中国药物警戒 ›› 2015, Vol. 12 ›› Issue (8): 491-493.

• 药械安全性研究 • 上一篇    下一篇

208例骨瓜提取物注射剂严重不良反应报告分析

沈晓华1, 罗凌凤2, 黄亦彬1   

  1. 1. 福建省药品不良反应监测中心,福建 福州 350003;
    2. 福建医科大学,福建 福州 350108
  • 收稿日期:2015-09-02 修回日期:2015-09-02 出版日期:2015-08-08 发布日期:2015-09-02
  • 作者简介:沈晓华,女,硕士,药师,药品安全监测。

Analysis of 208 Cases of Serious Adverse Drug Reactions Induced by Gugua Extracts Injection

SHEN Xiao-hua1, LUO Ling-feng2, HUANG Yi-bin1   

  1. 1. Center for ADR Monitoring of Fujian, Fujian Fuzhou 350003, China;
    2. Fujian Medical University, Fujian Fuzhou 350108, China
  • Received:2015-09-02 Revised:2015-09-02 Online:2015-08-08 Published:2015-09-02

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摘要： 目的 探讨骨瓜提取物注射剂致严重药品不良反应的规律及特点。方法 采用回顾性研究方法,对208份骨瓜提取物注射剂的严重不良反应报告进行统计分析。结果 骨瓜提取物注射剂严重不良反应主要表现为过敏性休克、过敏样反应、寒战、呼吸困难和发热等;严重不良反应多在30 min内发生,其中过敏性休克主要集中在15 min内发生。结论 有必要对骨瓜提取物注射剂说明书进行修改和完善。

关键词: 骨瓜提取物, 严重不良反应, 过敏性休克

Abstract: Objective To explore the characters of the serious adverse reactions caused by Gugua extracts injection. Methods 208 reports of the serious adverse reactions caused by Gugua extracts injection were analyzed via retrospective study. Results Gugua extracts injection may lead to serious adverse reactions such as anaphylactic shock, anaphylactoid reaction,rigors,dyspnea,fever, etc. The serious adverse reactions occurred within 30 min, and anaphylactic shock occurred within 15 min. Conclusion It is necessary to re-evaluate the risk of serious adverse reactions caused by Gugua extracts injection and modify the drug instructions on this basis.

Key words: Gugua extracts, serious adverse reactions, anaphylactic shock

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