An Observational Prospective Study of Adverse Drug Reactions in New Smear Positive Patients of Pulmonary Tuberculosis Treated Under Directly Observed Treatment in Continuation Phase in General Medicine Opd at Gulbarga Institute of Medical Sciences, Kalaburagi
Year: 2018
Type: article
Study design: Observational Study
Abstract: BACKGROUND \nThe objective of this study was to study the adverse drug reaction profile of New Sputum-Smear Positive (NSP) patients of \npulmonary tuberculosis (PTB) treated under DOTS in category-I, in continuation phase. A prospective observational study was \ncarried out at General medicine OPD, Gulbarga Institute of Medical Sciences, Kalaburagi over a period of three months. \nMATERIALS AND METHODS \nThe study included 180 newly diagnosed TB patients on anti‑TB treatment under DOTS. A symptom-based approach was \nfollowed for monitoring ADRs. The severity was assessed by Modified Hartwig Scale and causality by WHO-UMC probability \nscale. Data was expressed as counts and percentages for discrete variables using Microsoft Excel. \nRESULTS \nOut of 180 patients, 104 patients experienced ADRs with an overall incidence of 57.7%. 56(31.1%) patients showed single ADR \nwhereas 48(26.6%) patients had two or more ADRs. Gastritis alone was present in 45(73.7%) patients followed by itching \n4(6.5%), arthralgia 5 (8.1%), jaundice in 3 (4.9%), and generalized weakness 2(3.3%) in patients. Vomiting was present in \n34(70.8%) patients, neuropathy in 4 (8.3%) patients, arthralgia in 3 (6.25%) patients, jaundice, itching and generalized \nweakness in 2 (4.1%) patient each. 61 (58.6%) patients experienced mild, 36(34.6%) had moderate and only 7(6.7%) had \nsevere ADRs. \nCONCLUSION \nThe incidence of ADRs was 57.7% and GI irritation was found to be most common ADR reported by 73.7% patients. \n
Authors: Dayanand Raddi, Santosh Kumar, Bande Rao Patil
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W2890740652