheumatology 40, no. 10 (August 15, 2013): 1749–55. http://dx.doi.org/10.3899/jrheum.130133.
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Objective.To review our experiences with high-dose infliximab (IFX) to treat juvenile idiopathic arthritis (JIA). We routinely use high doses of IFX (10–20 mg/kg) in children with recalcitrant or highly active JIA. Although biologics have revolutionized treatment of JIA, many patients have active disease despite therapy. Studies have shown benefits of high-dose IFX in several conditions, including inflammatory bowel disease, psoriasis, and idiopathic uveitis. The safety and effectiveness of high-dose IFX have not been evaluated in JIA.Methods.We performed a retrospective review of children with JIA who received IFX ≥ 10 mg/kg. We recorded all serious adverse events (SAE), medically important infections, and infusion reactions. We also recorded the physician global assessment of disease activity (MD global) and active joint count (AJC) at initiation of high-dose IFX and 3, 6, and 12 months thereafter.Results.Fifty-eight subjects received a total of 1064 infusions over 95 person-years. There were a total of 9 SAE (9.5/100 person-yrs), 7 of which were potentially related to therapy, and 6 infusion reactions (0.5%), none constituting anaphylaxis. Statistically significant improvements were observed in the AJC (median 0, range 0–31, vs 2, 0–39) and MD global (12, 2–31, vs 22, 5–80) over the first year.Conclusion.High-dose IFX appears safe in the management of JIA. Future prospective controlled studies are necessary to evaluate its safety and efficacy.
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Zuckerman, Tsila, Ruth Ben Yakar, Stela Gengrinovitch, Ron Hoffman, Israel Henig, Noa Lavi, Luiza Akria, et al. "Astarabine, a Pro-Drug of Cytarabine, Is Safe for Patients with Advanced Acute Leukemia. A Phase I/IIa Single Center Study in Relapsed/Refractory or Medically Unfit Patients." Blood 126, no. 23 (December 3, 2015): 3810. http://dx.doi.org/10.1182/blood.v126.23.3810.3810.
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Abstract Introduction: Therapy of acute leukemia has not changed significantly over the years. Both acute myeloid leukemia (AML) and acute lymphocytic leukemia (ALL) typically present or have a second peak in older adults, which often precludes intensive therapy due to associated comorbidities. Astarabine, a construct of cytarabine covalently bound to asparagine, is a pro-drug specifically targeting leukemic blasts which are dependent on an external source of asparagine. Within the blasts, Astarabine is cleaved to cytarabine enabling targeted killing and relative sparing of normal hematopoiesis. As such, Astarabine may serve as an ideal therapy for leukemia and, particularly, for medically unfit/older adults otherwise given only supportive therapy. Additionally, targeted killing by Astarabine may be more efficacious and can lead to improved responses in relapsed/refractory patients. The aim of this study was to evaluate the safety and optimal dose of Astarabine in refractory/relapsed or medically unfit patients with acute leukemia. Methods: This prospective open label study enrolled patients >18 years of age with relapsed/refractory acute leukemia or those unfit for intensive therapy, as judged by the treating physician. Refractory acute leukemia was defined as a failure to achieve remission following the last administered treatment. Relapsed disease was defined as recurrence after induction and consolidation. The study was approved by the Rambam IRB. Patients were enrolled into 4 Astarabine escalating dose cohorts, each composed of 3 patients. Treatment was administered as a 1-hour single daily infusion for 6 days. Astarabine doses for each infusion, measured as an equivalent to cytarabine dosing, for age ≤50 years were: 0.5g/m2, 1.5g/m2, 3g/m2 and 4.5g/m2. Astarabine doses for age >50 years were reduced by 50%. Results: The outcome of the first 3 cohorts (9 patients) is reported herein (table 1). Eight patients had AML, of whom 4 had refractory/relapsed and 4 had newly diagnosed secondary AML unfit for intensive therapy, while 1 patient had newly diagnosed ALL. Median age was 80 years (range 27-90). Four patients are alive with a follow-up of 1-10 months, 2 of whom are in continuous CR 4 and 6 months after treatment. Three patients died from disease progression; one died suddenly 7 days after treatment, an event not judged to be treatment-related. No significant adverse events were recorded during or after therapy apart from neutropenic fever. Conclusions: Astarabine, a pro-drug of cytarabine, is safe and very well tolerated, including patients over 80 years of age, and resulted in complete remission in 3 of 9 patients with acute leukemia. Further dose escalation studies are currently ongoing at a cytarabine-equivalent dose of 4.5 g/m2. A phase II study is planned to confirm these encouraging results and define the use of Astarabine for patients otherwise unable to receive high doses of cytarabine. Table 1. Patient No. Age in years Diagnosis BM blasts after treatment Outcome Follow-up duration in months Day 14 Day 30 1 75 Refractory AML 90% 83% Died- DP 3 2 81 Refractory AML 64% 70% Died - DP 2 3 27 Refractory AML 37% 60% Alive with disease 6 4 76 Secondary AML 39% 63% Died -DP 4 5 81 Secondary AML 5% 0% Alive in CR 6 6 63 Refractory AML 100% 100% Died -DP 1 7 90 ALL 3% 0.2% Alive in CR 4 8 86 Secondary AML 80% 8% Alive in PR 3 9 80 Secondary AML N/A N/A Died 1 DP: disease progression; PR: partial remission; CR: complete remission; N/A: non-applicable Disclosures Off Label Use: Astarabine, a Pro-Drug of Cytarabine. A noval therapy for acute leukemia. Ben Yakar:BioSight Ltd.: Employment, Equity Ownership. Gengrinovitch:BioSight Ltd.: Employment, Equity Ownership, Patents & Royalties.
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Pamir, M. Necmettin, Türker Kiliç, Muhittin Belirgen, Ufuk Abacioğlu, and Nural Karabekiroğlu. "PITUITARY ADENOMAS TREATED WITH GAMMA KNIFE RADIOSURGERY." Neurosurgery 61, no. 2 (August 1, 2007): 270–80. http://dx.doi.org/10.1227/01.neu.0000255519.96837.c7.
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Abstract OBJECTIVE To analyze pituitary adenoma volume changes after gamma knife radiosurgery (GKRS) in patients with 3 years of follow-up and to investigate factors that might affect these changes. METHODS Between January 1997 and March 2004, a total of 1930 patients were treated in the Gamma Knife Unit of the Marmara University Department of Neurosurgery in Istanbul, Turkey. Three hundred sixty of these patients had pituitary adenomas (PAs). This prospectively designed clinical study documents the radiological-volumetric analysis for the first 100 of these patients with PAs who had a minimum of 3 years of follow-up and met the study requirements. Each tumor was assessed with serial magnetic resonance imaging scans after radiosurgery; at each time point, adenoma volume was expressed as a percentage of the tumor's initial volume. Volume changes were investigated relative to margin dose, the cavernous sinus infiltration, and endocrinological type of adenoma. RESULTS At the end of the first year after GKRS, the PA volumes had decreased to approximately 90% of the initial volume on average. The corresponding approximate averages for the ends of Years 2 and 3 were 80 and 70% of the initial volume, respectively. At 3 years after GKRS, the PAs in the group with a peripheral dose of less than 17 Gy were reduced to approximately 80% of the initial volume on average. In contrast, the tumors in the patients with marginal doses of 21 to 23 Gy were reduced to approximately 60% of the initial volume at this stage. The adenomas treated with the highest marginal doses (>27 Gy) showed the earliest volume decreases after GKRS (6–9 mo after the procedure). Cavernous sinus noninfiltrating adenomas showed greater volume decreases after GKRS; on average, these masses were reduced to approximately 50% of their initial volume at 3 years. In contrast, the PAs that had infiltrated the cavernous sinus had only dropped to approximately 80% of their initial volume at this stage. The growth hormone-secreting PAs showed the maximum volume decrease with GKRS. On average, these lesions were approximately 60% of their initial volume at the 3-year stage. The nonfunctioning tumors and the prolactin-secreting adenomas showed similar volume changes over time. On average, these tumors had dropped to approximately 75 and 70% of the initial volume, respectively, by 3 years after GKRS. CONCLUSION Gamma knife radiosurgery halts the growth of pituitary adenomas. Cavernous sinus extension and margin dose are the most important determinants of adenoma volume after this type of therapy.
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Ditschun, Scott, Nader Soltani, Darren E. Robinson, François J. Tardif, Allan C. Kaastra, and Peter H. Sikkema. "Control of glyphosate-resistant Canada fleabane [Conyza canadensis (L.) Cronq.] with isoxaflutole and metribuzin tank mix." Canadian Journal of Plant Science 96, no. 1 (February 1, 2016): 72–80. http://dx.doi.org/10.1139/cjps-2015-0121.
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The future release of ‘Balance GT’ soybean, which is resistant to isoxaflutole and glyphosate, opens up the possibility for control of glyphosate-resistant (GR) Canada fleabane using HPPD-inhibiting herbicides (Group 27) in soybean. Field trials were conducted over two years to evaluate the dose response of an isoxaflutole plus metribuzin tank mix, as well as each chemical applied alone, to assess their response using Flint's adaptation of Colby's equation. Factorial experiments were performed in growth room and greenhouse environments to assess isoxaflutole versus glyphosate, isoxaflutole versus metribuzin, and isoxaflutole plus metribuzin versus glyphosate. Tank mixes of isoxaflutole plus metribuzin in a 1:4 ratio provided 80% control of GR Canada fleabane at a dose range between 420 (84 + 336) and 611 (122 + 489) g a.i. ha−1 at 8 WAA (weeks after application). Tank mixes achieved an 80% reduction in biomass at a dose range between 498 and 738 g a.i. ha−1, while 80% reduction in density was obtained with doses from 96 to 423 g a.i. ha−1, 8 WAA. With glyphosate as a constant tank partner, field treatments of isoxaflutole plus metribuzin were mostly synergistic with some analyses showing an additive response. When tested in the growth room, isoxaflutole plus glyphosate tank mixes indicate additivity in the majority of treatments on glyphosate-susceptible (GS) fleabane.
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McKay, Kyla A., Helen Tremlett, Scott B. Patten, John D. Fisk, Charity Evans, Kirsten Fiest, Trudy Campbell, and Ruth Ann Marrie. "Determinants of non-adherence to disease-modifying therapies in multiple sclerosis: A cross-Canada prospective study." Multiple Sclerosis Journal 23, no. 4 (July 11, 2016): 588–96. http://dx.doi.org/10.1177/1352458516657440.
