中国药物警戒 ›› 2010, Vol. 7 ›› Issue (8): 500-503.

• 药品不良反应监测 • 上一篇    下一篇

161例细辛脑注射液新的严重的不良反应/事件分析

江腊梅   

  1. 济南市药品不良反应/医疗器械不良事件监测中心,山东 济南250001
  • 收稿日期:2010-06-04 修回日期:2016-02-22 出版日期:2010-08-08 发布日期:2016-02-22
  • 作者简介:江腊梅,女,本科,主任药师,药品不良反应监测。

Analysis on 161 New or Serious Reports of Xixinnao Injection

JIANG La-mei   

  1. Jinan Adverse Drug Reactions /Adverse Event Monitoring Centre, Shandong Jinan 250001
  • Received:2010-06-04 Revised:2016-02-22 Online:2010-08-08 Published:2016-02-22

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摘要： 目的 通过对近4年来细辛脑注射液致不良反应/事件（ADR/ADE）报告进行回顾性分析,为临床合理用药提供参考。方法 对济南市药品不良反应监测中心2006~2009年收到的161例细辛脑注射液新的、严重的ADR/ADE报告表进行统计分析。结果 细辛脑注射液致161例ADR/ADE病例,发生时间在用药20min以内的129例,占80.12%;儿童为高发人群,占49.69%。细辛脑注射液生产工艺中的辅料、药物本身的稳定性、临床联合及配伍用药等均是导致ADR/ADE的主要原因。结论 细辛脑注射液所致的临床ADR/ADE应引起临床高度重视;建议完善药品说明书。希望有关部门进一步研究该药品的安全性。

关键词: 细辛脑注射液, 不良反应/事件, 儿童, 增溶剂（吐温 80）

Abstract: Objective of the past 4 years Xixinnao injection adverse reaction/event(ADR/ADE) reports were reviewed, provide a reference for clinical medication. Methods Jinan ADR Monitoring Center received 161 cases 2006~2009 Xixinnao injection of new, serious(the new strict) of ADR/ADE reports were collected and analyzed. Results Xixinnao injection of 161 patients with new stringent ADR/ADE cases occurred within 20min of time in 129 drug cases, accounting for 80.12%; children as high risk group, accounting for 49.69% in all cases. Xixinnao injection production process of accessories, the stability of the drug itself, and the combination of clinical medicine such as the joint leading to ADR/ADE of the main reasons. Conclusion Xixinnao injection in clinical ADR/ADE should attract great attention of clinical medicine; proposed system for pharmacy instructions. Hope that the security departments of the drugs should be further studied.

Key words: Xixinnao injection, adverse reaction/event, children, Solubilizer(Tween 80)

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