中国药物警戒 ›› 2012, Vol. 9 ›› Issue (8): 460-463.

• 循证评价 • 上一篇    下一篇

酮康唑口服制剂致肝损害风险因素的系统评价

聂晓璐1, 陶庆梅1, 詹思延1, 王丹2, 吴桂芝2, 程刚2*   

  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 出版日期:2012-08-10 发布日期:2015-08-07
  • 通讯作者: 程刚,男,工程师,药品不良反应监测与评价。E-mail：chenggang@cdr.gov.cn
  • 作者简介:聂晓璐,女,在读硕士,循证医学。

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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摘要： 目的了解国内外酮康唑口服制剂所致肝损害发生风险因素。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。按照剂量和疗程分组分析,尚不能认为肝损害的发生率与剂量和服药时间有明显的关系;儿童肝损伤发生率为2.2%（95%CI:0.7%~6.6%）,60岁以上老年人肝损伤发生率为14.0%（95%CI:4.9%~34.3%）;使用酮康唑口服制剂治疗超出其规定说明书适应证用药时,肝损害的发生率较高,为5.5%（95%CI:4.3%~7.0%）。结论酮康唑口服制剂所致肝损害发生的可能风险因素是老年、超说明书适应证使用,未能明确其与剂量和服药时间的关系。

关键词: 酮康唑, 口服制剂, 肝损害, 风险因素, 系统评价

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