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Background: Poor adherence to the disease-modifying therapies (DMTs) for multiple sclerosis (MS) may attenuate clinical benefit. A better understanding of characteristics associated with non-adherence could improve outcomes. Objective: To evaluate characteristics associated with non-adherence to injectable DMTs. Methods: Consecutive patients from four Canadian MS Clinics were assessed at three time points over two years. Clinical and demographic information included self-reported DMT use, missed doses in the previous 30 days, health behaviors, and comorbidities. Non-adherence was defined as <80% of expected doses taken. We employed generalized estimating equations to examine characteristics associated with non-adherence at all time points with findings reported as adjusted odds ratios (OR). Results: In all, 485 participants reported use of an injectable DMT, of whom 107 (22.1%) were non-adherent over the study period. Non-adherence was associated with a lower Expanded Disability Status Scale score (0–2.5 vs 3.0–5.5, OR: 1.80; 95% confidence interval (CI): 1.06–3.04), disease duration (⩽5 vs <5 years, OR: 2.23; 95% CI: 1.10–4.52), alcohol dependence (OR: 2.14; 95% CI: 1.23–3.75), and self-reported cognitive difficulties, measured by the Health Utilities Index-3 (OR: 1.55; 95% CI: 1.08–2.22). Conclusions: Nearly one-quarter of participants were non-adherent during the study. Alcohol dependence, perceived cognitive difficulties, longer disease duration, and mild disability status were associated with non-adherence. These characteristics may help healthcare professionals identify patients at greatest risk of poor adherence.
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Sud, Shelly, Pamela Lai, Katelyn Balchin, Mark Clemons, and Paul Wheatley-Price. "Chemotherapy in the oldest old: The feasibility of cytotoxic therapy in the 80+ population." Journal of Clinical Oncology 30, no. 15_suppl (May 20, 2012): 6083. http://dx.doi.org/10.1200/jco.2012.30.15_suppl.6083.
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6083 Background: The incidence of most common malignancies increases with age. As life expectancy improves globally, more elderly cancer patients will be candidates for systemic therapy. There is little data investigating chemotherapy (CT) in those over 80 – the “oldest old”. Our hypothesis is that CT in the 80+ population may be associated with significant toxicities and is therefore not feasible for many patients. Methods: A retrospective chart review was undertaken to report outcomes of patients ≥80 years old who initiated CT for solid tumors at the Ottawa Hospital Cancer Center between Nov. 2005 and Jan. 2010. Baseline data on patient demographics, cancer type and CT were collected. Primary endpoints included: rates of CT dose reduction, omission, delay and discontinuation due to toxicity, hospitalization and blood transfusion rates. Results: CT was initiated on 212 occasions (32% lung, 31% GU, 24% GI, 13% other cancer). Median age was 83 (range 80-92) and 60% of patients were male. Where data were available, 60% had a good performance score (ECOG 0-1) and 63% were current or ex-smokers. 82% had Charlson risk index scores of ≥5, 37% had ≥6 baseline medications, 18% lived alone independently. At baseline, 11% were anemic, 12% had leukocytosis, and 45% had impaired renal function (eGFR<60). Most patients had stage 4 disease (76%), were treated with palliative intent (75%) and were receiving first line CT (77%). Initial dose was adjusted in 34% of cases. Therapy was discontinued due to toxicity in 30% of cases, and 53% of patients required dose reduction, omission or delay. In 38% of cases, patients were hospitalized during their course of therapy or within 30 days thereof. Blood transfusions were required in 24%. Factors associated with risk of hospitalization included baseline number of medications ≥6 (OR 1.96, 95% CI 1.1-3.5) and baseline anemia (OR 2.55, 95% CI 1.07-6.05). Initial dose reduction at cycle 1 did not significantly affect rates of hospitalization, transfusion or CT discontinuation. Conclusions: CT in the 80+ population is associated with a significant risk of hospitalization, transfusion and discontinuation due to toxicity, even when doses are adjusted from the outset. We plan to prospectively validate these findings.
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Blackshaw, Robert E., and K. Neil Harker. "Wheat, Field Pea, and Canola Response to Glyphosate and AMPA Soil Residues." Weed Technology 30, no. 4 (December 2016): 985–91. http://dx.doi.org/10.1614/wt-d-16-00087.1.
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The tripling of glyphosate use in the Canadian prairies during the past decade has raised concerns over the possible accumulation of glyphosate and its main metabolite AMPA in soil over time and whether there could be any detrimental effects on crop production. A controlled environment study was conducted at two locations in Alberta, Canada, to determine glyphosate and AMPA soil concentrations that would injure wheat, field pea, and canola. Treatments included glyphosate acid or AMPA applied at 0, 10, 25, 100, 250, and 500 mg kg−1soil. Shoot and root biomass determinations 8 wk after emergence (WAE) indicated that shoot and root biomass of all crops progressively declined with increasing soil concentrations of glyphosate at both locations. In contrast, AMPA reduced crop shoot and root biomass at only one of two sites. Estimated soil concentrations of glyphosate causing 20% reductions in shoot and root biomass ranged from 80 to 190, 90 to 350, and 120 to 320 mg kg−1for field pea, canola, and wheat, respectively. Soil concentrations of AMPA causing 20% crop biomass reductions ranged from 40 to 70, 20 to 30, and 80 to 120 mg kg−1for field pea, canola, and wheat, respectively. Although substantial crop injury occurred in this study, it must be noted that these rates are very high in terms of field application rates that would be required to achieve these soil concentrations. Doses causing crop injury would convert to estimated glyphosate field rates ranging from 17.6 to 77 kg ha−1. Overall results indicate that even with frequent high-dose glyphosate applications over several years, the likelihood of wheat, field pea, and canola injury from soil residues is low. Nevertheless, there may be merit in greater monitoring of glyphosate and AMPA soil residues in cropping systems with high glyphosate utilization over a long time period.
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Hálfdánarson, Óskar Ö., Anton Pottegård, Einar S. Björnsson, Sigrún H. Lund, Margret H. Ogmundsdottir, Eiríkur Steingrímsson, Helga M. Ogmundsdottir, and Helga Zoega. "Proton-pump inhibitors among adults: a nationwide drug-utilization study." Therapeutic Advances in Gastroenterology 11 (January 1, 2018): 175628481877794. http://dx.doi.org/10.1177/1756284818777943.
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Background: The use of proton-pump inhibitors (PPIs) has grown worldwide, and there are concerns about increased unsubstantiated long-term use. The aim of the study was to describe the real-world use of PPIs over the past decade in an entire national population. Methods: This was a nationwide population-based drug-utilization study. Patterns of outpatient PPI use among adults in Iceland between 2003 and 2015 were investigated, including annual incidence and prevalence, duration of use, and dose of tablet used (lower versus higher), as well as the proportion of PPI use attributable to gastroprotection. Results: We observed 1,372,790 prescription fills over the entire study period, of which 95% were for higher-dose PPIs. Annual incidence remained stable across time (3.3–4.1 per 100 persons per year), while the annual prevalence increased from 8.5 per 100 persons to 15.5 per 100 persons. Prevalence increased with patient age and was higher among women than men. Duration of treatment increased with patients’ age (36% of users over 80 years remained on treatment after 1 year compared with 13% of users aged 19–39 years), and was longer among those initiating on a higher dose compared with a lower dose. The proportion of PPI users concurrently using nonsteroidal anti-inflammatory drugs decreased over the study period, while the proportion concurrently using acetylsalicylic acid, oral anticoagulants, or platelet inhibitors increased. Conclusions: In this nationwide study, a considerable increase in overall outpatient use of PPIs over a 13-year period was observed, particularly among older adults. Patients were increasingly treated for longer durations than recommended by clinical guidelines and mainly with higher doses.
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Brown, Jacques P. "Antiresorptives: Safety Concerns—Clinical Perspective." Toxicologic Pathology 45, no. 7 (October 2017): 859–63. http://dx.doi.org/10.1177/0192623317737066.
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Antiresorptive drugs, such as amino-bisphosphonates and denosumab (Dmab), have dominated osteoporosis therapies for over 20 years. Since osteoporosis is a chronic disease, antifracture therapy could continue for the rest of a patient’s life. Phase III clinical trials for antiresorptive drugs assessed relatively small patient populations for short durations and excluded up to 80% of patients who might seek osteoporosis therapy in clinical practice. Postmarketing reports based upon millions of patient-years and long-term (>5 years) clinical administration have associated some previously unknown, rare adverse events with antiresorptive use including osteonecrosis of the jaw (ONJ) and atypical femur fractures (AFFs). In the osteoporosis patient population, who receive much lower doses of bisphosphonate (BP) or Dmab, the incidence of ONJ is estimated at 0.001% to 0.01%, which is only slightly higher than that seen in the general population. AFFs are insufficiency or fissure transverse fractures originating on the lateral cortex of the subtrochanteric or diaphyseal region of the femur becoming oblique as they progress medially when complete. Incidence rates of AFF range from 1.8/100,000 per year with a 2-year BP exposure to 113/100,000 per year with BP exposure from 8 to 9.9 years. Most recent pathogenic hypotheses of these rare events will be discussed.
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Sajatovic, Martha, Daisy Ng-Mak, Caitlyn T. Solem, Fang-Ju Lin, Krithika Rajagopalan, and Antony Loebel. "Dosing patterns and medication adherence in bipolar disorder patients treated with lurasidone: a US retrospective claims database analysis." Therapeutic Advances in Psychopharmacology 6, no. 6 (October 15, 2016): 355–68. http://dx.doi.org/10.1177/2045125316672135.
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Background: The aim of this study was to describe dosing patterns and medication adherence among bipolar patients who initiated lurasidone in a real-world setting. Methods: Adult bipolar patients who initiated lurasidone between 1 November 2010 and 31 December 2012 (index period) with 6-month pre- and post-index continuous enrollment were identified from the IMS RWD Adjudicated Claims US database. Patients were grouped by starting lurasidone daily dose: 20 mg (7.1%), 40 mg (62.2%), 60–80 mg (28.7%), and 120–160 mg (2.1%). Patient characteristics were compared across doses using Cochran–Armitage trend tests. Multivariable ordinal logistic regression assessed the association between initial lurasidone dose and patient characteristics. Medication adherence was measured using medication possession ratio (MPR). Results: Of 1114 adult bipolar patients (mean age 40.6 years, 70.6% female), 90% initiated lurasidone at 40 mg or 80 mg/day (mean 51.9 mg/day). Of these, 16.2% initiated lurasidone as monotherapy. Mean lurasidone maintenance dose was 55.2 mg/day and mean MPR was 0.53 [standard deviation (SD) = 0.34] over the 6-month follow up. Substance use, hyperglycemia, obesity, and prior antipsychotic use were associated with higher initial lurasidone doses ( p < 0.05). Odds of a 20 mg/day increase in initial lurasidone dose was 1.6-times higher for patients with substance use [95% confidence interval (CI): 1.16−2.24], 2.6-times higher with hyperglycemia problems (95% CI: 1.15−5.83), 1.7-times higher with obesity (95% CI: 1.05−2.60), and 1.3 (95% CI: 1.01−1.78) and 1.8-times higher (95% CI: 1.17−2.86) with prior use of second- and first-generation antipsychotics, respectively. Conclusions: This real-world analysis of bipolar patients indicated that 40 mg or 80 mg/day were the most common starting doses of lurasidone. A majority of patients used concomitant psychiatric medications (polypharmacy). Higher doses of lurasidone were prescribed to patients with comorbidities or prior antipsychotic use. Adherence to lurasidone was comparable to or better than antipsychotic adherence reported in bipolar disorder literature.
