中国药物警戒 ›› 2016, Vol. 13 ›› Issue (10): 609-613.

• 安全性评价与合理用药 • 上一篇    下一篇

康艾注射液不良反应/事件报告分析

王力剑, 金锋, 樊若曦, 李雷, 关瑜, 曲毅, 朱旭*   

  1. 吉林省食品药品安全监测中心,吉林 长春130062
  • 收稿日期:2016-11-23 修回日期:2016-11-23 出版日期:2016-10-20 发布日期:2016-11-23
  • 通讯作者: 朱旭,男,本科,药师,上市后药械安全性监测。E-mail:7624349@qq.com
  • 作者简介:王力剑,男,硕士,副主任药师,上市后药械安全性监测。

Analysis of Adverse Drug Reactions/Events Caused by Kang’ai Injection

WANG Li-jian, JIN Feng, FAN Ruo-xi, LI Lei, GUAN Yu, QU Yi, ZHU Xu*   

  1. Jilin Safety Monitoring Center for Food and Drug, Jilin Changchun 130062, China
  • Received:2016-11-23 Revised:2016-11-23 Online:2016-10-20 Published:2016-11-23

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摘要： 目的 通过分析康艾注射液不良反应/事件的一般规律及特点,为临床安全合理用药提供参考。方法 采用回顾性研究方法,对我省食品药品安全监测中心报告数据库中1 906例康艾注射液不良反应/事件报告进行回顾性研究。结果 本组资料老年居多(51.73%),不良反应/事件以全身性损害为主(32.63%),表现为过敏性休克、呼吸困难、寒战和发热等,但说明书中无相关风险提示。结论 重视康艾注射液引发的不良反应/事件,完善药品说明书,提高临床合理用药水平。

关键词: 康艾注射液, 药品不良反应/事件, 分析

Abstract: Objective To study the general pattern and characteristics of adverse drug reactions/events(ADR/ADE) induced by Kang’ai injection, so as to provide references for improve rational use of medicines in clinic. Methods 1 906 reports of ADR/ADE related to the kang’ai injection in Jilin province were analyzed using retrospective study method. Results Among 1 906 reports, the elderly accountted for 51.73%. The main ADR/ADE was systemic damage(32.63%). The major clinical manifestations were anaphylactic shock, dyspnea, shiver and fever, etc, but there was no warning of these in the drug instructions. Conclusion It’s important to pay attention to the ADR/ADE caused by kang’ai injection, and perfect drug instructions, in order to improve rational use of medicines in clinic.

Key words: Kang’, ai injection, adverse drug reaction/ event, analysis

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