Comparison of adverse drug reactions of antitubercular drugs in category 1 tuberculosis patients between daily and intermittent regimen and its impact on outcome

Abstract

Aim of the present study was to compare the ADRs in patients taking antitubercular treatment under RNTCP regimen between intermittent treatment & daily therapy and to know the impact of ADRs on outcome of treatment in patients. 100 patients having pulmonary tuberculosis were included in the study who were taking the treatment nof tuberculosis as per criteria, guidelines and various regimens of RNTCP. They were observed in DOTS group (group 1, intermittent) and in the group receiving treatment on OPD basis (group 2, daily treatment) for various ADRs and relevant findings were recorded during each clinical visit of the patients. The impact of ADRs on outcome of treatment was seen in the form of cured, relapsed, treatment failure, defaulted and alteration in therapy. 39 patients developed 1 or more ADRs out of 100 patients. The incidence of ADRs was more in group 2 (27, 54%) as compared to group 1(12, 24%) (p<0.01). Out of patients in group 1with ADRs & without ADRs , cure occurred in 25% & 81.57%, defaulters were 33.33% & 2.63%, failure of treatment occurred in 8.33% & 2.63%, relapse occurred in 8.33% & 13.15%, alteration of therapy required in 25% & 0% respectively (p<0.05). Out of patients in group 2 with ADRs & without ADRs , cure occurred in 55.55% & 91.3%, defaulters were 22.22% & 4.34%, failure of treatment occurred in 3.7% & 0%, relapseoccurred in 11.11% & 4.34%, alteration of therapy required in 7.4% & 0% respectively (p<0.05). ADRs in daily treatment group (group 2) are significantly more as compared to intermittent group (group 1). Patients without ADRs have significantly better outcome as compared to patients with ADRs in both the groups Key words: Pulmonary tuberculosis, daily, intermittent, adverse drug reaction, impact, outcome