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Yates, R., J. Sörensen, M. Bergström, G. Antoni, K. Nairn, J. Kemp, B. Långström, and A. Dane. "Distribution of Intranasal 11C-Zolmitriptan assessed by Positron Emission Tomography." Cephalalgia 25, no. 12 (December 2005): 1103–9. http://dx.doi.org/10.1111/j.1468-2982.2005.00966.x.
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Nine healthy volunteers aged 18-28 years were recruited into this open, single-centre, two-phase trial. In phase 1, two volunteers received a single dose of 11C-zolmitriptan 2.5 mg administered as a nasal spray and then underwent positron emission tomography (PET) scanning to determine the most appropriate times for scanning in phase 2. In phase 2, six volunteers received two doses and an additional volunteer one dose of 11C-zolmitriptan 2.5 mg intranasally. Volunteers underwent PET scanning over sectors covering one of the nasopharynx, lungs or abdomen, for up to 1.5 h postdose. The brain was also scanned and plasma zolmitriptan levels were measured. Almost 100% of the administered dose was detected in the nasopharynx immediately after dosing. This declined thereafter to about 50% at 20 min and to 35% at 80 min after dosing. Radioactivity appeared slowly in the upper abdomen, with 25% of given radioactivity detected at 20 min and persisting until 80 min after dosing. Minimal radioactivity was detected in the lungs. Radioactivity was detectable within brain tissue suggesting central penetration of zolmitriptan. Zolmitriptan in plasma had approached its maximum concentration by 15 min postdose. The data indicate initial absorption across the nasal mucosa contributing to an early systemic availability. 11C-Zolmitriptan administered intranasally was well tolerated.
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Konshina, Lidiya G. "Mortality from malignant neoplasms of the digestive system in the cities of the Chelyabinsk region affected by radiation accidents." Hygiene and sanitation 100, no. 6 (June 28, 2021): 568–79. http://dx.doi.org/10.47470/0016-9900-2021-100-6-568-579.
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Introduction. Due to the long-term radioactive contamination of a part of the territory of the Chelyabinsk region, much attention is paid to the analysis of the health status of the population. One of the adverse effects of radiation is the occurrence of neoplasms. The highest doses of radiation as a result of many emergencies were received by the digestive organs. Material and methods. The study of adult mortality in the cities Kasli and Kyshtym over 50 years from 1947 to 1996. The following age groups were studied: 20-29, 30-39, 40-49, 50-59, 60-69, 70 years, and older. Results. An increase in the mortality rate from malignant neoplasms of the esophagus, stomach, intestines, and other digestive organs in the adult population over 50 years was found. The growth of indices has been observed since 1952. The maximum mortality values from esophageal and gastric ulcers were recorded from 1962 to 1971, from intestinal ulcers from 1972 to 1981. Several waves of increasing mortality were recorded: in the early 50s, after 1957, after 1967, in the late 70’s - early 80‘s of the XX century. The increase in mortality from malignant neoplasms of the digestive organs of all localities in the studied cities among women and people of the elderly (60-69 yrs) and (70 yrs and older) age, as a rule, began five years earlier. Among the population under 50 years of age, differences in cancer mortality from control values were poorly expressed. Conclusion. Mortality rates from malignant neoplasms of the esophagus, stomach, intestines, and other unspecified digestive organs in the adult population, especially in the ages of 50-59, 60-69, and 70 and older, in the cities of Kasli and Kyshtym in some periods significantly exceed the control values.
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Nichols, Kristen, Eun Kyoung Chung, Chad A. Knoderer, Lauren E. Buenger, Daniel P. Healy, Jennifer Dees, Ashley S. Crumby, and Michael B. Kays. "Population Pharmacokinetics and Pharmacodynamics of Extended-Infusion Piperacillin and Tazobactam in Critically Ill Children." Antimicrobial Agents and Chemotherapy 60, no. 1 (November 9, 2015): 522–31. http://dx.doi.org/10.1128/aac.02089-15.
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ABSTRACTThe study objective was to evaluate the population pharmacokinetics and pharmacodynamics of extended-infusion piperacillin-tazobactam in children hospitalized in an intensive care unit. Seventy-two serum samples were collected at steady state from 12 patients who received piperacillin-tazobactam at 100/12.5 mg/kg of body weight every 8 h infused over 4 h. Population pharmacokinetic analyses were performed using NONMEM, and Monte Carlo simulations were performed to estimate the piperacillin pharmacokinetic profiles for dosing regimens of 80 to 100 mg/kg of the piperacillin component given every 6 to 8 h and infused over 0.5, 3, or 4 h. The probability of target attainment (PTA) for a cumulative percentage of the dosing interval that the drug concentration exceeds the MIC under steady-state pharmacokinetic conditions (TMIC) of ≥50% was calculated at MICs ranging from 0.25 to 64 mg/liter. The mean ± standard deviation (SD) age, weight, and estimated glomerular filtration rate were 5 ± 3 years, 17 ± 6.2 kg, and 118 ± 41 ml/min/1.73 m2, respectively. A one-compartment model with zero-order input and first-order elimination best fit the pharmacokinetic data for both drugs. Weight was significantly associated with piperacillin clearance, and weight and sex were significantly associated with tazobactam clearance. Pharmacokinetic parameters (mean ± SD) for piperacillin and tazobactam were as follows: clearance, 0.22 ± 0.07 and 0.19 ± 0.07 liter/h/kg, respectively; volume of distribution, 0.43 ± 0.16 and 0.37 ± 0.14 liter/kg, respectively. All extended-infusion regimens achieved PTAs of >90% at MICs of ≤16 mg/liter. Only the 3-h infusion regimens given every 6 h achieved PTAs of >90% at an MIC of 32 mg/liter. For susceptible bacterial pathogens, piperacillin-tazobactam doses of ≥80/10 mg/kg given every 8 h and infused over 4 h achieve adequate pharmacodynamic exposures in critically ill children.
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Rajičić, Vera, Vera Popović, Vesna Perišić, Milan Biberdžić, Zoran Jovović, Nebojša Gudžić, Vojislav Mihailović, Vladislava Čolić, Nenad Đurić, and Dragan Terzić. "Impact of Nitrogen and Phosphorus on Grain Yield in Winter Triticale Grown on Degraded Vertisol." Agronomy 10, no. 6 (May 26, 2020): 757. http://dx.doi.org/10.3390/agronomy10060757.
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The objectives of this study were to investigate: (1) the effects of fertilization, environment, and their interactions on the thousand grain weight (TGW), hectolitre weight (HW) and grain yield (GY) of winter triticale, and (2) the correlations between these traits in different environments. The invariable nitrogen (80 kg N ha−1), potassium (60 kg K2O ha−1) and two phosphorus (60 and 100 kg P2O5 ha−1) doses were used in Kragujevac location in central Serbia. Nitrogen was applied individually and in combination with two phosphorus rates and one rate of potassium fertilizer. Eight fertilization treatment controls and N80, P60, P100, N80P60K60, N80P100K60, N80P60 and N80P100 were examined during three growing seasons. The yield and quality of triticale significantly varied across years and treatments. The average yield of all treatments in the 2015 growing season was significantly greater than in the previous years (3.597 t ha−1). Combined usage of NPK fertilizer (80 kg N ha−1, 100 kg P2O5 ha−1 and 60 kg K2O ha−1) represented the excellent base for optimum supply of major nutrients, resulting in maximum GY (4.0 t ha−1). Negative and significant correlation was found between grain GY and TGW (−0.392*) in 2015, and positive highly significant correlation were in 2013 (0.648**) and 2014 (0.493**). The positive effect over complete application of fertilizer is the result of a lower pH value of the soil, as well as the low content of available phosphorus and potassium in Vertisol soil type. Optimizing fertilization for maximum profitability is of great importance in the future triticale production in Pannonian Environments.
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Kottakis, John, Giovanni Della Cioppa, Jacques Creemers, Louis Greefhorst, Violette Leclerc, Riccardo Pistelli, Tim Overend, et al. "Faster Onset of Bronchodilation with Formoterol than with Salmeterol in Patients with Stable, Moderate-Severe Copd: Results of a Randomized, Double-Blind Clinical Study." Canadian Respiratory Journal 9, no. 2 (2002): 107–15. http://dx.doi.org/10.1155/2002/604092.
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OBJECTIVES: To compare the onset and magnitude of bronchodilation after dry powder inhalations of formoterol fumarate (Foradil Aerolizer) versus salmeterol xinofoate (Serevent Diskus) with respect to normalized (*) forced expiratory volume in 1 s area under the curve 0 to 1 h after inhalation (FEV1AUC*0-1 h).DESIGN: A double-blind, double-dummy, multicentre, randomized, placebo controlled, single-dose, five-period crossover study.SETTING: Five centres in four countries -- one centre each in France, Greece and Italy, and two centres in the Netherlands.PATIENTS: Forty-seven patients aged 42 to 80 years (mean age 63.5 years) with chronic obstructive pulmonary disease (COPD) stage II and III, and mean baseline FEV11.17 L (range 0.56 to 1.77 L).INTERVENTIONS: Patients inhaled single doses of formoterol dry powder (12 and 24 μg), single doses of salmeterol (50 and 100 μg) and matching placebo on five separate days.MAIN RESULTS: The estimates of treatment difference in absolute terms (0.086 L) and percentage change from predose baseline (7.8%) for the primary end point, FEV1AUC*0-1 h, showed that formoterol 12 μg was statistically significantly superior to salmeterol 50 μg (P=0.0044 and P=0.0021, respectively). In addition, both doses of formoterol were statistically superior to placebo for both absolute improvement and percentage change (P=0.0001). The analysis of secondary variables also confirmed the superiority of formoterol over salmeterol.CONCLUSIONS: Formoterol is associated with a faster onset of bronchodilation than salmeterol in patients with COPD.
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Theodoro, Mariana, Andrew Demo, Cara Katzer, Clinton Katzer, Pam Shaw, and Catherine L. Satterwhite. "Human Papillomavirus Vaccine Frequency for University of Kansas Medical Center Pediatric Patients." Kansas Journal of Medicine 9, no. 1 (January 7, 2019): 1–5. http://dx.doi.org/10.17161/kjm.v9i1.8593.
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Background. Human papillomavirus (HPV) vaccination is recommendedfor all adolescents aged 11 to 12 years, but coveragein Kansas is exceptionally poor. To understand local coverage, receiptof the 3-dose HPV vaccine series among pediatric patients atthe University of Kansas Medical Center (KUMC) was evaluated.
Methods. All patients aged 11 to 12 years who were seen by aKUMC primary care provider (family medicine and pediatrics)in 2013 were included in the retrospective chart review. Recordswere reviewed through December 31, 2014 to capture the numberof HPV doses received, and receipt of other recommendedvaccines (tetanus-diphtheria-pertussis and meningococcal conjugate).Pearson’s chi-squared tests were used to evaluate relationshipsbetween HPV vaccination and patient characteristics.
