40例盐酸氨溴索注射剂致严重不良反应/事件分析

Analysis of 40 Cases of Adverse Drug Reactions/Event Induced by Ambroxol Hydrochloride Injection

目的探讨盐酸氨溴索注射剂致严重不良反应/事件(ADR/ADE)的一般规律、特点及影响因素,为临床用药提供参考。方法对我中心2011年收集到的40例由盐酸氨溴索注射剂引起的严重不良反应/事件报告进行统计、分析。结果患者集中分布在14岁以下和45岁以上,二者合计95%;严重不良反应表现主要为急性过敏样反应的症状;在30min内发生ADR的占总例数的92.5%。结论盐酸氨溴索注射剂致严重不良反应的发生与多种因素有关,对其引起的急性过敏样反应应高度重视,用药过程中必须严密监测。

Objective To probe into the status,characterstics and influencing factors of ADR/ADE cases induced by Ambroxol Hydrochloride injection. Methods We analyzed 40 ADR/ADE cases induced by ambroxol hydrochloride injection which were collected by Shandong ADR monitoring network from Jan. to Dec. of 2011. Results 95% of the patients were under 14 or more than 45 years old. The symptoms of serious ADR were mainly anaphylactoid reactions. 92.5% of ADR/ADE appeared within 30 min. Conclusion Serious ADR/ADE can be caused by a variety of factors. High attention should be paid to acute anaphylactoid reactions. Ambroxol hydrochloride injection should be used with more caution and exact monitoring.