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1

Sharma, Sushil, Ajay Kumar Gupta, and G. Jyothi Reddy. "Inter-rater and intra-rater agreement in causality assessment of adverse drug reactions: a comparative study of WHO-UMC versus Naranjo scale." International Journal of Research in Medical Sciences 5, no. 10 (2017): 4389. http://dx.doi.org/10.18203/2320-6012.ijrms20174564.

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Background: The causality assessment system proposed by the WHO collaborating centre for international drug monitoring, the Uppsala monitoring centre (WHO-UMC) and the Naranjo probability scale are the generally accepted and most widely used methods for causality assessment. Both these scales are structured, transparent, consistent, and easy to apply with distinct advantages. The PvPI recommends use of WHO-UMC scale while many clinicians prefer Naranjo scale for its simplicity. As both these scales are used very widely in practise, it is important to study the level of agreement among them, to
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Murali, Madhavi, Sarah L. Suppes, Keith Feldman, and Jennifer L. Goldman. "Utilization of the Naranjo scale to evaluate adverse drug reactions at a free-standing children’s hospital." PLOS ONE 16, no. 1 (2021): e0245368. http://dx.doi.org/10.1371/journal.pone.0245368.

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The relationship between the Naranjo scaling system and pediatric adverse drug reactions (ADR) is poorly understood. We performed a retrospective review of 1,676 pediatric ADRs documented at our hospital from 2014–2018. We evaluated patient demographics, implicated medication, ADR severity, calculated Naranjo score, associated symptoms, and location within the hospital in which the ADR was documented. ADR severity was poorly correlated with Naranjo interpretation. Out of the 10 Naranjo scale questions, 4 had a response of “unknown” greater than 85% of the time. Cardiovascular and oncological/i
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Rehan, H. S., Deepti Chopra, and Ashish Kumar Kakkar. "Causality assessment of spontaneously reported adverse drug events: Comparison of WHO-UMC criteria and Naranjo probability scale." International Journal of Risk & Safety in Medicine 19, no. 4 (2007): 223–27. https://doi.org/10.3233/jrs-2007-420.

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ADRs usually do not present with unique clinical and laboratory findings making it difficult to demarcate them from the concurrent illness. For the estimation of the probability that a drug caused an adverse event several methods have been developed namely, the WHO-UMC criteria, the Naranjo probability scale, the Kramer scale and the Karch and Lasagna scale. But none of the available assessment methods have been shown to produce a precise and reliable quantitative estimation of relationship likelihood. The present study was planned to compare the WHO-UMC causality assessment criteria and the N
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Ommurugan, Balaji, Sereen Rose Thomson, Amita Priya, and Navin Patil. "AUGMENTIN INDUCED THROMBOCYTOSIS: A MAIDEN CASE SERIES." Asian Journal of Pharmaceutical and Clinical Research 10, no. 5 (2017): 15. http://dx.doi.org/10.22159/ajpcr.2017.v10i5.17119.

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When an infected patient suffers from thrombocytosis, it is very difficult to identify beta-lactam antibiotic induced cases of the disease and separate those from the possibility that thrombocytosis is an acute-phase reaction in the infected patient. We present 3 cases who were treated with Augmentin for various indications and developed thrombocytosis during the treatment course. The Naranjo probability scale indicates Augmentin as the possible cause of the thrombocytosis in all our patients.KEYWORDS: Amoxicillin/clavulanic acid, Thrombocytosis, Adverse effects, Naranjo’s scale
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Misra, Saurav, Manmeet Kaur, Tirthankar Deb, et al. "Agreement and correlation between WHO-UMC Causality scale and the Naranjo algorithm for causality assessment of adverse drug reactions at tertiary care center in Northern India." Journal of Family Medicine and Primary Care 14, no. 4 (2025): 1252–58. https://doi.org/10.4103/jfmpc.jfmpc_1148_24.

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Abstract Background: To develop a structured and harmonized causality assessment method has been a holy grail in pharmacovigilance. The Pharmacovigilance Programme of India (PvPI) recommends the use of the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) scale, whereas many clinicians prefer the Naranjo algorithm for its simplicity. There is no universally accepted method for the causality grading of ADRs. In the present study, we assessed agreement and correlation between the two widely used causality assessment scales, that is, the WHO-UMC criteria and the Naranjo algorithm. Mat
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6

Friedman, Joseph H. "The Naranjo Scale and Tardive Syndromes, a Historical Perspective." Clinical Neuropharmacology 42, no. 5 (2019): 188. http://dx.doi.org/10.1097/wnf.0000000000000363.

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Okuyucu, Muhammed, Beytullah Yıldırım, Tahir Tahir, and Ahmet Bektaş. "DEVELOPMENT OF THE NEUTROPENIA ASSOCIATED WITH SOMATOSTATIN: A RARE CASE REPORT." Samsun Medical Journal 1, no. 1 (2023): 28–31. https://doi.org/10.5281/zenodo.10913253.