Results. Of the 261 eligible females and 243 eligible males, 71.2%received ≥ 1 HPV vaccine dose, 55.2% received ≥ 2 doses, and39.3% completed the HPV vaccine series (3 doses). Although vaccineinitiation was slightly lower in males compared to females(67.1% vs. 75.1%, p = 0.047), no difference in vaccine completionwas seen between males and females (37.0% vs. 41.7%, p = 0.319).Over 80% of patients received other concurrently recommendedvaccines (Tdap: 81.7%, meningococcal: 81.3%). HPV series completionoccurred more often among Spanish-speaking femalescompared to English-speaking females (59.5% vs 37.7%; p < 0.01).Conclusions. The proportion of adolescents who received theHPV vaccination at KUMC is substantially higher than nationaland state estimates, but there is room for improvement forboth initiation and series completion. KS J Med 2016;9(1):1-5.
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Solassol, Jérôme, Carole Crozet, Véronique Perrier, Julien Leclaire, Florence Béranger, Anne-Marie Caminade, Bernard Meunier, Dominique Dormont, Jean-Pierre Majoral, and Sylvain Lehmann. "Cationic phosphorus-containing dendrimers reduce prion replication both in cell culture and in mice infected with scrapie." Journal of General Virology 85, no. 6 (June 1, 2004): 1791–99. http://dx.doi.org/10.1099/vir.0.19726-0.
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Over the last 30 years, many drugs have been tested both in cell culture and in vivo for their ability to prevent the generation of prions and the development of transmissible spongiform encephalopathies. Among the compounds tested, dendrimers are defined by their branched and repeating molecular structure. The anti-prion activity of new cationic phosphorus-containing dendrimers (P-dendrimers) with tertiary amine end-groups was tested. These molecules had a strong anti-prion activity, decreasing both PrPSc and infectivity in scrapie-infected cells at non-cytotoxic doses. They can bind PrP and decrease the amount of pre-existing PrPSc from several prion strains, including the BSE strain. More importantly, when tested in a murine scrapie model, the dendrimers were able to decrease PrPSc accumulation in the spleen by more than 80 %. These molecules have a high bio-availability and therefore exhibit relevant potential for prion therapeutics for at least post-exposure prophylaxis.
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Collins, Ruth, Derek Ewing, Bob Boggs, Noel Taggart, Aileen Drillingcourt, Martin Kelly, and Diana Patterson. "Opiate substitution prescribing in Belfast – two year follow up study." Irish Journal of Psychological Medicine 26, no. 4 (December 2009): 183–86. http://dx.doi.org/10.1017/s0790966700000665.
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AbstractObjectives:The objectives of the study were to identify the characteristics of the patients who were commenced in a newly developed opiate substitute prescribing (OSP) programme, to determine their rate of retention and to ascertain the patients' opinions of the service. We also wished to determine rates of blood borne viruses in this population.Methods:Data were collected from three sources: the Shaftesbury Square Hospital Substitute Prescribing Database, patient charts and an anonymous user views questionnaire. We also conducted viral screening. Inclusion criteria were opiate dependence according to ICD-101for at least one year, in individuals who were 18 years of age or older. The sample comprised the first 80 patients who attended the service, who were followed up over two years.Results:A total of 44% of our original cohort remained engaged with the service two years after commencement. Of the remainder, 18% engaged with OSP elsewhere and 13% completed a successful detoxification from all opiate drug use. Factors which were associated with continuation in the programme were prescription of methadone (as compared with buprenorphine), female sex and higher doses of OSP. Patients reported high levels of satisfaction with the service. Of those who were tested for blood borne viruses, more than half were positive for hepatitis C infection.Conclusions:The response to the development of the opiate substitution programme demonstrated that there was a need in the community which had not been met in the past. Service users who attended the programme reported high levels of satisfaction.
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Mikryukova, L. D., and S. A. Shalaginov. "Study of ophthalmic pathology in persons affected by radiation incidents." Reflection 10, no. 1 (December 25, 2020): 33–37. http://dx.doi.org/10.25276/2686-6986-2020-1-33-37.
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Aim. To investigate changes in the lens layers in individuals who have been chronically exposed to radiation over a long time. Methods. An analysis of the results of examination by an ophthalmologist in the clinical Department of the URCRM in 2018–2019 1 298 people. The examination was carried out according to a special in-depth program with photo fixation of changes in the lens. Results. An in-depth ophthalmological examination of patients affected by radiation accidents in the Ural region revealed an increase in cataract cases with increasing age, which corresponds to the trends in non-irradiated population. Initial changes in the lens were first detected in the age group from 40 to 50 years. At the age of less than 40 years, 41 people examined had no lens pathology. Changes in the cortical layers of the lens are the most common initial pathology in the development of cataract – in the age categories from 40 to 49 years and from 50 to 59, they accounted for 75 % of all types of lens opacities. Changes in the anterior lens capsule accounted for 21 % of all types of opacities, in the cortex –52 %, in the nucleus – 15 %, in the posterior capsule – 12 %. According to the intensity of lens opacities, the most frequent opacities of stages 1 and 2 were found in all layers. Changes in the lens nucleus gradually increase with age to 28–37 % in the age groups older than 70 years. The same trend is established in the increase in the intensity of yellow color in the staining of the lens. Opacity in the posterior lens nucleces capsule was found in 1 person aged 40–49 years, the greatest changes in the posterior lens capsule were observed in the oldest age group (over 80 years) – 20 % of all opacities at this age. Key words: ionizing radiation; small doses; cataract; involution processes.
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Thomson, A. B. R. "Omeprazole: Inhibiting the Final Common Pathway to Acid Secretion - The Acid Pump." Canadian Journal of Gastroenterology 3, no. 2 (1989): 61–71. http://dx.doi.org/10.1155/1989/463572.
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Omeprazole is the first agent in a new therapeutic advance class the proton or acid pump inhibitors which represents a significant therapeutic advance in the treatment of acid related diseases. Omeprazole reduces gastric acid secretion at its source – the acid pump of the parietal cell, thereby offering precise and consistent clinical effects. Omeprazole once daily has been shown to heal over 80% of duodenal ulcers within two weeks and over 95% within four weeks In gastric ulcer, the healing rates are up to 80% within four weeks and 96% within eight weeks. More patients are free from symptoms earlier on omeprazole therapy than with the H2receptor antagonists. Omeprazole is also effective in healing and symptom relief even where prolonged H2receptor antagonist therapy has been unsuccessful. Omeprnzole has been shown in clinical trials to be the first consistently effective treatment of erosive/ulcerative reflux esophagitis. Complete healing is achieved in the majority of patients and symptom relief is rapid. In clinical trials with 20 mg once daily, over 70% of patients healed within four weeks and up to 85% healed within eight weeks. Also. patients with erosive/ulcerative reflux esophagitis resistant to three months or more of treatment with full therapeutic doses of H2receptor antagonists have shown significant benefit, with healing rates of 49% within four weeks and 73% within eight weeks of therapy with omcprazole. The rare Zollinger-Ellison syndrome has been difficult to treat in the past due to the massive hypersecretion of gastric acid Omeprazole has proved highly effective in this syndrome, being well tolerated by patients who have received more than five years of continuous treatment with daily oral doses up to 160 mg. In summary, in extensive clinical trials omeprazole has been shown to be highly effective in the treatment of duodenal and gastric ulcers, erosive/ulcerative reflux esophagitis and Zollinger-Ellison syndrome. Omeprazole is well tolerated and is without any established side effects when used for short periods. It remains to be established whether H2blockers still represent the best available therapy for acute treatment of peptic disorders, and whether maintenance therapy is best achieved with H2blockers or with proton pump blockers.
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Whisner, Corrie M., Berdine R. Martin, Margriet H. C. Schoterman, Cindy H. Nakatsu, Linda D. McCabe, George P. McCabe, Meryl E. Wastney, Ellen G. H. M. van den Heuvel, and Connie M. Weaver. "Galacto-oligosaccharides increase calcium absorption and gut bifidobacteria in young girls: a double-blind cross-over trial." British Journal of Nutrition 110, no. 7 (March 14, 2013): 1292–303. http://dx.doi.org/10.1017/s000711451300055x.
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Adolescence is a time for rapid growth that represents an opportunity to influence peak bone mass. Prebiotic agents, such as galacto-oligosaccharides (GOS), increase Ca absorption in animal models and postmenopausal women. The objectives of the present study were to investigate the dose–response relationship of GOS supplementation on Ca absorption during growth and to assess changes in colonic microbiota to better understand the mechanism by which GOS is acting. A total of thirty-one healthy adolescent girls aged 10–13 years consumed smoothie drinks twice daily with 0, 2·5 or 5 g GOS for three 3-week periods in a random order. Fractional Ca absorption was determined from urinary Ca excretion over 48 h at the end of each 3-week period using a dual stable isotope method. Faecal microbiota and bifidobacteria were assessed by PCR–denaturing gradient gel electrophoresis and quantitative PCR. Fractional Ca absorption after the 48 h treatment with control, 5 and 10 g GOS/d was 0·393 (sd 0·092), 0·444 (sd 0·086) and 0·419 (sd 0·099), respectively. Significant improvements in Ca absorption were seen with both low and high doses of GOS compared with the control (P< 0·02), but it was not a dose–response relationship. The increase in absorption was greatest in the urine collected after 24 h, which is consistent with lower gut absorption. Faecal bifidobacteria increased (control 10·89 (sd 13·86), 5 g GOS 22·80 (sd 15·74) and 10 g GOS 11·54 (sd 14·20)) with the GOS treatment (P< 0·03). The results suggest that daily consumption of 5 g GOS increases Ca absorption, which may be mediated by the gut microbiota, specifically bifidobacteria.
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Bourne, Michael H., Jacques E. Chelly, C. V. Damaraju, Winnie W. Nelson, Jeff R. Schein, and David J. Hewitt. "Physical Therapists' Perceptions of Ease of Care in Patients Receiving 2 Forms of Analgesia After Total Hip Arthroplasty." Physical Therapy 90, no. 5 (May 1, 2010): 707–13. http://dx.doi.org/10.2522/ptj.20080323.
