中国药物警戒 ›› 2012, Vol. 9 ›› Issue (1): 47-50.

• 药品不良反应监测 • 上一篇    下一篇

412 例细辛脑注射液ADR/ADE 报告分析

夏旭东，龚立雄，夏明，陈超，刘超   

  1. 河南省食品药品评价中心，郑州河南450004
  • 收稿日期:2011-08-19 出版日期:2012-01-10 发布日期:2015-08-10
  • 作者简介:夏旭东，男，药师，硕士，药品安全性监测与评价。

Analysis of 412 ADR/ADE Cases of Asarone Injection

XIA Xu-dong, GONG Li-xiong, XIA Ming, CHEN Chao, LIU Chao   

  1. Henan Food and Drug Reevaluation Center, Henan Zhengzhou 450004, China
  • Received:2011-08-19 Online:2012-01-10 Published:2015-08-10

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摘要： 目的通过对412 例细辛脑注射液ADR/ADE 报告分析，探讨细辛脑注射液不良反应发生的一般规律及特点，为临床合理用药提供参考。方法采用回顾性研究方法，对河南省药品不良反应监测中心ADR 报告数据库中2006年~2010 年细辛脑注射液ADR/ADE 报告进行统计和分析。结果细辛脑注射液所致不良反应主要为皮肤及其附件损害184 例（26.44%），胃肠系统损害171 例（24.57%），全身性损害111 例（15.95%）。其中严重ADR/ADE 表现主要为呼吸困难、紫绀、过敏性休克、胸闷等。结论重视细辛脑注射液引发的不良反应，提高临床合理用药水平，完善药品说明书，防止严重不良反应发生，确保临床用药安全。

关键词: 细辛脑注射液, 不良反应, 过敏性休克, 分析

Abstract: Objective By analyzing 412 ADR/ADE reports of Asarone injection, the general laws and features of the reaction occurrences were discussed to provide reference for rational use of medicines in clinical trials. MethodsRelevant data was collected from database of Henan ADR Monitoring Center, statistical reviewed and analyzed,from 2006 to 2010. Results

Resultsshowed the main ADR/ADE damages were skin and its attachment, which counts 184 cases(26.44%), besides, 171 stomach and intestines cases(24.57%), 111 for systemic cases(15.95%). The common serious reactions were showed as dyspnea, cyanosis, anaphylactic shock and chest distress, etc. ConclusionThus, it is important to pay attention to the ADR/ADE caused by Asarone injections, in order to improve rational use of medicines in clinical, complete drug instructions, prevent serious adverse drug reactions taking place, ensuring clinical medication safety.

Key words: Asarone injection, adverse drug reaction, anaphylactic shock, analysis