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Somatostatin is a form of polypeptide hormone, which is usually used in the treatment of gastroesophageal variceal bleeding, endocrine tumours and fistulas, and may lead side effects such as nausea, vomiting and abdominal pain. Drug-induced neutropenia is a rare case; however, it is a serious side effect which threatens life. In this report, we are presenting a 32-year-old male patient with cryptogenic liver cirrhosis who developed neutropenia and started somatostatin infusion twice due to the esophageal variceal bleeding. This case was evaluated as a definitive drug side effect according to N
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8

Ananda, Hesti Aulia, Darini Kurniawati, Risyda Komalia, and Melviani. "STUDI FARMAKOVIGILANS TERAPI TUBERKULOSIS PARU PASIEN RAWAT JALAN DI RSUD ULIN BANJARMASIN." JURNAL ILMIAH FARMASI AKADEMI FARMASI JEMBER 7, no. 2 (2024): 16–25. https://doi.org/10.53864/jifakfar.v7i2.197.

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Pulmonary tuberculosis (TB) is an infectious disease caused by the bacteria Mycobacterium tuberculosis. The prevalence of pulmonary TB sufferers in Indonesia is 8.4% and is number 3 in the world, however, because the treatment takes a long period of time, the TB program in Indonesia has not been completed and the target is to eliminate TB in Indonesia by 2030. Long treatment allows the occurrence of drug side effects. TB. Therefore, it is necessary to assess drug use in terms of side effects of pulmonary TB drugs using the Naranjo Algorithm. This study aims to determine the incidence of side e
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9

Bajracharya, Sangha Ratna, Rakesh Ghimire, Pradip Gyanwali, and Anjan Khadka. "Causality Assessment of Adverse Drug Reaction Using Naranjo Probability Scale: A Retrospective Study." Medical Journal of Shree Birendra Hospital 19, no. 1 (2020): 16–19. http://dx.doi.org/10.3126/mjsbh.v19i1.21573.

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 Introduction: Globally, Adverse Drug Reaction (ADR) has been listed as the sixth leading causes of death. Recognition of ADR and establishment of relationship of drug with the symptom is the first step to the management of the problem. In this study, Naranjo algorithm has been used which is one of the most accepted tools for the assessment of causality of ADR with the suspected drug.
 Methods: A retrospective descriptive study was done which included 35 reported cases of ADRs in Drug Information Unit (DIU) in tertiary care teaching institute of Nepal from Dec 2
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10

Ranjit, Debbarma, Kumar Mrigendra, and Kumar Jeetendra. "Adverse Drug Reaction Pattern to Commonly used Antibiotics in a Tertiary Care Hospital: A Prospective Observational Study." International Journal of Pharmaceutical and Clinical Research 16, no. 10 (2024): 675–79. https://doi.org/10.5281/zenodo.14038257.

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<strong>Background:</strong>&nbsp;Drugs play a significant role in prophylaxis, diagnosis, and treatment of each and every disease. They are beneficial to the patients at the same time; they also result in unwanted and harmful effects which are called adverse drug reactions (ADRs). The aim of this study was to evaluate and analyse adverse drug reactions to antibiotics in patients of a tertiary care hospital at Bhagalpur, Bihar.&nbsp;<strong>Methods</strong>: This prospective observational study was carried out in Department of Pharmacology, Jawaharlal Nehru Medical College and Hospital, Bhagal
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11

V.Vijaya, Prasad* P.Venkata Sravan Kumar Dr R. Siddarama. "DEATH DUE TO STEVENS JOHNSON SYNDROME; A RARE CASE REPORT." Indo American Journal of Pharmaceutical Sciences 04, no. 07 (2017): 2072–76. https://doi.org/10.5281/zenodo.835176.

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Stevens Johnson’s syndrome is a life threatening drug induced hypersensitivity reaction. The drugs that cause SJS commonly are antibacterials (sulfonamides), anticonvulsants (phenytoin, phenobarbital, and carbamazepine), non-steroidal anti-inflammatory drugs (oxicam derivatives) and oxide inhibitors (allopurinol).Clinical symptoms are urticarial skin eruptions, arthralgia or arthritis, lymphadenopathy and fever.Treatment of Stevens Johnsons Syndrome includes systemic steroids, cyclosporine, intravenous immunoglobulin’s and supportive therapy.A male patient of 58 years was admitted in cardiolog
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12

Subba, Dil Prasad. "Piperacillin - Tazobactam -induce Allergic Reactions: A Case Study of a 70-year-old Female Patient." International Journal of Clinical Case Reports and Reviews 27, no. 02 (2025): 01–03. https://doi.org/10.31579/2690-4861/864.

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ADRs are an important issue in clinical practice, more so in geriatric patients receiving broad-spectrum antibiotic therapy. This case report discusses a 70-year-old woman who had an allergic reaction with generalized itching after the administration of Injection Piptaz (Piperacillin + Tazobactam) for some abdominal symptoms that had persisted for some days. It was initially treated with analgesics, gastric protectants, antibiotics, and antiparasitic agents. Afterward, the situation called for an additional intervention. Using the Naranjo Scale, the reaction was found to have a score above nin
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13

Dil, Prasad Subba, and Ravi Sharma. "Adverse Drug Reactions and Drug Interaction: GI Bleeding and Insomnia in a Hypertensive CVA Patient." medtigo Journal of Medicine 2, no. 4 (2024): e14011566. https://doi.org/10.5281/zenodo.14011566.