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Background Pain management modalities that facilitate patient mobility may contribute to recovery after total hip replacement (THR) surgery. Objective The aim of this study was to evaluate the impact of morphine intravenous (IV) patient-controlled analgesia (PCA) and the fentanyl iontophoretic transdermal system (fentanyl ITS) on physical therapists' ability to complete care tasks for patients after THR. Design The data were from an open-label, randomized, multicenter, active-control phase IIIb clinical trial. Methods The settings were 52 US-based teaching and community hospitals. The patients were ≥18 years of age (mean [SEM]: 62.8 [0.6] years in the fentanyl ITS group and 62.9 [0.6] years in the morphine IV PCA group); had an American Society of Anesthesiologists physical status of I, II, or III; and were scheduled to undergo primary unilateral THR surgery. The patients were randomized to receive analgesia for up to 72 hours via the fentanyl ITS (40 μg of fentanyl over 10 minutes for up to 6 doses per hour for 24 hours or 80 doses per system, whichever occurred first) or morphine IV PCA (1-mg bolus doses [with a 5-minute lockout interval between doses] for up to 10 doses per hour for 24 hours). All patients received the usual treatment administered by physical therapists. After each therapy session, physical therapists completed a validated Physical Therapist Ease-of-Care Questionnaire, which included time efficiency and convenience subscales (lower scores indicated more positive responses) and a satisfaction subscale (a higher score indicated a more positive response). Therapists whose average scores were ≤2 on all items of the time efficiency and convenience subscales or ≥4 on both items of the satisfaction subscale were considered responders. Results Higher percentages of physical therapists were responders for the fentanyl ITS than for morphine IV PCA on the subscales that assessed time efficiency (84.9% and 59.1%, respectively), convenience (86.6% and 71.2%, respectively), and satisfaction (54.3% and 30.5%, respectively). Higher percentages of physical therapists favored the fentanyl ITS than favored morphine IV PCA. Limitations The trial was limited by its open-label design, and physical therapists were more familiar with IV PCA than with the fentanyl ITS. Conclusions The findings demonstrate benefits to physical therapists of using the fentanyl ITS over morphine IV PCA in terms of time efficiency, convenience, and satisfaction.
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Maxam-Moore, VA, DJ Wilkie, and SL Woods. "Analgesics for cardiac surgery patients in critical care: describing current practice." American Journal of Critical Care 3, no. 1 (January 1, 1994): 31–39. http://dx.doi.org/10.4037/ajcc1994.3.1.31.
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BACKGROUND: In the last 10 years, the American Association of Critical-Care Nurses has twice ranked pain management as a priority issue for research and practice. Recent research findings suggest that undermedication of patients continues both in and out of critical care. Postoperative cardiac surgery patients have reported detailed recollections of pain experiences while in critical care, yet little is known about management of postoperative cardiac surgery pain. OBJECTIVE: The purpose of this study was to describe current practice related to analgesic prescription and administration for postoperative cardiac surgery patients in critical care. METHODS: Medical records of 80 adults undergoing cardiac surgery in two hospitals were randomly selected for review. Data pertaining to pain medications prescribed and doses administered for the day of surgery, first and second postoperative days were recorded for 66 eligible subjects. RESULTS: All but one patient had a prescription for intravenous morphine, hourly as needed. In addition, all patients had prescriptions for one or more oral analgesics as needed. Gender and age effects were noted for analgesic prescriptions. The average total amount of intravenous morphine given over the 3 days was 13.9 +/- 13.5 mg in an average of 4 +/- 3.7 doses. The average total number of acetaminophen with oxycodone tablets given over the 3 days was 5.8 +/- 5.4 tablets in an average of 3.6 +/- 3.0 doses. Age and hospital effects were noted in the administration of analgesics. CONCLUSIONS: The finding of small and infrequent analgesic doses is consistent with other studies conducted in and out of critical care. Important inconsistencies, or variations in practice, exist in both the prescription and administration of analgesics for postoperative cardiac surgery patients in the critical care setting.
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Bhatia, Smita, Doojduen Villaluna, Wendy Landier, Alexandra Schaible, Lindsey Hageman, Cara Hanby, Wendy Leisenring, et al. "Prevalence and Predictors of Non-Adherence to 6-Mercaptopurine (6MP) in Children with Acute Lymphoblastic Leukemia (ALL) - a Children’s Oncology Group Study." Blood 112, no. 11 (November 16, 2008): 897. http://dx.doi.org/10.1182/blood.v112.11.897.897.
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Abstract Use of contemporary risk-based therapy in children with ALL has resulted in five-year survival rates exceeding 80%. Achievement of durable remissions requires a maintenance phase composed of oral administration of antimetabolites (6-mercaptopurine and methotrexate) for approximately two years. Previous studies have shown that low systemic exposure to oral 6MP adversely affects prognosis, thus emphasizing the critical need for therapeutic levels throughout maintenance. However, significant inter-patient variability in red cell thioguanine nucleotide (6TGN – a major metabolite of 6MP) concentrations exists, and could in part be related to failure to adhere to prescribed therapy. Non-adherence in pediatric ALL patients has been reported – however, small sample sizes and varying methods of assessment make it difficult to understand the magnitude of this problem. The purpose of our study was to describe adherence to oral 6MP in a large multi-ethnic cohort of children with ALL. Patients were eligible to participate if they were diagnosed with ALL at age less than 22 years, belonged to one of four ethnic/racial groups (Asian, African-American, Caucasian, or Hispanic), and had completed at least 24 weeks of maintenance therapy. We have restricted the current report to Caucasians, where we have completed our target accrual. To measure 6MP adherence, we used the Medication Event Management System (MEMS) and supplied each patient with a MEMS TrackCap. This electronic cap allowed the collection of real-time data by recording the date and time(s) when the 6MP bottle was opened over a 6-month period. The MEMS data was downloaded at the end of the 6-month study period. Patients/parents also completed a self-administered sociodemographic questionnaire. Longitudinal analysis was performed using the Generalized Estimating Equations. A total of 173 Caucasian patients provided 26,424 person-days of observation for 6MP adherence. The median age at diagnosis was 5 years (1 to 19), and at study participation was 6 years (range, 2 to 20); median time from diagnosis was 18.8 months, and from start of maintenance, 8.1 months; 67% were males. NCI criteria for high-risk disease were present in 42% of the patients. The median annual household income was between $50K and $75K; 79% of the mothers and 72% of the fathers had received education beyond high school. The median number of household members (including patient) was 4 (range, 2 to 10). Adherence was defined as the ratio of 6MP bottle openings to actual 6MP doses prescribed, calculated as a percentage (“percent adherence”). Prescribed doses for the entire 6-month period were reviewed for each patient, and instances when 6MP was withheld by the prescriber due to toxicity or illness were taken into account for purposes of calculating adherence. The mean percent adherence over the 6-month study period was 85% (range 11% to 100%). The mean monthly percent adherence declined significantly over the 6-month study period (p=0.002). Multivariate analysis identified certain subgroups that were at increased risk of lower percent adherence (Figure): age >8 years at study entry (p=0.01); households that included members other than the mother, father, and patient (<0.001); father’s education ≤ high school or ≥ college degree (p=0.05), and annual household income <$20k or ≥ $100K (p=.045). In this study, 19% of the study participants were <80% adherent at the end of the first study month; this increased to 30% by the end of the 6-month study period. Over 6% of patients were <50% adherent at the end of the first month, and this increased to 11% at month 6 – demonstrating that over 10% of the patients were taking less than 50% of their prescribed doses of 6MP. This study demonstrates that non-adherence to 6MP is prevalent in children undergoing treatment for ALL and increases with time on maintenance. It further delineates certain sociodemographic variables that define those at highest risk for non-adherence. Patients from this study will be followed long-term to understand the impact of non-adherence on outcome. Future research needs to focus on developing targeted, multidisciplinary interventions to reduce non-adherence to therapy. Figure Figure
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Goldbloom, Ellen B., Arati Mokashi, Elizabeth A. Cummings, Sharon Abish, Susanne M. Benseler, Hien Q. Huynh, Wade Watson, and Alexandra Ahmet. "Symptomatic adrenal suppression among children in Canada." Archives of Disease in Childhood 102, no. 4 (November 9, 2016): 338.1–339. http://dx.doi.org/10.1136/archdischild-2016-311223.
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BackgroundAdrenal suppression (AS) is an under-recognised side effect of glucocorticoid (GC) use. AS may go undetected until a physiological stress precipitates an adrenal crisis. The incidence of AS has not been established. We sought to estimate the minimum national incidence and presenting features of paediatric symptomatic AS.MethodsThrough the established methodology of the Canadian Paediatric Surveillance Program, over 2500 paediatricians were surveyed monthly for 2 years (April 2010–March 2012) to report new cases of symptomatic AS.ResultsForty-six cases of symptomatic AS were confirmed. The estimated annual incidence is 0.35/100 000 children aged 0–18 years (95% CI 0.26 to 0.47). The most common presentations were growth failure (35%), non-specific symptoms (28%) or both (13%). Adrenal crisis occurred in six cases (13%). Thirty-seven children (80%) had received inhaled corticosteroid (ICS) alone or in combination with other GC forms. Many children received high but commonly prescribed doses of ICS.ConclusionsAS is responsible for significant morbidity in children, including susceptibility to adrenal crisis. The minimal estimated incidence reported is for the entire paediatric population and would be much higher in the at-risk group (ie, children treated with GCs). Close monitoring of growth and possible symptoms of AS, which may be non-specific, are important in children on all forms of GC therapy including ICS. To reduce the risk of AS, physicians must be aware of the risk of AS, revisit GC doses frequently and use the lowest effective dose.
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Bousamid, Anwar, Btissam Mzabri, Jamal Benyazid, Zerhoune Messaoudi, Abdelmajid Belabed, and Abdelbasset Berrichi. "THE EFFECT OF IRRIGATION DOSES ON THE PRODUCTIVITY OF Citrus clementina variety “Fina Berkane”, A VARIETY OF CLEMENTINE PRODUCED IN TRIFFA PLAIN, NORTH EASTERN MOROCCO." Journal of Experimental Biology and Agricultural Sciences 9, no. 4 (August 30, 2021): 432–38. http://dx.doi.org/10.18006/2021.9(4).432.438.
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Morocco is a Mediterranean country with an economy based on exporting agricultural products mainly to Europe. However, the ongoing climate change characterized by the frequency and the intensity of drought, along with the regularity of the rainfall is undeniably affecting the productivity of major agricultural products in Morocco. Citriculture is one of the key pillars of agricultural products in Moroccan conditions and the productivity of citriculture is tightly related to water management. To reduce this dependency under climatic change, a pilot study, over three years, has been launched to assess the effect of water stress on the production of clementine (Citrus clementina 'Berkane Clementine'). This study was carried out on the clementine, variety "Fina Berkane" at the Triffa plain, Northeastern Morocco. This variety was grafted on Volkameria rootstock with a density of 3m x 6m. Experimental variety was planted during October 2012, in loam-clay soil equipped with a drip irrigation system. Four doses of water irrigation (60%, 80%, 100%, and the conventional irrigation dose⩾120%) were tested based on the real water demand of the studied plant. Throughout the three-year monitoring, the effect of used water amount on the various parameters including yield, fruit size, and fruit quality have been studied. Results of the study revealed that the treatment 100% ETc provided a high number of fruits, yield, and a good quality ratio. It was also well reported that adopting a dose of 80% ETc could save a significant amount of irrigation water (more than 40% ETc) compared to the conventional irrigation dose (⩾120% ETc) without significantly affecting either the yield or the desired caliber profile (marketable standard).
