中国药物警戒 ›› 2021, Vol. 18 ›› Issue (7): 678-682.
DOI: 10.19803/j.1672-8629.2021.07.17

• 安全与合理用药 • 上一篇    下一篇

银杏叶片等口服制剂安全性风险的分析及思考

于一1, 黄倩倩2, 肖爱丽1,*   

  1. 1国家药品监督管理局药品评价中心,北京 100022;
    2江苏省药品不良反应监测中心,江苏 南京 210002
  • 收稿日期:2020-12-21 出版日期:2021-07-15 发布日期:2021-07-23
  • 通讯作者: *肖爱丽,女,主任药师,药品不良反应监测与评价。E-mail：xiaoaili@cdr-adr.org.cn
  • 作者简介:于一,女,硕士,工程师,药品不良反应监测与评价。

Analysis of Safety Risks of Ginkgo Biloba Tablets and Other Oral Preparations

YU Yi1, HUANG Qianqian2, XIAO Aili1,*   

  1. 1Center for Drug Reevaluation, NMPA, Beijing 100022, China;
    2Jiangsu Center for ADR Monitoring, Nanjing, Jiangsu 210002, China
  • Received:2020-12-21 Online:2021-07-15 Published:2021-07-23

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摘要： 目的 分析银杏叶片等口服制剂的安全性风险,为其安全使用提供参考。方法 对国家药品不良反应监测系统、国内外文献中的不良反应/事件、国内外采取的风险控制措施等相关资料进行整理与分析。结果 银杏叶片等口服制剂临床使用中可能发生涉及多个系统-器官的不良反应/事件;联合用药存在发生药物相互作用的风险;在药品的生产环节对游离槲皮素、山柰素、异鼠李素等物质的控制存在一定风险。结论 为防控银杏叶片等口服制剂在临床使用中的安全性风险,医疗机构应加强临床合理用药,药品上市许可持有人应履行药物警戒主体责任,药品不良反应监测评价技术机构应加强不良反应监测。

关键词: 银杏叶片, 口服制剂, 药品不良反应, 文献分析, 监管措施

Abstract: Objective To analyze the risks of Ginkgo Biloba tablets and other oral preparations, and to provide reference for safe clinical use. Methods The adverse reactions/events reported by China adverse drug reaction monitoring systems and by domestic and foreign literature, as well as risk management measures taken by drug regulatory authorities were analyzed. Results Adverse reactions/events involving multiple systems / organs might occur in clinical use of Ginkgo Biloba tablets and other oral preparations. There was the risk of drug interactions in combination therapies, and there were also some risks to the control of free quercetin, kaempferol and isorhamnetin in the course of production. Conclusion In order to prevent and control the safety risks posed by Ginkgo Biloba tablets and other oral preparations in clinical use, hospitals should strive to ensure clinical rational drug use, marketing authorization holders should fulfill their main responsibility of pharmacovigilance, and institutions of monitoring and evaluation of adverse drug reactions should strengthen the monitoring of adverse reactions.

Key words: Ginkgo Biloba tablets, oral preparations, adverse drug reactions, literature analysis, regulatory measures

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