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A 61-year-old male with a history of cerebrovascular accident (CVA) and stage 3 hypertension presented with drowsiness and abdominal pain. The initial treatment included ondansetron, telmisartan, pantoprazole, aspirin, amlodipine, and Hosit. Adjustments were made after the patient's condition worsened, including the addition of atorvastatin, clopidogrel, and promethazine. However, the patient developed gastrointestinal bleeding, prompting the discontinuation of clopidogrel and the administration of low molecular-weight heparin (LMWH). The patient's condition improved after these adjustments, a
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14

Ommurugan, Balaji, Amita Priya, Navin Patil, and Joseph Thomas. "BLEOMYCIN-INDUCED REVERSIBLE ACUTE INTERSTITIAL PNEUMONIA." Asian Journal of Pharmaceutical and Clinical Research 10, no. 5 (2017): 6. http://dx.doi.org/10.22159/ajpcr.2017.v10i5.17121.

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As of now, about 380 medications are implicated in causing respiratory reactions and most common among that is drug-induced interstitial disease.Oral, parental as well inhalational drugs are known to cause drug-induced interstitial lung disease. Bleomycin is a chemotherapeutic agent used inthe treatment of lymphomas, germ cell tumors of the testes. Most common pulmonary toxicity is diffuse alveolar damage with nonspecific interstitialpneumonitis being next. We report a case of bleomycin-induced reversible acute interstitial pneumonia in a Hodgkin’s lymphoma patient with adriamycin, bleomycin,
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15

Sutton, S. Scott, Mark Jumper, Sean Cook, Babatunde Edun, and Michael D. Wyatt. "Ertapenem-Induced Encephalopathy in a Patient With Normal Renal Function." Journal of Investigative Medicine High Impact Case Reports 5, no. 1 (2017): 232470961668937. http://dx.doi.org/10.1177/2324709616689376.

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Drug-induced neurotoxicity is a rare adverse reaction associated with ertapenem. Encephalopathy is a type of neurotoxicity that is defined as a diffuse disease of the brain that alters brain function or structure. We report a patient with normal renal function who developed ertapenem-induced encephalopathy manifesting as altered mental status, hallucinations, and dystonic symptoms. The patient’s symptoms improved dramatically following ertapenem discontinuation, consistent with case reports describing ertapenem neurotoxicity in renal dysfunction. Since clinical evidence strongly suggested erta
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16

Sharma, Jyoti Bhagatram, Manjunath Nookala Krishnamurthy, Ankita Awase, et al. "Validation of a novel causality assessment scale for adverse events in non-small cell lung carcinoma patients treated with platinum and pemetrexed doublet chemotherapy." Therapeutic Advances in Drug Safety 12 (January 2021): 204209862199128. http://dx.doi.org/10.1177/2042098621991280.

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Aim: Accurate causality assessment (CA) of adverse events (AEs) is important in clinical research and routine clinical practice. The Naranjo scale (NS) used for CA lacks specificity, leading to a high rate of false positive causal associations. NS is a simple scale for CA; however, its limitations have reduced its popularity in favour of other scales. We therefore attempted to improvise the algorithm by addressing specific lacunae in NS. Methods: We attempted to modify the existing NS by (a) changing the weightage given to certain responses, (b) achieving higher resolution to certain responses
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17

Seger, D., K. Barker, and C. McNaughton. "Misuse of the Naranjo Adverse Drug Reaction probability scale in toxicology." Clinical Toxicology 51, no. 6 (2013): 461–66. http://dx.doi.org/10.3109/15563650.2013.811588.

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Arrang, Sherly Tandi. "LAPORAN KASUS-METRONIDAZOLE TABLET MENYEBABKAN PERUBAHAN WARNA URINE." JFIOnline | Print ISSN 1412-1107 | e-ISSN 2355-696X 12, no. 2 (2020): 155–58. http://dx.doi.org/10.35617/jfionline.v12i2.15.

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Seorang pasien wanita usia 38 tahun mengalami keputihan dan diberikan terapi metronidazole. Pasien mengalami efek samping obat berupa warna urin menjadi gelap kemudian merah beberapa jam setelah penggunaan metronidazole oral 500 mg tablet. Hubungan antara tablet metronidazole dan perubahan warna urin dinilai menggunakan Skala Naranjo. Berdasarkan dari penilaian efek samping obat menggunakan instrumen Naranjo Scale, dari 10 pertanyaan didapatkan total skor tujuh (7), yang artinya metronidazole kemungkinan penyebab warna urin menjadi lebih gelap/merah. Perubahan warna urin menjadi gelap atau kem
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19

Singh, Divita, Omnia A. E. A. Mesalhy, and Michael J. Cawley. "Heparin-Induced Hyperkalemia Assessment Utilizing the Naranjo Adverse Drug Reaction Probability Scale: A 40-Year Systematic Review." Pharmacy 13, no. 2 (2025): 55. https://doi.org/10.3390/pharmacy13020055.

