Drug-induced Hepatitis (Abundance and Outcome During Course of Tuberculosis Treatment): Seven-year Study on 324 Patients with Positive Sputum in Iran

Abstract

Background:

Hepatotoxicity is a major concern during tuberculosis (TB) drug therapy. Its prevalence ranges from 1%-4% in developed countries to 11.5% in developing countries, and is even higher in countries such as India. Disease mortality is 5%, but can be prevented by early detection. This study reveals the revalence and outcome of drug-induced hepatitis (DIH) in positive sputum TB patients taking anti-TB drug therapy in Qazvin Province, Iran.

Materials and Methods:

This observational, descriptive, retrospective cross-sectional study was done on 324 patients (newly diagnosed cases) with positive sputum TB who took anti-TB drugs as the six months classic regimen Direct Observed Treatment Short course (DOTS) method of isoniazide + rifampin + pyrazinamide + ethambutol or streptomycin for two months followed by isoniazide + rifampin for four months, from 2004-2010.

Results :

The mean age of the cases was 42±12.1 years (mean±SD). A total of 194 cases (60%) were female and the remaining were male. DIH was seen in 16 cases (4.9%). The mean age of affected cases was 52 years. Liver enzymes had begun to rise 13-45 days after drug therapy (mean=25.25), the peak of the enzyme rise was 287-605 i.u. The enzyme level returned to normal after 14-43 days (mean=23.45) after discontinuation of the drugs. There was no mortality.

Conclusion :  

The prevalence of DIH in our study was 4.9%. Although it was seen more in females over 50, no statistically significant relations were found between DIH and sex or age of the patients. With baseline and biweekly liver enzyme checks and rapid drug discontinuation in raised cases, mortality was not observed.