中国药物警戒 ›› 2018, Vol. 15 ›› Issue (10): 600-602.

• 法规与管理研究 • 上一篇    下一篇

复方脂溶性维生素注射剂安全风险分析和思考

许先兴1, 杨静文2, 吴桂芝1, 谢彦军3, 崔小康3, 许莉莉3   

  1. 1国家食品药品监督管理总局药品评价中心,北京 100045;
    2解放军总医院第一附属医院,北京 100048;
    3山东省药品不良反应监测中心,山东 济南 250013
  • 收稿日期:2018-08-27 修回日期:2018-11-27 出版日期:2018-10-20 发布日期:2018-11-27
  • 作者简介:许先兴,男,博士,主管药师,药代动力学与药品不良反应监测。
  • 基金资助:
    国家科技重大专项-重大新药创制“药物一致性评价关键技术与标准研究”课题（2017ZX09101001）：化学注射剂一致性评价的探索研究

Analysis and Consideration on Potential Risk of Fat-soluble Vitamin Injections

XU Xianxing1, YANG Jingwen2, WU Guizhi1, XIE Yanjun3, CUI Xiaokang3, XU LIli3   

  1. 1Center for Drug Reevaluation, CFDA, Beijing 100045, China;
    2The First Affiliated Hospital of PLA General Hospital, Beijing 100048, China;
    3Shandong Center for Adverse Drug Reaction Monitoring, Shandong Jinan 250013, China
  • Received:2018-08-27 Revised:2018-11-27 Online:2018-10-20 Published:2018-11-27

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摘要： 目的 探讨国内复方脂溶性维生素注射剂临床应用的潜在风险,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开展临床回顾性研究,分析我国复方脂溶性维生素注射剂临床应用特点及潜在风险。结果 复方脂溶性维生素注射剂在我国临床广泛使用,近年来严重不良反应比例呈现上升趋势,不合理、不规范使用现象比较普遍,增加了患者发生不良反应的风险。结论 复方脂溶性维生素注射剂容易导致过敏反应,临床应严格按照适应证使用,在给药期间加强监护,密切关注其严重过敏反应、特别是过敏性休克的风险。

关键词: 脂溶性维生素注射剂, 过敏反应, 药品不良反应

Abstract: Objective To investigate the potential risks of fat-soluble vitamin injections so as to promote rational use of these products in clinical practice. Methods The valid data of fat-soluble vitamin injections were retrieved from the database of National Center for Adverse Drug Reaction Monitoring and clinical retrospective study, the clinical application characteristics and potential risks were analyzed. Results Fat-soluble vitamin injections are widely used in clinic, and the proportion of serious adverse reaction has shown an upward trend. Additionally, unreasonable and irregular use is common, which may increase the risk of adverse reactions in patients. Conclusion Fat-soluble vitamin injections 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: fat-soluble vitamin injections, allergic reaction, adverse drug reaction

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