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Background: Adverse drug reactions have been reported as leading causes of morbidity and mortality. Unfractionated heparin- and low-molecular-weight heparin-induced hyperkalemia are side effects that have been reported in approximately 7 to 8% of heparin-treated patients. Algorithms, assessment tools, and decision aids are needed to assist in determining the causality of these adverse drug reactions. Aim: The aim of this study was to determine the number of case reports of hyperkalemia resulting from unfractionated heparin or low-molecular-weight heparin use by utilizing the Naranjo Adverse Dr
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Kamdi, Amit S., Pankaj N. Bohra, and Suvarna M. Kalambe. "Ofloxacin-induced maculopapular rash in the infant." International Journal of Basic & Clinical Pharmacology 7, no. 11 (2018): 2261. http://dx.doi.org/10.18203/2319-2003.ijbcp20184185.

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Adverse drug reactions (ADRs) are a major cause of morbidity and mortality in countries having limited healthcare resources. The ofloxacin is an antimicrobial used for treating several bacterial infections. The ofloxacin, belonging to quinolone group of drugs, is bactericidal and acts by inhibition of bacterial DNA gyrase. Among the adverse drug reaction of ofloxacin, skin rashes are rare. An ofloxacin-induced maculopapular rash is the unique rare condition in the infant. The present case report was assessing the causality in ofloxacin induced maculopapular rash in the infant. Naranjo Adverse
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Bhogaraju, Anand, Renuka Vakiti, Somabala Charishma Kandula, and Tabitha Jezreel. "Amisulpride-induced phonic and motor tics: A rare case report." Telangana Journal of Psychiatry 10, no. 1 (2024): 93–95. http://dx.doi.org/10.4103/tjp.tjp_25_24.

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This is a rare side effect of amisulpride-induced phonic and motor tics that completely resolved within 2 weeks of stopping the drug. Naranjo adverse drug effect probability scale is eight, suggests that it's a probable causation of the tics.
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Najari, Fares, Amirhossein Setayesh, Gopinath E., and Sahar Mirzaei. "Evaluation of the Adverse Effects of Monoclonal Antibodies in Breast Cancer Treatment in a Tertiary Care Hospital in Bengaluru, India, in 2020." Journal of Advances in Medical and Biomedical Research 31, no. 146 (2023): 255–60. https://doi.org/10.30699/jambs.31.146.255.

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<strong>Abstract</strong> <strong>Background and Objective:&nbsp;</strong>Breast cancer (BC) is the leading cause of cancer mortality among women in different countries around the world, including India. Monoclonal antibodies (MoAbs) have emerged as a promising targeted treatment for BC, improving the survival rate of these patients with minimum adverse effects. This study aimed to investigate the severity of the adverse effects of MoAbs in an Indian population. <strong>Materials and Methods:&nbsp;</strong>This&nbsp;longitudinal&nbsp;descriptive study was conducted on 120 BC patients over six
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23

V, Vaishnavi, Khadeeja Nzamudeen, and Bincy Babu. "Case Report on Rauwolfia Induced Parkinsonismma." Journal of Clinical Case Reports & Studies 3, no. 9 (2022): 01–02. http://dx.doi.org/10.31579/2690-8808/137.

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Rauwolfia serpentina is a safe and effective treatment for hypertension. The objective of this case report is to enhance awareness for medical practitioners concerning Rauwolfia induced Parkinsonism, because recognition and appropriate management can enable proper treatment and prevent serious adverse outcomes. We report a patient, who is a known case of Systemic hypertension10 years ago and was taking 5 drops of Rauwolfia syrup, this caused the patient to suffer with rigidity and after discontinuation of Rauwolfia syrup, and full recovery was observed. The appraisal of the ADR reported, in th
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Karina, Lidya, and Hanny Cahyadi. "MYOPATHY ADVERSE DRUG REACTION ASSOCIATED WITH LANSOPRAZOLE: A CASE REPORT." MPI (Media Pharmaceutica Indonesiana) 2, no. 1 (2018): 35–40. http://dx.doi.org/10.24123/mpi.v2i1.1301.

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Proton pump inhibitor has been reported to cause myopathic adverse drug reactions in severaloverseas countries. Unfortunately, this case has never been raised and has not received much attentionin Indonesia. A case about myopathy associated with lansoprazole in 48-years old man has been recently reportedin Indonesia. Assessment methods used were time series data collection followed by causality analysisusing Naranjo Scale. The results of analysis revealed a Naranjo Scale of 9, which was interpreted as definite.This report concluded that lansoprazole could triggered myopathy adverse drug reacti
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25

Kedia, Pulkit R., Netravathi Angadi, and Vikram P. Thondaebhavi. "Adverse drug reaction due to combination of gabapentin and nortriptyline along with its causality assessment." International Journal of Basic & Clinical Pharmacology 11, no. 5 (2022): 494. http://dx.doi.org/10.18203/2319-2003.ijbcp20222150.

