中国药物警戒 ›› 2018, Vol. 15 ›› Issue (3): 176-180.

• 安全与合理用药 • 上一篇    下一篇

491例注射用脂溶性维生素严重不良反应分析

谢彦军1, 吴世福1, 田月洁1, 吴桂芝2, 许莉莉1, 董铎2   

  1. 1 山东省药品不良反应监测中心，山东 济南 250013；
    2 国家食品药品监督管理局药品评价中心，北京 100045
  • 收稿日期:2018-01-15 修回日期:2018-05-04 出版日期:2018-03-20 发布日期:2018-05-04
  • 通讯作者: 董铎，女，博士，主任药师，药品不良反应监测与评价。E-mail: dongduo@cdr..gov.cn
  • 作者简介:谢彦军，女，本科，副主任药师，药品不良反应监测与评价。

Analysis of 491 Cases of Serious Adverse Drug Reaction Cause by Fat-soluble Vitamins

XIE Yan-jun1, WU Shi-fu1, TIAN Yue-jie1, WU Gui-zhi2, XU Li-li1, DONG Duo2   

  1. 1 Adverse Drug Reaction Monitoring Centre of Shandong, Shandong Jinan 250013, China;
    2 Centre for Drug Reevaluation, CFDA, Beijing 100045, China
  • Received:2018-01-15 Revised:2018-05-04 Online:2018-03-20 Published:2018-05-04

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摘要： 目的 探讨注射用脂溶性维生素致严重药品不良反应（ADR）特点和风险因素，为临床安全用药提供参考。方法对山东省ADR数据库中491份注射用脂溶性维生素严重ADR报告进行统计分析。结果 注射用脂溶性维生素严重ADR可累及多个系统，过敏反应是其主要不良反应，严重的可导致过敏性休克。药品说明书缺少相关安全性提示信息；临床用药存在超适应证用药现象。结论 生产企业应开展注射用脂溶性维生素安全性监测，及时更新药品说明书安全性信息内容，提示用药风险；临床应严格按照适应证及用法用量合理选择和使用药品以降低风险。

关键词: 注射用脂溶性维生素, 不良反应, 分析

Abstract: Objective To explore the general characteristics and risk factors of serious adverse drug reaction (ADR) induced by fat-soluble vitamin for injection, so as to provide reference for rational and safe clinical drug use. Methods 491 serious ADR reports of fat-soluble vitamin for injection were collected based on Shandong adverse drug reaction database and the data were analyzed statistically. Results Serious adverse reactions of fat-soluble vitamins for injection could affect multiple systems. Allergic reactions were the main adverse reactions, and severe ones could lead to anaphylactic shock risk in clinic. Conclusion The manufacturer should carry out the safety monitoring of fat-soluble vitamin for injection, update the safety information contents of the drug instruction and warn drug risk in time. Drugs should be used reasonably following the indications, and dosage and administration to reduce the risk of ADRs.

Key words: fat-soluble vitamin for injection, adverse reaction, analysis

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