参芪扶正注射液上市后安全性再评价研究

Study of post marketing safety reevaluation of Shenqi Fuzheng injection

为促进参芪扶正注射液(以下简称参芪扶正)的临床安全用药,该文对参芪扶正的上市后安全性研究进行了系统梳理。其中包括多中心、大样本、注册登记式的安全性监测研究、基于国家自发呈报系统(spontaneous reporting system,SRS)数据分析、基于全国20家三甲医院的医院信息系统(hospital information system,HIS)数据分析和国内外文献研究。该研究认为参芪扶正具有较好的安全性,其不良反应多为过敏反应,主要累及皮肤及其附件损害、全身性损害,严重者可出现过敏性休克。不良反应/事件(adverse drug reaction/event,ADR/E)多发于中老年人,可能与用药(肿瘤)人群有关。基于SRS数据的预警分析与文献研究均认为"静脉炎"的发生与参芪扶正用药有较强关联。

In order to promote the Shenqifuzheng injection（SQFZ） clinical medication safety,this study reevaluate on SQFZ post marketing safety study systematically.Including multi center large sample registration type safety monitoring research,the analysis based on national spontaneous reporting system data,the analysis based on the 20 national hospital information system data and literature research.Above the analysis,it suggests that SQFZ has good security.The more adverse drug reaction（ADR） as allergic reactions,mainly involved in the damage of skin,appendages and its systemic damage,serious person can appear allergic shock.ADR/E is more common in the elderly,may be related to medication（tumor） populations.Early warning analysis based on SRS data and literature research are of the view that ＂phlebitis＂ has a strong association with SQFZ used.