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The combination of gabapentin and nortriptyline is used as the first line drug treatment for management of neuropathic pain; however adverse drug reactions (ADRs) are one of the main causes for discontinuation of the therapy. This is a case study of erythematous maculopapular rash induced by combination of gabapentin and nortriptyline along with its causality assessment. A 55-year-old female came with complaint of back pain for 1 month. She was diagnosed as a case of L1 acute osteoporotic disc compression fracture. The patient was then administered combination tablet of gabapentin and nortript
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26

M., Shanthi, and Madhavrao C. "Study of adverse drug reaction and causality assessment of antidiabetic drugs." International Journal of Basic & Clinical Pharmacology 8, no. 1 (2018): 56. http://dx.doi.org/10.18203/2319-2003.ijbcp20185158.

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Background: Study about adverse drug reaction of antidiabetic drugs helps in ensuring maximum benefits of drug therapy.Methods: An observational study was carried out in patients attending tertiary care hospital in Kanyakumari district from August 2013 to August 2014. Adverse drug reactions due to the use of antidiabetic drugs were collected and adverse effects experienced by the patient was assessed using WHO scale, Naranjo scale, Schumock and Thornton scale and Hartwig and Siegel scale.Results: In this prospective study a total of 76 adverse events (41 male and 35 female) were identified. Mo
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García-Cortés, Miren, M. Isabel Lucena, Raúl J. Andrade, Raquel Camargo, and Ramiro Alcántara. "Is the Naranjo Probability Scale Accurate Enough to Ascertain Causality in Drug-Induced Hepatotoxicity?" Annals of Pharmacotherapy 38, no. 9 (2004): 1540–41. http://dx.doi.org/10.1345/aph.1e007.

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Comfort, Shaun, Darren Dorrell, Shawman Meireis, and Jennifer Fine. "MOdified NARanjo Causality Scale for ICSRs (MONARCSi): A Decision Support Tool for Safety Scientists." Drug Safety 41, no. 11 (2018): 1073–85. http://dx.doi.org/10.1007/s40264-018-0690-y.

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Goldenberg, Michael, Morgan Amigo, Somashekar G. Krishna, Nima Milani-Nejad, John C. Trinidad, and Benjamin H. Kaffenberger. "Validation of Rash and Nonspecific Eruption Diagnoses Using ICD-9 and ICD-10 Codes." Academic Dermatology 1, no. 1 (2023): 1–2. http://dx.doi.org/10.18061/ad.v1i1.8860.

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Despite being common cutaneous findings in the hospital setting, cutaneous drug eruptions have not been thoroughly validated for administrative claims data. The purpose of this study was to validate primary discharge diagnoses for the ICD code rash or other nonspecific eruptions by finding the positive predictive value (PPV) and to determine how often it was used to indicate an eruption that was eventually determined to be a drug eruption. Two dermatologists independently examined each of 39 hospital patient encounters to assess the validity of the ICD code used by stating whether the code use
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30

Hardiana, Iyan, Ivans Panduwiguna, Aji Abdaul Mujaki, Jerry Jerry, and Taufani Taufani. "Evaluasi efek samping obat pada pasien rawat inap di Rumah Sakit “X” di Jakarta." Health Sciences and Pharmacy Journal 6, no. 1 (2022): 35–41. http://dx.doi.org/10.32504/hspj.v6i1.670.

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One of the problems related to the use of drugs is the presence of side effects of drugs. Side Effects Drugs are responses to a drug that is detrimental and undesirable and that occur at doses typically used in humans for the prevention, diagnosis, or therapy of diseases or the modification of physiological functions. Side effects in drug administration are unexpected effects that can arise in treatment. This study aims to determine the number of Side Effects of Drug incidences and what drugs cause Side Effects of the Drug on inpatients at "X" Hospital Jakarta. The research method was descript
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Kassere, Sugandha, Juhi Kalra, Anurag Rawat, and Saurabh Kohli. "Adverse drug reactions monitoring of anticoagulant drugs used in cardiac coronary care unit of a tertiary care hospital." International Journal of Basic & Clinical Pharmacology 8, no. 11 (2019): 2512. http://dx.doi.org/10.18203/2319-2003.ijbcp20194794.

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Background: Cardiovascular diseases are one of the leading causes of morbidity and mortality worldwide. Anticoagulants are the most commonly implicated drugs, used in cardiology unit and they are responsible for a majority of adverse drug reactions (ADRs). The objective of the present study was to evaluate the pattern of ADRs reported with anticoagulant drugs used in the cardiology unit of a tertiary care hospital.Methods: This observational prospective study was undertaken from September 2017 to August 2018. Causality assessment of ADRs was assessed using the WHO and Naranjo scale of probabil
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32

Purushothama, Reddy K* Dr. Rajesh Asija Dr. M. Purushothaman Dr. S. Arshiya Banu. "A STUDY ON EVALUATION OF DERMATOLOGICAL ADVERSE DRUG REACTIONS CAUSALITY, SEVERITY AND PREVENTABILITY." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES 05, no. 08 (2018): 7357–63. https://doi.org/10.5281/zenodo.1341954.

