36例患者应用双黄连注射液安全性分析

36 ADR CSSO reports of shuanghuanglian injection

目的了解双黄连注射液临床应用的安全性,探讨其不良反应发生规律,为临床使用提供参考。方法通过检索国家药品不良反应监测中心数据库,对安徽省2008年1月1日～2008年12月31日使用双黄连注射液出现不良反应的患者情况进行分类统计。结果双黄连注射液不良反应主要表现为全身性损害、呼吸系统损害及多器官多系统损害,程度轻重不一,预后大多良好,但严重的也可引起死亡。结论药品生产企业应加强上市后的安全性监测,并开展生产工艺和质量研究,完善药品说明书;医生、患者应严格按照药品说明书的规定合理用药,以减少药品不良反应的发生;药品监管部门应加强对双黄连注射液的再评价工作。

Aim To explore the clinical safty of shuanghuanglian injection,and to explore its rule of ADR so as to provide reference for clinical use.Method The ADR of Shuanghuanglian injection were collected and analyzed from January 1,2008 to December 31,2008 by consulting the national ADR database.Result The ADR of shuanghuanglian injection and mainly resulted in systemic,respiratory,multi-organ or multi-system damage.Most of them have good prognosis.Yet some may cause death.Conclusion Manufacturers should regula the process, perfect the directions the doctors and patents should strictly obey the directions in order to deduce the ADR. Drug reg- ulators should strengthen the evaluation of Shuanghuanglian injection.