中国药物警戒 ›› 2018, Vol. 15 ›› Issue (2): 90-93.

• 法规与管理研究 • 上一篇    下一篇

美国更新氟喹诺酮类药品说明书评价回顾与分析

刘翠丽, 吴桂芝*, 冯红云, 李岚   

  1. 国家食品药品监督管理总局药品评价中心，北京 100045
  • 收稿日期:2017-10-26 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: 吴桂芝，女，博士，主任药师，药品不良反应监测与评价。E-mail:wuguizhi@cdr-adr.org.cn
  • 作者简介:刘翠丽，女，硕士，副主任药师，药品不良反应监测与评价。

Review and Analysis of Evaluation of FDA for Updating Fluoroquinolones Label

LIU Cui-li, WU Gui-zhi*, FENG Hong-yun, LI Lan   

  1. Center for Drug Reevaluation, CFDA, Beijing 100045, China
  • Received:2017-10-26 Revised:2018-03-28 Online:2018-02-20 Published:2018-03-28

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摘要： 目的 了解美国更新氟喹诺酮类药品说明书的评价过程及内容，为我国药品上市后风险获益评价及更好的药品监管提供借鉴。方法 系统介绍美国对氟喹诺酮类药品开展评价的背景、内容及结果，分析美国对氟喹诺酮类药品评价及监管的思路与方法。结果 美国此次对氟喹诺酮类药品的评价，不仅是对此类药品安全性的全面评价，还针对其涉及的3个适应证开展了风险效益评估，对用药安全具有重要意义。结论 关注国外先进的药品上市后风险获益评价及监管措施，可为我国药品上市后评价与监管提供思路和借鉴。

关键词: 氟喹诺酮, 说明书, 评价

Abstract: Objective To study the evaluation work of FDA updated fluoroquinolone label and to provide reference for the post-marketing evaluation of risk-benefit of drug and better management in China. Methods This article introduced the background, contents and results of the evaluation of the fluoroquinolones to analyze the regulatory thinking and methods of drug management in the United States. Results This work is not only a comprehensive evaluation of the safety of fluoroquinolones, but also carries out risk-benefit assessment for three indications, which is of great significance for the safety of fluoroquinolones. Conclusion Paying attention to the means of foreign advanced drug management can provide ideas and reference for the post-marketing evaluation of drugs in China.

Key words: fluoroquinolone, label, review

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