Author(s): Dr. Santosh Kumar,
BACKGROUND The objective of this study was to study the adverse drug reaction profile of New Sputum-Smear Positive (NSP) patients of pulmonary tuberculosis (PTB) treated under DOTS in category-I, in continuation phase. A prospective observational study was carried out at General medicine OPD, Gulbarga Institute of Medical Sciences, Kalaburagi over a period of three months. MATERIALS AND METHODS The study included 180 newly diagnosed TB patients on anti?TB treatment under DOTS. A symptom-based approach was followed for monitoring ADRs. The severity was assessed by Modified Hartwig Scale and causality by WHO-UMC probability scale. Data was expressed as counts and percentages for discrete variables using Microsoft Excel. RESULTS Out of 180 patients, 104 patients experienced ADRs with an overall incidence of 57.7%. 56(31.1%) patients showed single ADR whereas 48(26.6%) patients had two or more ADRs. Gastritis alone was present in 45(73.7%) patients followed by itching 4(6.5%), arthralgia 5 (8.1%), jaundice in 3 (4.9%), and generalized weakness 2(3.3%) in patients. Vomiting was present in 34(70.8%) patients, neuropathy in 4 (8.3%) patients, arthralgia in 3 (6.25%) patients, jaundice, itching and generalized weakness in 2 (4.1%) patient each. 61 (58.6%) patients experienced mild, 36(34.6%) had moderate and only 7(6.7%) had severe ADRs. CONCLUSION The incidence of ADRs was 57.7% and GI irritation was found to be most common ADR reported by 73.7% patients.