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<strong><em>Background: </em></strong><em>The burden of dermatological Adverse Drug Reactions (ADR&rsquo;s) is resulting in switching or discontinuation of the drug as well as medication non-adherence. Active research is essential for evaluating, managing, reporting ADR&rsquo;s and strengthening the activity of pharmacovigilance of the country. The purpose of the study was to evaluate causality, severity, and preventability of Dermatological ADR&rsquo;s. </em> <strong><em>Method: </em></strong><em>A prospective observational study was carried out over a period of 1 year at the Department of De
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Bangolo, Ayrton I., Mahabuba Akhter, Auda Auda, et al. "A Case Report of Acute Severe Necrotizing Pancreatitis following the Johnson & Johnson Vaccine against the Novel SARS-CoV-2." Case Reports in Infectious Diseases 2023 (March 22, 2023): 1–4. http://dx.doi.org/10.1155/2023/9965435.

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Acute pancreatitis is an inflammatory condition, which is a leading gastrointestinal cause of hospitalization in the United States. Several conditions are associated with acute pancreatitis. More recently, there have been a few cases reported of acute pancreatitis following the Pfizer-BioNTech COVID-19 mRNA vaccine. To our knowledge, no cases of acute pancreatitis have been yet reported following the Johnson &amp; Johnson’s Janssen COVID-19 vaccine (J&amp; J vaccine). Herein we report a 34-year-old male with no significant past medical history admitted with acute necrotizing pancreatitis, the
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Sidharta, Emilia, Ivon Sindu Wijaya, and Hanny Cahyadi. "Confusion, difficulty concentrating, and slow response induced by ropinirole therapy in an elderly patient with secondary Parkinsonism: a case report." Jurnal Ilmiah Farmasi 16, no. 2 (2020): 112–17. http://dx.doi.org/10.20885/jif.vol16.iss2.art3.

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Background: Ropinirole is a therapy that is widely used in patients with Parkinson's disease or Restless Leg Syndrome (RLS). Some research journals show that the long-term use of ropinirole can cause side effects. But unfortunately, there are no published studies from Indonesia that show the side effects of ropinirole.. Objective: To report a case of several side effects induced by ropinirole therapy Method : Assessment methods used were time series data collection followed by causality analysis using Naranjo Scale. Results: This case reports several side effects such as confusion, difficulty
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Banerjee, Abhiram, Rajib Purkait, Gurudev Choubey, and Varanasi Roja. "Keynote Prescription in Homoeopathy: A Prospective Series of Fifteen Consecutive Cases." Homœopathic Links 33, no. 02 (2020): 109–15. http://dx.doi.org/10.1055/s-0040-1710577.

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Abstract Background Homoeopathy is a system of therapeutics which has a holistic approach towards diseased individual. Prescription in homoeopathy is based on individualisation which can be achieved in various ways. Keynote method is one of such various ways of prescription which needs to be validated by documentation of adequate and valid evidences in its favour. Methods This article presents a series of 15 consecutive cases in which prescriptions were made on the basis of keynote. The outcome was assessed using Outcome Related to Impact on Daily Living (ORIDL) and Measure Yourself Medical Ou
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Singh, Rohit Kumar, Rashmi, Mehnaz Hoda, Munish Kumar, Keshav Kumar Sinha, and Rani Indira Sinha. "A case of drug induced dizziness in a patient on anti-Parkinson drugs." International Journal of Basic & Clinical Pharmacology 12, no. 2 (2023): 268–71. http://dx.doi.org/10.18203/2319-2003.ijbcp20230400.

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Parkinson’s disease (PD) is the second most common age-related neurodegenerative disease, exceeded only by Alzheimer’s disease. Clinically, PD is characterized by resting tremor, rigidity (stiffness), bradykinesia (slowing), and gait dysfunction with postural instability. These are known as the classical or “cardinal” features of the disease. Levodopa remains the most effective symptomatic treatment for PD and the gold standard against which new therapies are compared. Levodopa is routinely administered in combination with a peripheral decarboxylase inhibitor to prevent its peripheral metaboli
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Khan, Sohil A., Gabriel Rodrigues, and Padma G. M. Rao. "Nicotinic acid derivative (xanthinol nicotinate) induced bullous eruption." International Journal of Risk & Safety in Medicine 18, no. 3 (2006): 159–62. https://doi.org/10.3233/jrs-2006-378.

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Xantinol nicotinate, a nicotinic acid derivative is used in the management of peripheral and cerebral vascular disorders and in hyperlipidaemias for over 40 years. Nicotinic acid derivatives have been associated with dermatological adverse effects. Flushing is claimed to be less frequent than with nicotinic acid, but has nevertheless been repeatedly observed. We present here a case of bullous eruptions due to xanthinol nicotinate, a probable reaction according to the Naranjo Adverse Drug Reaction Probability Scale.
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Oumar, Aboubacar Alassane, Mamadou Dakouo, Anicet Tchibozo, et al. "Antiretroviral-induced adverse drug reactions in HIV-infected patients in Mali: a resource-limited setting experience." International Journal of Basic & Clinical Pharmacology 8, no. 5 (2019): 831. http://dx.doi.org/10.18203/2319-2003.ijbcp20191565.