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Kang, Daniel, Ulrich Simon, Felix M. Mottaghy, and Andreas T. J. Vogg. "Labelling via [Al18F]2+ Using Precomplexed Al-NODA Moieties." Pharmaceuticals 14, no. 8 (August 20, 2021): 818. http://dx.doi.org/10.3390/ph14080818.
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Over the past 20 years, 68Ga-labelled radiopharmaceuticals have become an important part in clinical routine. However, the worldwide supply with 68Ge/68Ga generators is limited as well as the number of patient doses per batch of 68Ga radiopharmaceutical. In the recent years, a new technique appeared, making use of the ease of aqueous labelling via chelators as with 68Ga but using 18F instead. This technique takes advantage of the strong coordinative bond between aluminium and fluoride, realized in the aqueous cation [Al18F]2+. Most applications to date make use of one-pot syntheses with free Al(III) ions in the system. In contrast, we investigated the labelling approach split into two steps: generating the Al-bearing precursor in pure form and using this Al compound as a precursor in the labelling step with aqueous [18F]fluoride. Hence, no free Al3+ ions are present in the labelling step. We investigated the impact of parameters: temperature, pH, addition of organic solvent, and reaction time using the model chelator NH2-MPAA-NODA. With optimized parameters we could stably achieve a 80% radiochemical yield exerting a 30-min reaction time at 100 °C. This technique has the potential to become an important approach in radiopharmaceutical syntheses.
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Inugala, Anusiri. "Conservative management of chylothorax in infants using octreotide." International Surgery Journal 7, no. 12 (November 27, 2020): 4066. http://dx.doi.org/10.18203/2349-2902.isj20205358.
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Background: Chylothorax is defined as abnormal accumulation of lymphatic fluid in the pleural space and is a rare condition in neonates and infants. Chylothorax causes respiratory and nutritional problems and has a significant mortality rate. Octreotide is a long-acting somatostatin analogue that can reduce lymphatic fluid production and has been used as a new strategy in the treatment of chylothorax.Methods: Infants with spontaneous chylothorax over a period of 3 years were included in this study. A prospective, observational study was done. All patients were nil per oral initially. Oral feeds were resumed once the ICD output declined. Octreotide was given subcutaneously for all patients at a dose of 40 microgram/kg/day in 3 divided doses. Octreotide was stopped once the ICD output was less than 70-80 ml/day. ICD was inserted in all patients and removed once drainage was below 50 ml/day.Results: Five patients were diagnosed with chylothorax over a period of 3 years out of which 3 were male and 2 were females. 1 patient had right sided and 4 patients had left sided chylothorax. The average age of presentation was 5.6 months. Octreotide was administered for an average of 14.4 days (8-22 days). The average duration of ICD was 18.2 days. All patients recovered well and were discharged.Conclusions: Spontaneous chylothorax is rare in infants. Conservative management is usually successful. Early institution of oral feeds with octreotide preserves the child’s nutrition and avoids invasive procedures, such as reinsertion of chest tubes or surgery.
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Chung, Vincent M., Shannon McDonough, Philip Agop Philip, Dana Backlund Cardin, Andrew M. Lowy, Jacqueline K. Benedetti, and Charles Davic Blanke. "SWOG S1115: Randomized phase II clinical trial of selumetinib (AZD6244; ARRY 142886) hydrogen sulfate (NSC-748727) and MK-2206 (NSC-749607) versus mFOLFOX in patients withmetastatic pancreatic cancer after prior chemotherapy." Journal of Clinical Oncology 31, no. 15_suppl (May 20, 2013): TPS4145. http://dx.doi.org/10.1200/jco.2013.31.15_suppl.tps4145.
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TPS4145 Background: Pancreatic cancer remains a deadly disease and despite advances in chemotherapy treatment, survival for most patients is still less than one year. Over 80% of pancreatic cancers are KRAS mutant which activates the PI3K/AKT pathway and signals downstream to mTOR leading to cell growth, proliferation and survival. Recent data has shown that blocking both the PI3K/AKT and MEK pathways simultaneously is effective in KRASmutant tumors. Our trial is a novel, molecular targeted treatment approach for patients with metastatic pancreatic cancer that has the potential to establish a new treatment paradigm. Methods: S1115 was activated in SWOG in August 2012 and is currently IRB approved at 130 institutions within SWOG and the Clinical Trials Support Unit (CTSU). Patients (performance status 0 or 1) with metastatic pancreatic cancer failing standard gemcitabine chemotherapy are randomized to MK-2206 135 mg orally weekly plus selumetinib 100 mg orally daily or mFOLFOX IV every 2 weeks. Eligibility criteria allow metastatic patients who have progressed within 6 months of receiving adjuvant gemcitabine. Patients receiving prior 5-fluorouracil (excluding radiation-sensitizing doses), capecitabine, oxaliplatin, MEK or PI3K/AKT inhibitors are not eligible. Stratification factors include duration of prior systemic therapy and presence of liver metastases. The primary endpoint of this study is overall survival (OS) in patients treated with the combination of MK-2206 and selumetinib compared with those treated with mFOLFOX. Based on previous studies, median OS in the control group is approximately 6 months. Assuming a one-sided type 1 error of 10%, 80% power, approximately 2 years of accrual and 1.5 years of follow-up, 120 eligible patients will be accrued to detect an improvement in median survival from 6 to 9 months (corresponding to a 1.5 hazard ratio). Prospective tumoral tissue collection will be undertaken. ClinicalTrials.gov Identifier: NCT01658943. Support: NCI grants CA32102 & CA38926 Clinical trial information: NCT01658943.
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Tchaou, M., G. N. Gnakadja, B. N’timon, L. Sonhaye, A. Amadou, M. Dansou, L. K. Agoda-Koussema, K. Adjenou, and K. N’dakena. "Revue Des Doses D’exposition Et De La Justification Des Radiographies Standard En Pratique Pédiatrique Au Togo." European Scientific Journal, ESJ 12, no. 24 (August 30, 2016): 223. http://dx.doi.org/10.19044/esj.2016.v12n24p223.
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Aims: To assess the justification of indications and exposure doses to children during radiographics. Methods: Prospective study of 102 X-ray exams of children collected over a period of 6 months in the Department of Radiology of Kara Teaching Hospital. Objectives: To assess the rationale guidance and exposure doses to children when standard radiographic examinations. Methodology: prospective observational study of 102 standard radiographs (Rx) collected in the radiology department of the University Hospital of Kara on a 6 month period. Results: Male children were predominant with a sex ratio boy / girl of 1.3. The predominant age group was the 5 to 10 years. Chest X-rays were the most practiced exam, with 43%. According to the Guide of well practices of French Society of Radiology (SFR) and the French Society of Biophysics and Nuclear Medicine (SFBMN), 80% of exams were justified. The comparison of our results to diagnostic reference levels (DRLs) shows that 43% and 39% of standard X-rays had dosimetric values exceeds the RDLs respectively the entrance Dose (De) and Dose Surface Product (DSP). Conclusion:Our study reveals that compliance guidance assessments to the proper use of medical imaging examinations guide was not always effective but satisfactory. The study dosimetric constants showed that the dose to children exceeded in a large proportion of the French and Belgian DRLs.
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Jain, Minish Mahendra, Chetan Dilip Deshmukh, Shailesh Arjun Bondarde, Niraj Bhatt, and Ganesh Divekar. "Phase I study of docetaxel injection concentrate for nano-dispersion (DICN), a novel polysorbate 80-free formulation of docetaxel." Journal of Clinical Oncology 30, no. 15_suppl (May 20, 2012): 2592. http://dx.doi.org/10.1200/jco.2012.30.15_suppl.2592.
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2592 Background: A polysorbate 80-free formulation of docetaxel may preclude the need for dexamethasone pre-medication and may also reduce toxic effects associated with polysorbate 80. DICN is a novel polysorbate 80-free formulation of docetaxel stabilized with lipid and polymer using NanotectonTM technology. We studied safety, tolerability, and the pharmacokinetics (PK) of DICN in patients with advanced solid malignancies. Methods: Entry criteria included: age 18-65 years, histologically/cytologically confirmed advanced malignancy, performance status ≤ ECOG 2, estimated survival ≥ 12 weeks, and adequate organ function. A standard phase I 3+3 dose escalation schema was employed with an increase of 12.5 to 50% over previous DICN dose level as per safety profile. The infusion was 60 min for 1 cycle and major objectives were to determine maximum tolerated dose (MTD), and PK and safety profiles. Premedication to prevent hypersensitivity was not administered to patients receiving DICN. Three patients were treated with docetaxel 75 mg/m2 to gather PK data. Plasma was analyzed for docetaxel level using a validated assay. Results: Twenty-seven patients treated with DICN had a mean age of 48.8 yrs (range 29-65); 21 were females; and entered with metastatic breast cancer (MBC; n=14), non-small cell lung carcinoma (NSCLC; n=6), ovarian (n=2), and other (n=5). Doses (mg/m2) studied were 60 (n=7), 75 (n=5), 100 (n=3), 125 (n=3), 150 (n=6), and 170 (n=3). Despite lack of dexamethasone premedication, no patient receiving DICN reported a hypersensitivity reaction. Two DLTs (febrile neutropenia) were reported at DICN 170 mg/m2. DICN PK (AUC0-24, AUC0-∞, and Cmax) increased in a dose proportionate manner from 60 to 170 mg/m2. Compared with docetaxel 75 mg/m2, Cmax and AUC0-24 of DICN 75 mg/m2 was 1.4 and 1.2 times higher, respectively, and 1.9 and 1.8 times higher, respectively for DICN 150 mg/m2. The median Tmax of DICN 75 mg/m2 and docetaxel 75 mg/m2 were 1.00 and 0.517 hours, respectively. Conclusions: In this study,DICN demonstrated acceptable tolerability and a favorable PK profile. A 150 mg/m2 is the recommended phase II dose for DICN.
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Ruedas, Angel, Ricardo Perez, Valentin Garcia, Alicia Smucler, Pilar Bravo, Joaquin Martinez, Pilar Sabin, Pablo Guisado, and Carlos Montalban. "Tailored Low Dose Lenalidomide with Low Dose Dexamethasone (len/dex) in Previously Treated Patients with Multiple Myeloma Older Than 70 Years Requiring Treatment." Blood 114, no. 22 (November 20, 2009): 4950. http://dx.doi.org/10.1182/blood.v114.22.4950.4950.
