中国药物警戒 ›› 2018, Vol. 15 ›› Issue (2): 83-89.

• 利巴韦林临床使用调查分析专栏 • 上一篇    下一篇

利巴韦林儿童应用风险分析与建议

李清芳1,2, 刘欢3, 张丹丹3, 杨悦3,4,*, 张惠霞5, 夏旭东5, 刘超5   

  1. 1 开封市食品药品检验所，河南 开封 475000;
    2 开封市药品不良反应监测中心，河南 开封 475000;
    3 沈阳药科大学工商管理学院，辽宁 沈阳 110016;
    4 沈阳药科大学国际食品药品政策与法律研究中心，辽宁 沈阳 110016;
    5 河南省食品药品评价中心，河南 郑州 450018
  • 收稿日期:2017-11-23 修回日期:2018-03-28 出版日期:2018-02-20 发布日期:2018-03-28
  • 通讯作者: 杨悦，女，博士?博导，药事法规与药品政策。E-mail：yyue315@vip.126.com
  • 作者简介:李清芳，女，副主任药师，药品检验与药品安全监测。

Analysis and Suggestions on Risk of Ribavirin in Children

LI Qing-fang1,2, LIU Huan3, ZHANG Dan-dan3, YANG Yue3,4,*, ZHANG Hui-xia5, XIA Xu-dong5, LIU Chao5   

  1. 1 Kaifeng Institute of Food and Drug Control, Henan Kaifeng 450000, China;
    2 Center for ADR Monitoring of Kaifeng, Henan Kaifeng 450000, China;
    3 School of Business Administration, Shenyang Pharmaceutical University, Liaoning Shenyang 110016, China;
    4 International Food & Drug Policy and Law Research Center, Liaoning Shenyang Pharmaceutical University, Liaoning Shenyang 110016, China;
    5 Henan Food and Drug Evaluation Center, Henan Zhengzhou 450018, China
  • Received:2017-11-23 Revised:2018-03-28 Online:2018-02-20 Published:2018-03-28

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摘要： 目的 通过比较国内外利巴韦林批准情况及药品说明书等，并对某省利巴韦林儿童药品不良反应（ADR）报告数据挖掘，分析我国儿童利巴韦林临床应用风险来源，以期为该药说明书修改、临床应用及监管等提供建议。方法 比较分析国内外利巴韦林批准信息、使用情况及药品说明书；采用回顾性方法对某省2003年1月至2016年12月利巴韦林儿童ADR报告数据分析。结果 国内外利巴韦林批准剂型、适应证差异明显，我国利巴韦林儿科临床应用中联合用药不当、超适应证使用等不合理用药现象严重。结论 建议修订完善药品说明书，对利巴韦林未批适应证和未批剂型予以关注，规范其儿科临床应用。

关键词: 利巴韦林, 批准及使用, 说明书比较, 风险分析, 儿童

Abstract: Objective Through comparatively analyzing the approval, application and instructions of ribavirin at home and abroad, to conduct the risk analysis of domestic children ribavirin clinical use based on the ribavirin's children ADR report data in a certain province, so as to provide suggestions on the modification of instructions, clinical application, regulation and so on. Methods The risk of ribavirin was analyzed by means of comparing ribavirin's approval, application and instructions at home and abroad,and analyzing ribavirin's children ADR reports collected by a certain province from January 2003 to December 2016. Results The approval and application of ribavirin were different significantly between China and abroad, the phenomenons of irrational drug combination and off-label use are common during clinical application in children. Conclusion It is suggested that regulatory authority, manufactures and healthcare providers should pay attention to unapproved indications and dosage form of ribavirin, while revising and improving instruction for more standardized application .

Key words: ribavirin, approval and clinical application, comparison of instructions, risk analysis, children

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