Chinese Journal of Pharmacovigilance ›› 2012, Vol. 9 ›› Issue (8): 460-463.

• Orginal Article • Previous Articles     Next Articles

Systematic Review of Risk Factors of Oral Ketoconazole Hepatotoxicity

NIE Xiao-lu1, TAO Qing-mei1, ZHAN Si-yan1, WANG Dan2, WU Gu-izhi2, CHENG Gang2*   

  1. 1 Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing 100191, China;
    2 Center for Drug Reevaluation, SFDA, Beijing 100045, China
  • Received:2012-06-18 Online:2012-08-10 Published:2015-08-07

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Abstract: ObjectiveTo study risk factors of oral ketoconazole hepatotoxicity. MethodSearching articles using relative terms about ketoconazole, oral treatment published on PubMed, Medline, CBM, CNKI, VIP, Wanfang and many other databases by Nov. 2011. Picking up the basic information, method features, interventions and adverse reactions when the studies were included, fixed models were used for the final results'meta analysis. ResultsThe included studies were 195. Subgroup analyze according to dose and duration does not yet obviously indicate that the relation between incidence of liver damage and dose and time for medication; Children's incidence of liver injury was 2.2%(95% CI: 0.7%~6.6%), while that of elderly people over the age of 60 was 14.0%(95% CI: 4.9% ~34.3%); Using oral ketoconazole for treatment beyond the provisions of the instructions got a higher incidence of liver damage, was 5.5%(95% CI: 4.3%~7.0%). ConclusionThe risk factors of oral ketoconazole hepatotoxicity were the elderly and the ultra-manual usage, failed to clear the relation between incidence of hepatotoxicity and dose and time for medication.

Key words: ketoconazole, oral treatment, hepatotoxicity, risk factors, systematic review