中国药物警戒 ›› 2019, Vol. 16 ›› Issue (11): 675-677.
DOI: 10.19803/j.1672-8629.2019.11.07

• 安全性评价与合理用药 • 上一篇    下一篇

天麻素注射剂安全性风险的分析及思考

王涛, 王丹   

  1. 国家药品监督管理局药品评价中心,北京 100022
  • 收稿日期:2019-11-27 修回日期:2019-11-27 出版日期:2019-11-20 发布日期:2019-11-27
  • 作者简介:王涛,男,博士,副研究员,神经药理学、药品不良反应监测与评价。
  • 基金资助:
    国家科技重大专项项目（2017ZX09101001-001-003）：药品再评价政策法规及实施策略研究

Risks Analysis of Gastrodin Injection

WANG Tao, WANG Dan   

  1. Center for Drug Reevaluation, NMPA, Beijing 100022, China
  • Received:2019-11-27 Revised:2019-11-27 Online:2019-11-20 Published:2019-11-27

PDF (PC)

194

摘要： 目的 分析天麻素注射剂的安全性风险,为临床合理用药提供参考。方法 对我国药品不良反应监测数据库、国内外文献数据库中的不良反应报告及国内风险控制措施等相关资料进行整理与分析。结果 天麻素注射剂临床使用过程中存在严重过敏反应及儿童用药相关风险。结论 应加强天麻素注射剂的临床应用监测,及时完善产品说明书,促进药品的合理使用。

关键词: 天麻素, 过敏反应, 说明书, 儿童用药

Abstract: Objective To analyze the risk related to gastrodin injection in China in order to provide reference for clinical rational drug use. Methods The individual cases of adverse drug reactions in China Adverse Drug Reaction Database and domestic and foreign literature, as well as risk management measures taken in China were analyzed. Results When gastrodin injection was used clinically, there were risks associated with pediatric use and severe allergic reactions. Conclusion We should strengthen the clinical application monitoring of gastrodin injection, update the drug labeling without delay and promote the rational use of medicines.

Key words: gastrodin, allergic reaction, labeling, pediatric use

中图分类号: