ABSTRACT
Objective: Many Fix Dose Combinations (FDCs) being introduced in India are usually irrational. The most pressing concern with irrational FDCs is that they expose patients to unnecessary risk of adverse drug reactions, for instance, pediatric formulations of nimesulide+paracetamol. Despite their wide clinical use, their gastro-intestinal toxicity is a major limitation. The aim of the present work was to evaluate the efficacy and safety of FDCs in non-steroidal anti-inflammatory drugs in the orthopedic department at a tertiary care teaching hospital. To study the effectiveness and safety parameters of fixed-dose combinations of Non-Steroidal Anti-inflammatory Drugs. Methods: This prospective, observational study was conducted among 150 out-patients of the orthopedic ward over a period of July 2013 to December 2013(Each combination with 50 patients). Three fixed-dose combinations utilized were paracetamol+diclofenac, paracetamol+ibuprofen and paracetamol+nimesulide. The effectiveness was analyzed by using Visual Analogue Scale (VAS) and Disease Activity Scale (DAS) and the safety criteria were analyzed by using the WHO probability scale and Naranjo scale. 150 orthopedic patients attending Out Patient Department were included. 50 participants for each of the combinations of fixed-dose combination (FDCs) of NSAIDs. Results: Out of 150 patients 33 patients developed adverse effects, and 17(51.51%) adverse effects due to the combination of Paracetmol+Nimuselide, 11(33.34%) adverse effects due to the Paracetamol+Ibuprofen and 5 (15.15%) were due to the combination of Paracetamol+Diclofenac. The maximum effectiveness (3.55±0.208) showed in the combination of paracetamol+diclofenac compared to the other two combinations. Conclusion: It was concluded from this study that the effectiveness and safety profile of PCM+DICLO is better than the other two FDCs.
ABSTRACT
The objectives of the study is to monitor and causality assessment of suspected ADRs by WHO Probability Scale in patients of tuberculosis undergoing treatment with anti-tuberculous drugs. An Open, Non- Comparative Study was carried out in the Medicine Department of Majeedia Hospital, Jamia Hamdard, over a period of 6 months. A total of 139 patients, satisfying Inclusion and Exclusion Criteria of the Study were enrolled. Potential study subjects were thoroughly interrogated for history in local dialect along with thorough clinical examination for both Pulmonary and Extra-pulmonary tuberculosis. The patients were followed upon a weekly basis during the period of treatment. Assessment of ADRs was done by formal methods; Timing, Pattern Recognition, Background Frequency and Re-challenge and the same was recorded in ADR Reporting and Documentation Form. All the categorical data was analysed by chi-square test on 120 patients. Causality assessment of ADRs was found to be statistically significant by WHO probability scale. 46.7% of patients reported ADRs to anti-tuberculous drugs. The severity of ADR’s was graded on 3- point scale (Mild-34.2%, Moderate-9.2%, Severe-3.3%). Close clinical monitoring in all tuberculosis patients for ADRs is important. ADRs remain one of the key factors for non-compliance of treatment, a reason for multi-drug resistance tuberculosis.