A study on treatment outcome and adverse drug reactions among extra pulmonary tuberculosis patients treated under DOTS in a tertiary care hospital
Keywords:ATT - antitubercular drugs, ADR - Adverse drug reactuins, DOTS -Directly Observed Treatment Short-course, Extra-pulmonary Tuberculosis, Hartwig’s scale, Naronjo’s causality assessment scale, World Health Organization -Uppsala monitoring centre (WHO-UMC)
Background: Pulmonary tuberculosis being the predominant manifestation of the disease Extra-Pulmonary sites can also involve as a result of dissemination from a chief focus. The present study aims to determine the presentation and outcome of patients with extra-pulmonary tuberculosis treated with category I DOTS and to identify the incidence and pattern of ADRs caused by anti-tubercular drugs and to assess the causality and severity of the reported ADRs.
Methods: Data was collected from cases of Tuberculosis patients diagnosed and treated under category I DOTS at Sri Siddhartha Medical College for the period of one year (during 2015). These patients were monitored for ADRs during OPDs and hospital stay. Any Adverse effects observed were recorded in ‘Adverse Drug Event Reporting Form’ prepared by the CDSCO, Govt. of India. The data were evaluated for patient demography, types of TB, incidence of ADRs, onset and outcome of the ADRs. ADRs were also assessed for their causality and severity by using WHO-UMC criteria and Hartwig’s scale.
Results: Extra-pulmonary cases accounted for 32.2% of total TB cases. Among 224 cases of extra-pulmonary TB studied, 136 (60.7%) were males and 88 (39.3%) were females. Among these patients 82.2% completed treatment, 7.5% were defaulted, 9.9% died and 0.4% treatment failure. The most common reason for default was irregular treatment (29.5%) followed by alcohol abuse (23.5%). Among 224 patients of EPTB who were started on ATT as per DOTS, we noted ADR in 52 patients and 73 ADRs. Gastritis was the most common ADR (25%) followed by anorexia (14%) and skin reactions (9.6%) and multiple drug therapy was the major predisposing factor for these ADR’s.
Conclusions: Extra-pulmonary Tuberculosis accounts for 32.2% of the total cases studied. Treatment irregularities and alcohol abuse are the two most common reasons for default. On evaluation of the causality of ADRs, majority of them were found to be ‘possible’ by WHO-UMC and Naronjo’s causality assessment scale. The severity assessment of ADRs showed that 42% reactions were moderate and 58% were of the ‘mild’ nature.
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