412例细辛脑注射液ADR/ADE报告分析

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.

Analysis of 412 ADR/ADE Cases of Asarone Injection

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. Methods Relevant data was collected from database of Henan ADR Monitoring Center, statistical reviewed and analyzed, from 2006 to 2010. Results Results showed 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. Conclusion Thus, 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.