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Abstract Abstract 4950 Background & Aims The management of elderly patients with Multiple Myeloma (MM) previously treated requiring further therapy (although in most cases palliative) is very difficult due to the presence of concomitant diseases, decreased bone marrow reserve, systemic toxicity, relatively decreased renal function and general problems of old age. As in this setting the tolerability of standard doses of conventional chemotherapy, high doses of dexamethasone or IMiDs is a concern, we report the preliminary results of the combination of tailored low doses of lenalidomide (len) and low doses of dexamethasone (dex). Methods We retrospective analyze the results of the combination of low dose lenalidomide and low dose of dexamethasone (len/dex) in 14 patients aged over 70 years with pretreated MM and progressive disease. Low doses of len (5-10 mg daily for 21days) were initially given and flexibly modified in subsequent cycles according to response and toxicity, along with low doses of dex (20-40 mg/day for 4 days) in most (12) patients. G-CSF and red cell transfusions were used when needed. Patient risk was stratified following the Salmon and Durie (S&D) score and the International Staging System (ISS). Response was assessed with the IMWG criteria. Results Median age was 80 years (70-90). All patients had received between 2-5 different previous modality treatments (m=2), including bortezomib (7), thalidomide (4) or PBSCT (2). 11 pts had IgG, m=3397mg/dl (868-4990), 2 IgA m=1460 (1050-1870) and another one BJ. 9 pts had κ and 4 » light chains. Median Hemoglobin level was 10 gr/dl (7.2-11.4) and median creatinine level 1.19 mg/dl (0.75-1.63). 11 (78%) had bone disease. 9 pts had S&D stage II, 4 stage III and another one stage I. 7 pts had ISS stage II, 4 had stage I and 2 stage III. Patients received between 2 and 13 cycles of len/dex (m=6.8). 11 pts (78%) achieved Partial Remission (PR) and 2 (14%) achieved significant, but lesser that 50%, reduction of the M-component (Stable Disease: Std). Overall response (PR+Std) occurred in 13/14 patients (92.8%). The best response occurred between 2-12 cycles of len/dex. Grade III-IV bone marrow toxicity occurred in 5 pts (35 %) and neurological toxicity (PNP) in 5 pts (35%) (all of them had received previous bortezomib or thalidomide). Treatment was stopped in 6 pts: for unrelated causes (1), due to neurological (3) or haematological (1) toxicity and in 2 pts after achieving Std and both relapsed after 3 months. Conclusions Treatment with tailored low doses of lenalidomide and low doses of dexamethasone (len/dex) is an active and tolerable option for previously treated elderly patients with symptomatic MM. Low lenalidomide doses can be flexibly modified according to the quality of the response and the hematological toxicity that is expectable and manageable. Previous treatments with bortezomib or thalidomide is associated with neurotoxicity. Disclosures No relevant conflicts of interest to declare.
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Dal Cortivo, Cristian, Giuseppe Barion, Manuel Ferrari, Giovanna Visioli, Lucia Dramis, Anna Panozzo, and Teofilo Vamerali. "Effects of Field Inoculation with VAM and Bacteria Consortia on Root Growth and Nutrients Uptake in Common Wheat." Sustainability 10, no. 9 (September 14, 2018): 3286. http://dx.doi.org/10.3390/su10093286.
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This study investigated the effects of a commercial biofertilizer containing the mycorrhizal fungus Rhizophagus irregularis and the diazotrophic N-fixing bacterium Azotobacter vinelandii on root and shoot growth, yield, and nutrient uptake in common wheat (Triticum aestivum L.) in order to improve the sustainable cultivation of this widespread crop. The trials were carried out in controlled conditions (rhizoboxes) and in open fields over two years to investigate the interaction between inoculation and three doses of nitrogen fertilization (160, 120 and 80 kg ha−1) in a silty-loam soil of the Po Plain (NE Italy). In rhizoboxes, efficient root colonization by R. irregularis was observed at 50 days after sowing with seed inoculation, together with improved root tip density and branching (+~30% vs. controls), while the effects of post-emergence inoculation by soil and foliar spraying were not observable at plant sampling. In the open, field spraying at end tillering significantly increased the volumetric root length density (RLD, +22% vs. controls) and root area density (+18%) after about two months (flowering stage) in both years under medium and high N fertilization doses, but not at the lowest N dose. In absence of inoculation, RLD progressively decreased with increased N doses. Inoculation had a negligible effect on grain yield and N uptake, which followed a typical N dose-response model, while straw Zn, P, and K concentrations were seldom improved. It is concluded that medium-high N fertilization doses are required to achieve the target yield and standards of quality (protein contents) in wheat cultivation, while the use of this mixed VAM-PGPR biofertilizer appears to be a sustainable mean for minimizing the adverse effects of chemical N fertilizers on root expansion and for improving the uptake of low-mobility nutrients, which has potentially relevant environmental benefits.
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Troitskaya, Vera V., Elena N. Parovichnikova, Andrey N. Sokolov, Alina V. Kokhno, Zalina T. Fidarova, Olga A. Gavrilina, Tatiana I. Lobanova, et al. "The Choice of Treatment for Elderly AML-Patients: 7+3 or Low Doses ARA-C." Blood 134, Supplement_1 (November 13, 2019): 5136. http://dx.doi.org/10.1182/blood-2019-124056.
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Background Acute myeloid leukemia (AML) in older adults is a biologically and clinically distinct entity. These patients often have comorbidities, and their treatment must be chosen with caution. In AML patients over 60y old, cure rates are under 10% even after intensive chemotherapy (CT). Aim To compare the efficacy of different therapeutic approaches in elderly AML-pts treated in NRCH. Methods From 2002 till 2019, NRCH has conducted a prospective non-randomized study which included 80 AML-patients 60-81y (Me - 67y): 60-65 yy (n=53) and >65y (n=27); M/F - 35/45; de novo AML n=61 (76,25%), AML from MDS - n=13 (16,25%), «secondary» AML - n=6 (7,5%); cytogenetic risk: favorable n=1 (1,25%), intermediate n=49 (61,25%), poor n=30 (37,5%). The patients were stratified to different treatment approaches according to age. Patients 60-70y (n=40) mostly received 1-2 induction cycles 7+3 (ARA-C 100 mg/m2 bid; Dauno - 45-60 mg/m2 ), then 2 consolidation cycles 7+3 (Dauno - 45 mg/m2) and 2 years maintenance (5+5 with 6-MP). Patients >70y (n=22) were usually treated with 1-2 induction and 2 consolidation cycles of low dose Ara-C (LDAC) (10 mg/m2 sc bid, 28-days) and 3 years maintenance with 21-28-days LDAC. In some cases, fit patients over the age of 70y have got 7+3 (n=5) and some younger with comorbidities - LDAC (n=13). The analysis was done in May 2019. We evaluated treatment outcome according to age, cytogenetics and type of CT. Results The CR rate in the whole group of elderly AML-pts was 57,5% (46/80) with a median CR-duration - 10 mon (1-138 mon), early death - 16,25% (13/80) and resistance - 26,25% (21/80) with no major differences in the two age cohorts (<>70y). In order to assess of the efficacy of two chemotherapy options we have compared 7+3 and LDAC in patients aged 60-65 and older. In patients aged 60-65 CR-rate was higher -75% (21/28) after 7+3 vs 50% (2/4) after LDAC, with less resistant forms - 7% (2/28) vs 25% (1/4), respectively. In > 65y group CR-rate was identical in pts after 7+3 (47%, 8/17) and after LDAC (55%, 17/31) with similar numbers of resistant forms: 41% vs 29%. Early death rate did not differ among the groups. There was statistically higher CR-rate and lower resistant forms on 7+3 in pts aged 60-65 compared to older pts. - 75% vs 47% (p<0.05) and 7% vs 41% (<0.005) (Tab.1). Long-term results in the whole cohort of elderly patients were as follows: 1-y OS - 46%, DFS - 52,2%, 5-y ОS - 13%, DFS - 9% with high relapse rate (70%) development, mostly with early occurrence (Me - 12.8 mon). The median survival was statistically longer in patients aged 60-65y (n=32) comparing to older ones (n=48) - 15.4 vs 8 mon, respectively (p=0.0542), but DFS was equal (Fig.1). Higher incidence (87% vs 74%) and earlier relapse development (12 vs 16 mon) were registered in the group with poor cytogenetics comparing to favorable/intermediate (p=0,022). We didn't observe significant difference in long-term outcome of AML-pts older or younger 70y. Standard LDAC duration is 10-14 days, twice less than we used in our study. A landmark-analysis (from day 30 of induction) has shown that, if the 1st course-duration was less than 28 days, the median survival was shorter - 5,9 mo in comparison with 14,9 mo in pts with 28-days LDAC (p=0.12). The efficacy of 28-days LDAC was very similar to 7+3, mainly in patients aged 66 and older (Fig.2). Conclusion The outcome in elderly AML-patients is determined by age (more or less 65y) and the group of cytogenetic prognosis (poor vs favorable/intermediate). Intensive induction (7+3) is more preferable in patients aged 60-65 y as it produced the higher CR-rate and less resistant forms, results that are comparable to younger AML-patients. In patients older than 65y - CR-rate after 7+3 or 28-day LDAC was identical, and 28-days LDAC may become the choice of treatment for patients older than 65y. However long-term results are generally poor so new therapeutic strategies for elderly AML-patients are highly needed. Disclosures No relevant conflicts of interest to declare.
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Kozyreva, M. Yu, L. Zh Basieva, and A. Kh Kozyrev. "SYMBIOTIC ACTIVITY OF MEDICAGO VARIA MART. DEPENDING ON THE TYPE OF NITROGEN NUTRITION." TAURIDA HERALD OF THE AGRARIAN SCIENCES 4 (24) (November 2020): 72–80. http://dx.doi.org/10.33952/2542-0720-2020-4-24-72-80.
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The issue of the use of mineral forms of nitrogen for legumes is still a source of debate among scientists. Under the environmental conditions of the foothill zone of RNO-Alania, the field experiments were laid to study the activity of the symbiotic system and the productivity of the alfalfa depending on the type of nitrogen nutrition and the presence of a virulent active strain of rhizobia. The research was carried out in 2017– 2019. Soil – chernozems leached. Objects: crops of Medicago varia Mart.; industrial strain of rhizotorphin 425a; inoculum of high-mountain strains of nodule bacteria; starting doses of nitrogen fertilizers. The dimensions of the symbiotic apparatus were studied according to the G.S. Posypanov method. The specific activity of symbiosis was 4.2 to 9.0 mg/kg. The maximum amount of air nitrogen (456.1 kg/ha) for three years of experiments was fixed by the symbiotic system of alfalfa in the variant with pre-sowing seed inoculation with high-mountain strains of nodule bacteria. This indicates their higher activity and competitiveness compared to the industrial strain of rhizotorphin 425a and indigenous strains of rhizobia from the pre-mountain zone of RNO-Alania. Mineral forms of nitrogen significantly inhibited the activity of the symbiotic system. As a result, the amount of fixed nitrogen decreased by 3.5–9.0 %. In the pre-mountain zone, under natural conditions, the growth and development of plants were provided with atmospheric nitrogen by 66 %, the rest of the need for the element (34 %) they satisfied with soil nitrogen. The maximum involvement of molecular nitrogen of the atmosphere in the biological cycle was distinguished by the variant with pre-sowing inoculation of seeds by virulent active strains of rhizobia, in which the share of air nitrogen participation in plant nutrition averaged 71–73 % over the three years of research.
