中国药物警戒 ›› 2021, Vol. 18 ›› Issue (6): 575-578.
DOI: 10.19803/j.1672-8629.2021.06.17

• 安全与合理用药 • 上一篇    下一篇

丹参川芎嗪注射液安全风险分析与思考

许先兴1, 杨静文2, 苗会青3   

  1. 1国家药品监督管理局药品评价中心,北京 100028;
    2中国人民解放军总医院第五医学中心,北京 100039;
    3海南省药品不良反应监测中心,海南 海口 570216
  • 收稿日期:2020-05-04 出版日期:2021-06-15 发布日期:2021-07-02
  • 作者简介:许先兴,男,博士,副主任药师,药代动力学与药品不良反应监测。
  • 基金资助:
    重大新药创制国家科技重大专项2017年度（2017ZX09101001-007）

Potential Risks of Salviae Miltiorrhizae and Ligustrazine Injection

XU Xianxing1, YANG Jingwen2, MIAO Huiqing3   

  1. 1Center for Drug Reevaluation, NMPA, Beijing, 100028, China;
    2The Fifth Medical Center of PLA General Hospital, Beijing,100039, China;
    3Hainan Center for Adverse Drug Reaction Monitoring, Haikou Hainan 570216, China
  • Received:2020-05-04 Online:2021-06-15 Published:2021-07-02

PDF (PC)

106

摘要： 目的 探讨丹参川芎嗪注射液临床应用潜在风险,为临床合理用药提供参考。方法 通过分析国家药品不良反应监测数据及相关文献资料,结合临床调研情况,分析丹参川芎嗪注射液临床应用特点及潜在风险。结果 丹参川芎嗪注射液在我国临床科室使用广泛,近年来其不良反应报告数量和严重报告比例均呈现明显上升趋势,超适应证、超剂量用药等现象比较普遍,增加了患者发生不良反应的风险。结论 临床医务人员应严格按照适应证合理规范使用丹参川芎嗪注射液,加强对患者给药期间的监护,密切关注可能出现的严重过敏反应特别是过敏性休克风险。

关键词: 丹参川芎嗪注射液, 过敏反应, 药品不良反应

Abstract: Objective To investigate the potential risks of Salviae Miltiorrhizae and Ligustrazine injection so as to promote rational use in clinical practice. Methods The valid data of Salviae Miltiorrhizae and Ligustrazine injection was retrieved from the database of National Center for Adverse Drug Reaction Monitoring and literature. The clinical applications and potential risks of this injection were analyzed. Results Salviae Miltiorrhizae and Ligustrazine injection was widely used in clinic. Both the number of adverse reactions reported and the proportion of serious reports were trending up. Additionally, off-label use and overdose were common, which might increase the incidence of adverse reactions in patients. Conclusion Salviae Miltiorrhizae and Ligustrazine injection should be used in accordance with indications. Meanwhile,close attention should be paid to the risk of serious allergic reactions, especially anaphylactic shock.

Key words: Salviae Miltiorrhizae and Ligustrazine, allergic reaction, adverse drug reaction

中图分类号: