注射用炎琥宁上市后安全性再评价研究

目的:对注射用炎琥宁临床应用的安全性进行综合评价。方法:以2009年10月1日-2010年9月30日10家二级以上医院应用重庆药友制药有限责任公司生产的注射用炎琥宁的住院患者为研究对象,观察记录患者的药品应用和不良反应/事件发生情况,使用开放式对照研究方法对数据进行统计分析。结果:观察用药患者4432例,发生一般不良反应/事件8例,发生率为0.18%。结论:注射用炎琥宁在监测医院内的不良反应/事件发生率较低、程度较轻。

Study on Post-marketing Safety Reevaluation of Potassium Sodium Dehydroandrographolide Succinate for Injection

OBJECTIVE： To evaluate the safety of Potassium sodium dehydroandrographolide succinate for injection（PSDSI）in the clinical application. METHODS： From Oct. 1, 2009 to Sept. 30, 2010, in 10 secondary and above hospitals, the hospitalized patients who used PSDSI of YaoPharma Co., Ltd. were regarded as the subject of study. Drug application and adverse reaction/ events were observed and recorded, and a open control research method was adopted for statistical data analysis. RESULTS： 4 432 patients were observed, with 8 cases of general adverse events and incidence rate of 0.18%. CONCLUSION： The incidence of adverse reaction/events of PSDSI is in a low rate and less degree in the involved hospitals.