中国药物警戒 ›› 2012, Vol. 9 ›› Issue (12): 719-722.

• 循证评价 • 上一篇    下一篇

酮康唑口服制剂不良反应总体情况及肝损害发生率系统综述

陶庆梅1,聂晓璐1,程刚2,王丹2,吴桂芝2,詹思延1*   

  1. 1.北京大学公卫学院流行病与卫生统计学系,北京 100191；
    2.国家食品药品监督管理局药品评价中心,北京 100045
  • 收稿日期:2012-06-18 修回日期:2016-03-09 出版日期:2013-12-08 发布日期:2016-03-09
  • 通讯作者: 詹思延,女,教授,博士生导师,循证医学与药物流行病学。E-mail：siyan-zhan@bjmu.edu.cn
  • 作者简介:陶庆梅,女,在读硕士,药物流行病学。

Systematic Review of Oral Ketoconazole Adverse Reactions and Hepatotoxicity Incidence

TAO Qing-mei1, NIE Xiao-lu1 ,CHENG Gang2, WANG Dan2, WU Gui-zhi2, ZHAN Si-yan1*   

  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 Revised:2016-03-09 Online:2013-12-08 Published:2016-03-09

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摘要： 目的 了解国内外酮康唑口服制剂不良反应尤其是肝损害发生情况。方法 2011年11月利用酮康唑有关药品名称、口服制剂等作检索词检索 PUBMED、MEDLINE、中国生物医学文献数据库（CBM）、中国期刊全文专题数据库（CNKI）、中国科技期刊数据库（VIP）及万方数据库等多个数据库。对于符合纳入标准的文献,提取基本信息、方法学特征、干预措施和不良反应发生情况等信息。用固定效应模型对各个研究的结果进行Meta分析。结果纳入分析的文献共 195篇。合并结果显示,使用酮康唑口服制剂后发生不良反应,排在前3位的类型依次是胃肠道不良反应（44.5%）；神经及精神系统（13.8%）和肝损伤（11.0%）；按照不同研究类型合并统计的肝损伤不良反应发生率在 3.1%~4.1%之间。结论 酮康唑口服制剂不良反应发生类型较多,涉及全身多系统,其中肝损害不良反应发生率较高（3.1%~4.1%）,但由于绝大多数文献仅以肝酶升高为报告指标,未能明确各种严重型肝损害发生率或比例。由于文献质量及发表偏倚等问题,所得结论在推广时需谨慎。

关键词: 酮康唑, 口服制剂, 不良反应, 肝损害, 系统综述

Abstract: Objective To study the oral ketoconazole adverse reactions in the world, especially the hepatotoxicity. Methods Searching articles using relative terms about ketoconazole, oral administration published on PUBMED, MED LINE, 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. Results The number of included studies was 195. The top three adverse reactions were intestinal adverse reactions(44.5%), neurological and psychiatric adverse reactions(13.8%), hepatotoxicity(11.0%). The hepatotoxicity incidence proportion was 3.1% ~4.1%. Conclusion Many kinds of oral ketoconazole adverse reactions were observed, relating to all systems, the hepatotoxicity proportion was high(3.1%~4.1%). Because elevated liver enzymes were the most common reporting markers, severe liver injure proportion couldn't be measured. When generalizing the Results one should consider the study qualities and publication bias.

Key words: ketoconazole, oral administration, adverse reaction, hepatotoxicity, systematic review

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