Résumé
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 at a tertiary care hospital. The patients with MDR tuberculosis on treatment with DOTS Plus regimen under RNTCP and who met the inclusion exclusion criteria were recruited after informed consent. ADRs were monitored daily till the patients remained admitted and thereafter monthly. Predisposing factors were recorded. Causality assessment was performed by Naranjo scale and WHO UMC scale, severity by Hartwig’s scale and avoidability by Halla’s scale.Results: There were 115 patients were recruited, 70 developed at least one ADR. 98 ADRs were reported. The commonest ADR reported were – gastrointestinal (38.76%), neurological (21.24%) and hepatobiliary (8.16%). Diabetes and HIV predisposed to development of ADRs. 58.18% ADRs were classified as possible and 37.5% as probable by Naranjo’s scale. 51.02% ADRs were classified as probable and 42.83% as possible by WHO-UMC. 56% were classified as mild, 36% moderate, and 6% severe via Hartwig’s scale. 51 ADRs were classified as avoidable and 40 ADRs were possibly avoidable.Conclusions: Monitoring and assessment of ADRs is necessary to promote awareness, curb resistance and maintain adherence.
Résumé
Background: The objective of this study was to evaluate incidence, patterns, and severity of angiotensin-converting enzyme inhibitor (ACEI) induced adverse drug reactions (ADR). Methods: A total of 500 hypertensive patients taking ACEI was enrolled in the study by taking an informed consent. Reporting of all ACEI-induced ADRs was done by filling CDSCO ADR form. All ADR reports were evaluated according to WHO-UMC causality assessment scale. Results: A total of 53 ADRs (31 males and 22 females) was observed in 500 hypertensive patients taking ACEI. Of 53 ADRs, 22 (41.51%) were mild, 28 (52.83%) were moderate, and only 3 (5.66%) were classified as severe. 7 ADRs (13.21%) were classified as certain, 30 ADRs (56.60%) were in probable category, 8 (15.09%) were in possible category, 4 (7.55%) in unlikely category, 3 (5.66%) in conditional category (unclassified), and 1 ADR was in unassessable (unclassifiable) category. Among 53 ADRs, 24 (4.80%) patients developed dry cough, 8 (1.60%) hypotension, 2 (0.40%) headache, 2 (0.40%) dizziness, 3 (0.60%) nausea/bowel upset, 3 (0.60%) rashes, 2 (0.40%) developed angioedema, 3 (0.60%) dysgeusia, hyperkalemia, acute renal failure, proteinuria are rare. Conclusions: Incidence of ADRs by ACEIs is 10.60% with cough as the most common ADR followed by hypotension. As enalapril is most frequently used ACEI, ADRs due to enalapril are more common.