144例双黄连注射剂不良反应/事件报告分析

目的 探讨双黄连注射剂不良反应/事件发生的一般规律和特点.方法 采用回顾性研究方法,对我市药品不良反应监测中心2005-2012年收集的144例双黄连注射剂不良反应/事件自发报告进行分析.结果 144例报告给药途径均为静脉滴注;14岁以下儿童患者74例,占报告总数的51.39％;不良反应以皮肤及其附件损害为主,主要表现为皮疹、荨麻疹等;临床存在不合理用药情况.结论 临床应严格按照药品说明书用药,并加强不良反应监测,以减少药品不良反应的发生.

Analysis of 144 cases of adverse drug reactions/events caused by Shuanghuanglian injection

Objective To explore the general characteristics of the adverse drug reactions/events （ADR/ ADE） caused by Shuanghuanglian injection （SHLI）. Methods By retrospective study methods, we analyzed the 144 spontaneous reports of SHLI ADR/ADE collected by Center for ADR monitoring of Guangzhou from 2005 to 2012. Results Intravenous drip was the administration way of 144 SHLI ADR./ ADE cases.Among 144 reports, children under 14 years old accounted for 51.39% （74/144）.The main ADR/ADE exhibited the skin and its accessories damage and the major clinical manifestations included rash, urticaria, etc.Clinical irrational drug use situation existed. Conclusion SHLI should be used strictly in accordance with the drug instructions and clinical ADR monitoring should be strengthened to decrease the incidence rate of ADR.