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Adverse drug reactions observed during DOTS
V K Dhingra1, S Rajpal, Nishi Aggarwal
1New Delhi Tuberculosis Centre, Jawaharlal Nehru Marg, New Delhi-110 002.
Adverse drug reactions occurred in 8.37% of patients on Directly Observed Treatment, Short-course (DOTS) for tuberculosis. Gastrointestinal issues like nausea and vomiting were most common, with most reactions appearing early in treatment.
Area of Science:
- * Pharmacovigilance
- * Public Health
- * Infectious Diseases
Background:
- * Tuberculosis remains a significant global health challenge.
- * Directly Observed Treatment, Short-course (DOTS) is a key strategy for tuberculosis control under the Revised National Tuberculosis Control Programme (RNTCP).
- * Understanding adverse drug reactions (ADRs) is crucial for patient adherence and treatment success.
Purpose of the Study:
- * To determine the incidence and profile of adverse drug reactions in patients treated with DOTS.
- * To identify common ADRs and their timing during treatment.
- * To assess the impact of ADRs on treatment interruption.
Main Methods:
- * Retrospective study of 1195 patients treated between January 2002 and June 2003.
- * Detailed investigation of patients with ADRs using personal interviews and semi-structured questionnaires.
- * Analysis of ADR types, frequency, timing, and effect on treatment.
Main Results:
- * 8.37% of patients experienced adverse drug reactions.
- * Gastrointestinal reactions (53%), including nausea and vomiting, were most frequent.
- * Other common ADRs included general aches/pains (35%), giddiness (27%), skin rash/itching (17%), and arthralgia (11%). Hepatotoxicity was rare (1%).
- * Most ADRs (67%) occurred within the first four weeks of treatment.
- * Treatment interruption due to ADRs was minimal (0.25%).
Conclusions:
- * Adverse drug reactions are relatively uncommon in patients undergoing DOTS therapy for tuberculosis.
- * Gastrointestinal disturbances are the predominant ADRs, typically manifesting early in the treatment course.
- * DOTS therapy is generally well-tolerated, with minimal impact on treatment continuity.
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