双黄连注射剂不良反应的原因及分析

目的观察、分析和总结双黄连注射剂的不良反应和应对措施。方法通过查阅1994～2008年期间国内公开发行的医药卫生期刊和国家食品药品监督管理局药品不良反应监测中心《信息通报》有关药品不良反应的资料进行分析。结果11083例双黄连注射剂不良反应的病例报告中出现严重不良反应的有306例,涉及158家企业的产品。性别、年龄段没有明显差异;以用药当天出现不良反应为主,严重不良反应的治愈或好转率〉90%,总死亡率高达5.9%,大多数病例对疾病本身影响不大。结论应根据双黄连注射液出现不良反应的可能原因,采取有针对性的安全防治措施。

Reaction and Analysis on ADR Caused by Shuanghuanglian Injection

Objective To observe, analyze and summary of ADR caused by Shuanghuanglian Injection and its response measures. Methods Through the inspection period from 1994 to 2008, ADRs information from domestic public offering of medical and health journals and ＂Information Communications ＂ publicized by State Food and Drug Administration Adverse Drug Reaction Monitoring Center were analyzed. Results In the 11,083 ADR cases, cases of serious adverse reactions were 306 cases, involving 158 enterprises products. Sex and age were no significant difference. ADR occurred mainly within the day. The cured or improved rate of serious ADR〉90%, with a total mortality rate as high as 5. 9%, the majority of cases have little effect on the disease itself. Conclusions According to the possible causes of ADR, the prevention and control measures targeted safety are adopted.