中国药物警戒 ›› 2021, Vol. 18 ›› Issue (2): 174-177.
DOI: 10.19803/j.1672-8629.2021.02.16

• 安全与合理用药 • 上一篇    下一篇

注射用七叶皂苷钠安全性风险分析及思考

于一1, 王慧2, 刘红亮1, 王春婷1,*   

  1. 1国家药品监督管理局药品评价中心,北京 100022;
    2湖北省药品不良反应监测中心,湖北 武汉 430071
  • 收稿日期:2020-09-28 修回日期:2021-02-26 出版日期:2021-02-15 发布日期:2021-02-26
  • 通讯作者: *王春婷,女,硕士,主任药师,药品不良反应监测与评价。E-mail：wangchunting@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 and Consideration on Risk of Sodium Aescinate for Injection

YU Yi1, WANG Hui2, LIU Hongliang1, WANG Chunting1,*   

  1. 1Center for Drug Reevaluation, NMPA, Beijing 100022, China;
    2Hubei Center for ADR Monitoring, Wuhan Hubei 430071, China
  • Received:2020-09-28 Revised:2021-02-26 Online:2021-02-15 Published:2021-02-26

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摘要： 目的 分析注射用七叶皂苷钠的安全性风险,为其安全使用提供参考。方法 对国家药品不良反应监测数据库、国内文献中不良反应报告及药品监管部门采取风险控制措施等相关资料信息进行整理与分析。结果 注射用七叶皂苷钠可致皮疹、瘙痒、静脉炎、过敏性休克、肝损害等不良反应;儿童和老年人也存在用药风险;临床应用需注意并做好相关防治措施。结论 为防控注射用七叶皂苷钠在临床使用中的安全性风险,药品上市许可持有人应对已识别的风险及时采取修改说明书等风险控制措施,主动开展上市后研究。医疗机构应加强合理用药,避免不良反应的发生。药品不良反应监测机构应持续加强不良反应监测工作,警示用药风险,保证公众用药安全。

关键词: 注射用七叶皂苷钠, 药品不良反应, 文献分析, 监管措施

Abstract: Objective To analyze the risk of Sodium Aescinate for injection, so as to provide reference for clinical use safety. Methods The individual ADR (adverse drug reaction) cases in China adverse drug reaction database, domestic literatures, and the risk management measures by NMPA were analyzed. Results Data analysis showed that, the ADR of the Rash, pruritus, phlebitis, anaphylactic shock, liver damage et al. induced by Sodium Aescinate for injection and the risk of medication for children and the elderly should be concerned in clinical use and take relevant prevention and control measures. Conclusion Marketing authorization holders should take risk control measures such as revising the drug instructions for the identified risks and actively carry out post market study; hospitals should strengthen the rational use of drugs to avoid the occurrence of adverse reactions; institutions of monitoring and evaluation of adverse drug reactions should continuously strengthen the monitoring of adverse reactions to ensure the safety of drug users.

Key words: Sodium Aescinate for injection, adverse drug reaction, literature analysis, regulatory measure

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