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Free Content The influence of risk factors on the severity of anti-tuberculosis drug-induced hepatotoxicity

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BACKGROUND: Hepatotoxicity is one of the most serious adverse effects of anti-tuberculosis drugs (ATD). Although many risk factors have been associated with ATD-induced hepatotoxicity, their influence on hepatitis severity has not been studied systematically.

OBJECTIVES: To evaluate whether the presence of hepatotoxicity risk factors (advanced age, chronic liver disease, abuse of alcohol or other drugs or malnutrition) influences the severity of ATD-induced hepatotoxicity.

DESIGN: A prospective cohort study of 471 active tuberculosis patients treated with isoniazid, rifampicin and pyrazinamide and followed in a tuberculosis clinic between January 1998 and July 2002. Incidence of hepatotoxicity and its severity according to the presence or absence of ATD-induced hepatitis risk factors was evaluated.

RESULTS: The incidence of ATD-induced hepatotoxicity (serum transaminase >3 × the upper limit of normal [ULN]) was 18.2% (42/231 patients) in the risk factor group and 5.8% (14/240 patients) in the non-risk factor group (OR 3.5; 95%CI 1.9–6.7; P < 0.001). Severe hepatotoxicity (transaminase >10 × ULN) occurred in 6.9% (16/231) of the risk factor group and in 0.4% (1/240) (OR 17.7; 95%CI 2.3–135; P < 0.001) of the group without risk factors.

CONCLUSIONS: ATD-induced hepatitis is significantly more frequent and more severe in patients with hepatotoxicity risk factors.
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Keywords: anti-tuberculosis drugs; risk factors; severe hepatotoxicity

Document Type: Regular Paper

Affiliations: 1: Tuberculosis Unit, Department of Pneumology, Xeral-Cíes University Hospital, Vigo, Pontevedra, Spain 2: Department of Internal Medicine, Xeral-Cíes University Hospital, Vigo, Pontevedra, Spain 3: Department of Clinical Analysis, Nicolás Peña Hospital, Vigo, Pontevedra, Spain

Publication date: 01 December 2004

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  • The International Journal of Tuberculosis and Lung Disease publishes articles on all aspects of lung health, including public health-related issues such as training programmes, cost-benefit analysis, legislation, epidemiology, intervention studies and health systems research. The IJTLD is dedicated to the continuing education of physicians and health personnel and the dissemination of information on tuberculosis and lung health world-wide.

    Certain IJTLD articles are selected for translation into French, Spanish, Chinese or Russian. They are available on the Union website

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