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Quintás-Cardama, Alfonso, Hagop Kantarjian, Farhad Ravandi, Guillermo Garcia-Manero, Stefan Faderl, Pierce Sherry, Mark Brandt, et al. "Outcomes of Patients with Newly-Diagnosed Acute Myeloid Leukemia Over the Last 5 Decades At M.D. Anderson Cancer Center." Blood 118, no. 21 (November 18, 2011): 2606. http://dx.doi.org/10.1182/blood.v118.21.2606.2606.
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Abstract Abstract 2606 Background: For the last 40 years, cytosine arabinoside (ara-C) combined with anthracycline (at different dose schedules) has been considered standard therapy for AML. Multiple novel agents have been added to that combination in an attempt to improve AML outcomes. We evaluated the survival of patients with AML treated at our institution over the last 5 decades. Methodology: A total of 3,631 patients with newly-diagnosed non-APL AML, 294 CBF-AML, and 237 APL registered in the MDACC Leukemia Database (1965–2010) were evaluated. Patients were divided by decade of referral. Outcomes in specific AML subtypes were evaluated in patients enrolled in 80 different chemotherapeutic protocols used since 1985 when cytogenetic information was consistently available. Analyses comparing different regimens included only protocols that accrued a minimum of 30 patients. Results: Median overall survival (OS) per decade (1960 to 2010) was 2.1, 8.5, 8.5, 10.4, and 12.5 mos. 1-yr OS was 26%, 41%, 41%, 45%, 51% (Fig 1A). While the prognosis remains poor, incremental improvements in median OS were observed both in patients <60yr (3.7, 11.8, 13.8, 15.7, 19.4 mos; p<0.001) and ≥60yr (0.7, 1.6, 3.7, 5.8, 7.6 mos; p<0.001). As expected, cytogenetics predicted response to chemotherapy, with complete response (CR) rates of 90%, 66%, 58%, 38% for patients with core-binding factor (CBF) AML, cytogenetically-normal (CN) AML, complex cytogenetics, or -5/-7 abnormalities, respectively. The achievement of CR during induction remained a critical prognostic factor across decades; regimens that produced CR rates ≥60% rendered improved OS rates over those inducing CR rates in <60% of patients (53 vs 28wks; p=0.0001). Patients treated with regimens containing ≥1g/m2 versus <1g/m2 of ara-C per course rendered higher CR (65% vs 58%; p=0.0001), CR duration (67 vs 48wks; p=0.002), and median OS (55 vs 48wks; p=0.06) rates, with similar low early mortality (first 8wks) rates among patients <60yr (12% vs 13%) but higher early mortality among patients ≥60yr (30% vs 21%). When comparing idarubicin (12mg/m2x3) vs daunorubicin (45mg to 60m/m2×3) combined with equal ara-C doses, idarubicin-containing regimens induced higher CR (66% vs 52%; p=0.005) and OS (61 vs 46; p=0.06). Based on these data, we developed the AI regimen (ara-C: 1.5g/m2×3d and idarubicin: 12mg/m2×3d) in 1990's for the treatment of newly diagnosed AML (n=486; CR, CR duration, and OS rates: 61%, 63wks, and 48wks). Four agents (sorafenib, SAHA, G-CSF and tipifarnib) improved CR, CR duration, and OS rates when added to the AI backbone (compared to AI alone) amongst patients with non-CBF, non-APL AML: 84%/58wks/NR, 74%/42wks/68wks, 76%/82wks/83wks, 61%/72wks/54wks, respectively. The addition of G-CSF to AI (AIG; n=137) appeared to improve CR, CR duration, and OS rates (77%/87wks/86wks) over the AI regimens, even after removing CBF-AMLs (n=22; 76%/82wks/83wks) but not when fludarabine was substituted for idarubicin (AFG; n=413; 57%/42wks/35wks). Fludarabine-based regimens designed in the 1990's such as FA (n=290; 72%/NR/85wks) but not FAI (n=265; 54%/42wks/32wks) improved upon AI. However, when CBF-AMLs were removed, the outcomes with FA (n=159; 55%/47wks/34wks) and FAI (n=260; 54%/41wks/32wks) were both inferior to AI-based combinations (n=860; 65%/64wks/55wks). In the 2000's, the FLAG-gemtuzumab regimen improved CR, CR duration, and OS (92%/NR/NR) compared with outcomes in the 80's (89%/21mo/28mo) and 90's (90%/22mo/35mo) (Fig 1B). Similarly, the use of ATRA+ATO+/−gemtuzumab improved outcomes in APL in the 2000's (88%/NR/NR) compared with the 80's (64%/18mo/18mo) and 90's (71%/NR/126mo) (Fig 1C). Conclusions: Albeit modestly, AML outcomes have improved every decade since 1960 due to improvements in supportive care, the use of higher doses of ara-C and idarubicin (over daunorubicin). The addition of certain targeted agents to chemotherapy backbones (e.g. sorafenib, SAHA, G-CSF, tipifarnib) may further improve outcomes in non-APL, non-CBF AML. CBF-AML outcomes have improved remarkably with FLAG-gentuzumab and APL outcomes have done so with ATRA+arsenic+/−gemtuzumab. Disclosures: No relevant conflicts of interest to declare.
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Kerezoudis, Panagiotis, Lorenzo Rinaldo, Mohammed Ali Alvi, Sandy Goncalves, Christine Hunt, Wenchun Qu, Timothy P. Maus, and Mohamad Bydon. "352 The Effect of Epidural Steroid Injections on Bone Mineral Density and Vertebral Fracture Risk: A Systematic Review and Critical Appraisal of Current Literature." Neurosurgery 64, CN_suppl_1 (August 24, 2017): 280. http://dx.doi.org/10.1093/neuros/nyx417.352.
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Abstract INTRODUCTION Epidural steroid injections (ESIs) are a common treatment for the management of patients with radicular back pain. It is also known that the long-term enteral administration of exogenous steroids disrupts bone health and skeletal micro-architecture METHODS A systematic and critical review of recent literature was conducted in accordance with PRISMA guidelines. RESULTS >A total of 8 studies were included in the analysis (6 retrospective, 2 prospective). A total of 7233 patients with a mean age ranging between 49 and 74 years and an average follow-up between 6 and 60 months were studied. Steroids that were used included triamcinolone, dexamethasone, and methylprednisolone (MP), with a mean number of injections ranging from 1 to 14.7 and average cumulative dose in MP equivalents between 80 and 8130 mg. A single ESI was shown to decrease BMD as measured at the femoral neck by 1.8%, and increase the risk of vertebral fracture by 21%. Significant reductions in BMD were associated with a cumulative MP dose of 200 mg over a one year period and 400 mg over three years, but not in doses of less than 200 mg of MP equivalents for postmenopausal women and at least 3 g for healthy men. The risk of osteopenia and osteoporosis was lower in patients that were receiving anti-osteoporotic medication during the treatment course. CONCLUSION ESIs can decrease BMD, both locally (lumbar spine) and systemically (femoral neck) and increase the risk of vertebral fracture. Therefore, ESIs should be recommended with caution, especially in patients at risk for osteoporotic fractures, such as women of postmenopausal age. Anti-osteoporotic medication might be considered prior to ESI.
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Griffiths, Malcolm. "Effect of Neutron Irradiation on the Mechanical Properties, Swelling and Creep of Austenitic Stainless Steels." Materials 14, no. 10 (May 17, 2021): 2622. http://dx.doi.org/10.3390/ma14102622.
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Austenitic stainless steels are used for core internal structures in sodium-cooled fast reactors (SFRs) and light-water reactors (LWRs) because of their high strength and retained toughness after irradiation (up to 80 dpa in LWRs), unlike ferritic steels that are embrittled at low doses (<1 dpa). For fast reactors, operating temperatures vary from 400 to 550 °C for the internal structures and up to 650 °C for the fuel cladding. The internal structures of the LWRs operate at temperatures between approximately 270 and 320 °C although some parts can be hotter (more than 400 °C) because of localised nuclear heating. The ongoing operability relies on being able to understand and predict how the mechanical properties and dimensional stability change over extended periods of operation. Test reactor irradiations and power reactor operating experience over more than 50 years has resulted in the accumulation of a large amount of data from which one can assess the effects of irradiation on the properties of austenitic stainless steels. The effect of irradiation on the intrinsic mechanical properties (strength, ductility, toughness, etc.) and dimensional stability derived from in- and out-reactor (post-irradiation) measurements and tests will be described and discussed. The main observations will be assessed using radiation damage and gas production models. Rate theory models will be used to show how the microstructural changes during irradiation affect mechanical properties and dimensional stability.
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Wilson, Wyndham H., Michael L. Grossbard, Stefania Pittaluga, Diane Cole, Deborah Pearson, Nicole Drbohlav, Seth M. Steinberg, et al. "Dose-adjusted EPOCH chemotherapy for untreated large B-cell lymphomas: a pharmacodynamic approach with high efficacy." Blood 99, no. 8 (April 15, 2002): 2685–93. http://dx.doi.org/10.1182/blood.v99.8.2685.
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Abstract We hypothesized that incremental improvements in the cyclophosphamide-doxorubicin-vincristine-prednisone (CHOP) chemotherapy regimen through optimization of drug selection, schedule, and pharmacokinetics would improve outcome in patients with large B-cell lymphomas. A prospective multi-institutional study of administration of etoposide, vincristine, and doxorubicin for 96 hours with bolus doses of cyclophosphamide and oral prednisone (EPOCH therapy) was done in 50 patients with previously untreated large B-cell lymphomas. The doses of etoposide, doxorubicin, and cyclophosphamide were adjusted 20% each cycle to achieve a nadir absolute neutrophil count below 0.5 × 109/L. The median age of the patients was 46 years (range, 20-88 years); 24% were older than 60 years; and 44% were at high-intermediate or high risk according to International Prognostic Index (IPI) criteria. There was a complete response in 92% of patients, and at the median follow-up time of 62 months, the progression-free survival (PFS) and overall survival (OS) rates were 70% and 73%, respectively. Neither IPI risk factors nor the index itself was associated with response, PFS, or OS. Doses were escalated in 58% of cycles, and toxicity levels were tolerable. Significant inverse correlations were observed between dose intensity and age for all adjusted agents, and drug clearance of doxorubicin and free etoposide was also inversely correlated with age (r = −0.54 andP2 = .08 and r = −0.45 andP2 = .034, respectively). Free-etoposide clearance increased significantly during successive cycles (P2 = .015). Lymphomas with proliferation of at least 80% had somewhat lower progression and those expressing bcl-2 had significantly higher progression (P2 = .04). Expression of bcl-2 may discriminate the recently described activated B-like from germinal-center B-like large-cell lymphomas and provide important pathobiologic and prognostic information. Dose-adjusted EPOCH may produce more cell kill than CHOP-based regimens. Dynamic dose adjustment may overcome inadequate drug concentrations, particularly in younger patients, and compensate for increased drug clearance over time.