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Background: There are few reports in the literature from sub-Saharan Africa (SSA) regarding antiretroviral-induced adverse drug reactions (ADRs). Antiretroviral therapy (ART) is now widely available in SSA, and ADRs during HIV infection are also frequent. In this study, we reported the frequency and risk factors of ART-induced ADRs in a Malian population.Methods: This prospective cohort study was performed in the HIV Care and Counseling Centre (CESAC) of Mali from 2011 to 2012. Adult patients infected with HIV and who had recently started ART were included and followed-up clinically Were inclu
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Kose, Samet, Ercan Akin, and Mesut Cetin. "Adverse drug reactions and causality: the Turkish version of Naranjo Adverse Drug Reactions Probability Scale." Psychiatry and Clinical Psychopharmacology 27, no. 2 (2017): 205–6. http://dx.doi.org/10.1080/24750573.2017.1332512.

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Lakhani, Preet, Divya Singh, Shireen Barua, et al. "An observational study to analyze predisposing factors, causality, severity and preventability of adverse drug reactions among multidrug resistant tuberculosis patients treated under RNTCP program in Northern India." International Journal of Research in Medical Sciences 7, no. 3 (2019): 687. http://dx.doi.org/10.18203/2320-6012.ijrms20190918.

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Background: There were 4.1% of all new cases and 19% of previously treated patients were diagnosed with either multidrug resistant or rifampicin resistant tuberculosis in 2016. In the state of Uttar Pradesh, there were 2.16 new cases and 44,531 previously treated cases. The objectives of the study were to assess the predisposing factors, causality assessment, severity grading and avoidability of the adverse drug reactions (ADRs) of the antitubercular drugs in MDR-TB patients in a tertiary care hospital of northern India.Methods: This prospective observational study was conducted for 12 months
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Cui, Yuqi, Sayed Aliul Hasan Abdi, Jeanne Wei, and Gohar Azhar. "The Long-Term Cardiovascular Risks of Duloxetine Use in Older Adults: A Retrospective Medical Record-Based Adverse Drug Reaction Assessment." Journal of Clinical Medicine 13, no. 24 (2024): 7595. https://doi.org/10.3390/jcm13247595.

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Background: Duloxetine, a Serotonin–Norepinephrine Reuptake Inhibitor (SNRI), is frequently used to treat diabetic peripheral neuropathy, depression, and fibromyalgia. However, its long-term cardiovascular implications in older individuals remain underexplored, particularly in those with pre-existing cardiovascular diseases. This medical record assessment aimed to evaluate the potential cardiovascular risks of duloxetine use in older persons after prolonged use. Methods: We evaluated adverse drug reactions (ADRs) using six medical records from elderly individuals (aged 70–79) with cardiovascul
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Jeenalben, M. Patel, S. Patel Dishaben, R. Acharya Chetankumar, and R. Darji Bhargav. "Study of Adverse Drug Reactions in Inpatients of Medicine Department in a Tertiary Care Hospital: A Cross - Sectional Study." International Journal of Pharmaceutical and Clinical Research 14, no. 5 (2022): 641–55. https://doi.org/10.5281/zenodo.13829262.

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<strong>Introduction:</strong>&nbsp;Adverse Drug Reactions (ADRs) cause considerable morbidity and mortality worldwide. Early detection, evaluation and monitoring of ADRs are essential to reduce harm to patients and thus improve public health. Spontaneous reporting system (SRS) by health care professionals is common method for reporting suspected ADRs. Chances of ADRs in medicine department are high due to various factors. ADR monitoring and evaluation are the key components of effective drug regulation systems, clinical practice and public health programmes.&nbsp;<strong>Aim:</strong>&nbsp;To
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GARCÍA-CORTÉS, M., M. I. LUCENA, K. PACHKORIA, Y. BORRAZ, R. HIDALGO, and R. J. ANDRADE. "Evaluation of Naranjo Adverse Drug Reactions Probability Scale in causality assessment of drug-induced liver injury." Alimentary Pharmacology & Therapeutics 27, no. 9 (2008): 780–89. http://dx.doi.org/10.1111/j.1365-2036.2008.03655.x.

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Gonibala, Alfiana. "Adverse Drug Reactions Pada Pasien Pediatri Kanker Leukemia Limfoblastik Akut." Jurnal Farmasi Tinctura 3, no. 2 (2022): 56–64. http://dx.doi.org/10.35316/tinctura.v3i2.1930.

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Leukemia limfoblastik akut yang terjadi pada anak-anak sekitar 75-80%. Pengobatan utama leukemia limfoblastik akut pada anak-anak melibatkan penggunaan kemoterapi dengan regimen yang lebih kompleks dan dosis yang lebih tinggi. Regimen kemoterapi merupakan salah satu faktor penting yang menyebabkan terjadinya adverse drug reactions. Hal ini disebabkan karena obat kemoterapi dapat merusak sel-sel normal sehingga menyebabkan terjadinya efek. Tujuan dari penelitian ini adalah untuk mengidentifikasi persentase kejadian ADRs serta menilai kausalitas ADRs yang ditimbulkan oleh regimen kemoterapi dan
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Salahshour, Babak, Sajjad Sadeghi, Ahmad Sajadianfar, and Kambiz Soltaninejad. "Sudden Infant Death Due to Postvaccinal Myocarditis: A Case Report." International Journal of Medical Toxicology and Forensic Medicine 11, no. 3 (2021): 32227. http://dx.doi.org/10.32598/ijmtfm.v11i3.32227.

