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Recurrent Drug-Induced Hepatitis in TuberculosisComparison of Two Drug Regimens

Shamaei, Masoud MD; Mirsaeidi, Mehdi MD; Baghaei, Parvaneh MD, PhD; Mosaei, Hamed MS; Marjani, Majid MD; Tabarsi, Payam MD

American Journal of Therapeutics:
doi: 10.1097/MJT.0000000000000218
Original Articles

Drug-induced hepatitis (DIH) is one of the major complications among the treatment of patients with tuberculosis (TB); it might even be fatal. This study tries to address the recurrence of DIH with 2 anti-TB regimens. In the retrospective study from 2007 to 2010, 135 TB patients with DIH who were older than 16 years were entered to study. The patients with DIH were randomly treated with a regimen, including isoniazid, rifampin, and ethambutol, plus either ofloxacin or pyrazinamide. The patients were reviewed for occurrence of recurrent DIH. Cure and completed treatment were considered as acceptable treatment outcomes, whereas default of treatment, treatment failure, and death were considered to be unacceptable outcomes. Therefore, 135 subjects with DIH were reviewed, and 23 patients (17%) experienced recurrence of hepatitis (19 cases in the ofloxacin group and 4 cases in the pyrazinamide group). There is no significant difference in recurrence of hepatitis between these 2 groups (P = 0.803). An acceptable outcome was observed in 95 patients (70.4%), and an unacceptable outcome was seen in 14 cases (10.3%). There was no significant difference in outcomes between these 2 regimens (P = 0.400, odds ratio = 1.62, 95% confidence interval, 0.524–4.98). The results of our study suggest that ofloxacin-based anti-TB regimen does not decrease the risk of recurrent DIH. Therefore, adding ofloxacin in the case of DIH is not recommended.

Author Information

1Department of Pathology, Clinical Tuberculosis and Epidemiology Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran;

2Division of Pulmonary Care, University of Illinois at Chicago, Chicago, IL; and

3Unit Bacterium-Host Interactions, The Centre for Bacterial Cell Biology, Baddiley-Clark Building, Medical School, Newcastle University, Newcastle, UK.

Address for correspondence: Department of Infectious Diseases, Clinical Tuberculosis and Epidemiology Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Masih Daneshvari Hospital, Shahid Beheshti University of Medical Sciences, Tehran, 19556 Iran. E-mail:

Mehdi Mirsaeidi was supported by NIH grant 5 T32 HL 82547-7.

The authors have no conflicts of interest to declare.

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