Impact of adverse drug reaction of first line anti - tuberculous drugs on treatment outcome of tuberculosis under revised national tuberculosis control programme

Abstract

Background: Tuberculosis (TB), an infectious disease caused by Mycobacterium tuberculosis, is the major health care burden responsible for morbidity and mortality. The objective was to study the profile of adverse drug reactions (ADRs) and its outcome.Methods: It was a prospective observational study conducted in one of the RNTCP centre of Ahmedabad district. All TB patients visiting and taking short course of directly observed treatment (DOTS) were enrolled and monitored for ADRs. All the ADRs spontaneously reported or identified by the researcher were recorded and analyzed.Results: Total 974 patients screened during the study period 72 (7.79%) developed ADRs. Significantly higher occurrence of ADRs were in age group of 31- 40 years (p<0.01). Out of these 72 patients, 49 (68%) were having pulmonary TB. No statistically significant association was found between gender of patient, site of TB and occurrence of ADRs (p>0.05). Occurrence of ADRs was significantly more (p<0.05) in patients of category I TB (31, 43%). Out of the 49 (68%) pulmonary tuberculosis patients who developed ADR, 32 patients (44%) were sputum positive showing significant association (p<0.05). Gastro-intestinal side effects were most common ADRs followed by giddiness and headache. Nine patients required complete stoppage of offending agent, while 2 patients require treatment interruption and most of the patients (61) were managed with supportive medication without removing anti tubercular drug from their treatment regimen. Out of these 72 patients, majority (56) declared cured at the end of treatment.Conclusions: ADRs are major factor limiting completion of drug therapy under RNTCP and occurrence of drug resistance which requires attention of all health care professionals.