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Background: Vaccination is a fundamental strategy in public health for controlling and eradicating infectious diseases. However, the undesirable Adverse Events Following Immunization (AEFI) should be effectively monitored, prevented, and managed in societies. Previously, Sudden Infant Death (SID) has been reported as a serious AEFI. We present a rare case of SID in an 18-month-old girl due to severe myocarditis following vaccination. Case Presentation: An 18-month-old girl presented to the Emergency Department (ED) with a history of the injection of Diphtheria-Tetanus-Whole Cell Pertussis (DTw
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Arredondo-Garza, Teresa, Abraham Majluf-Cruz, Fedra Irazoque-Palazuelos, et al. "Peri-Infusional Adverse Reactions to Rituximab in Mexican Patients with Rheumatoid Arthritis." Latin american journal of clinical sciences and medical technology 1, no. 1 (2019): 28–34. http://dx.doi.org/10.34141/ljcs1446110.

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Background. The treatment of rheumatoid arthritis (RA) has significantly improved since the introduction of biologics like rituximab. Rituximab achieves selective B lymphocyte depletion and, thereby, reduce inflammation. It has adverse reactions related to the immunogenic response. Objective. The aim of this study was to evaluate the frequency and severity of rituximab adverse reactions in Mexican patients with RA. Methods. A prospective, observational, descriptive, open-labeled, multicenter cohort study of intensive pharmacovigilance was conducted during 17 months in 10 hospitals. We included
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Bernstein, Allan L., and Ann Werlin. "Pseudodementia Associated with Use of Ibuprofen." Annals of Pharmacotherapy 37, no. 1 (2003): 80–82. http://dx.doi.org/10.1345/aph.1c218.

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OBJECTIVE To report a case of dementing syndrome resulting from ibuprofen use. CASE SUMMARY A 76-year-old white man with normal mental status became confused, was lost in familiar places, and showed short-term memory loss after beginning a therapeutic regimen of ibuprofen 600 mg 3 times daily for osteoarthritis in anticipation of embarking on a foreign trip. Symptoms of dementia began within 1 week after taking ibuprofen and resolved completely within 1 week after the ibuprofen regimen was stopped. This pattern was repeated 6 months later, when the patient again traveled abroad. Consistently b
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Siti, Nor Fadhlina Misron, Misron Khairunnisak, and Zahiruddin Othman. "Unilateral Parotitis Secondary to Flupenthixol Decanoate in a Schizophrenia Patient: A Very Rare Side Effect." International Medical Journal 26, no. 5 (2019): 361–62. https://doi.org/10.5281/zenodo.3403422.

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Objective: Thioxanthene class, particularly flupenthixol is not yet an established cause of parotitis, a rare side effect of antipsychotics. However, the risk of parotitis is still possible due to its anticholinergic property. Results: We reported a case of flupenthixol decanoate-induced parotitis with xerostomia. According to the parotitis-specific criteria Modified Naranjo Probability Scale, flupenthixol decanoate is a probable cause of parotitis in this patient. Conclusion: Correct identification of flupenthixol as the responsible agent for anticholinergic-induced parotitis is the most pivo
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Kusumawardani, Larasati Arrum, Nisa Maria, and Yoga Amarta. "Adverse drug reactions evaluation of antimicrobials in COVID-19 inpatients using Modified Trigger Tool and Naranjo Algorithm." Pharmacy Education 23, no. 2 (2023): 1–8. http://dx.doi.org/10.46542/pe.2023.232.18.

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Background: The use of antimicrobials in COVID-19 treatment might increase the risk of adverse drug reactions (ADR). Therefore, the adverse effect further identification was needed to understand the safety profile of using these medicines. Objective: The research aims to evaluate the adverse effects of the use of COVID-19 antimicrobial agents, causality analysis, and factors related to this ADR. Method: Cross-sectional study using random sampling was conducted to obtain the data. The study used samples from COVID-19 adult inpatients in a hospital located in Java from July-December 2020. Advers
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Jha, Amit. "A naturalistic study on side effects of selective serotonin reuptake inhibitors in psychiatric out-patient department." Journal of Psychiatrists' Association of Nepal 11, no. 2 (2022): 22–28. http://dx.doi.org/10.3126/jpan.v11i2.57634.

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Introduction: &gt;Antidepressants are one of the most commonly prescribed psychotropic drugs. Six SSRIs are approved for various disorders. SSRIs have fewer side effects owing to its selective blocking the serotonin transporter. Nonetheless SSRI has several troublesome side effects, including nausea, diarrhoea, headache, dizziness, sexual side effects, tachycardia, or weight gain. Methodology: This cross-sectional comprised of 200 patients who were divided into two groups. Group 1 had participants who had received SSRI for less than 6 weeks duration and group 2 had patients who had taken SSRI
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