2012年5月—2015年5月天津海滨人民医院醒脑静注射液的上市后安全性再评价

Post-marketing safety reassessment of Xingnaojing Injection in Tianjin Coastal People's Hospital from May 2012 to May 2015

目的评价醒脑静注射液上市后临床应用中的安全性,以期为规范临床合理用药提供参考依据。方法对天津海滨人民医院2012年5月—2015年5月使用醒脑静注射液的712例住院患者进行观察,填写醒脑静注射液上市后安全再评价筛选卡,对停药后患者进行15 d以上随访。采用Excel软件进行数据处理。结果 712例住院患者均未出现不良反应。结论无锡济民可信山禾药业股份有限公司生产的醒脑静注射液不良反应发生率低,在天津海滨人民医院的临床应用相对安全。

Objective To evaluate post-marketing safety reassessment of Xingnaojing Injection in the clinical use, and to provide reference for rational drug use in the clinic. Methods Inpatients（712 cases） using Xingnaojing Injection in Tianjin Coastal People＇s Hospital from May 2012 to May 2015 were observed. Post-marketing safety reassessment screening card of Xingnaojing Injection were filled. The patients were followed up for 15 more days after drug withdrawal. Excel software was used for data processing. Results There were no adverse reaction in 712 cases of inpatients. Conclusion The incidence of adverse reaction of Xingnaojing Injection produced by Wuxi Jimin Kexin Shanhe Pharmaceutical Co., Ltd is low, and its clinical application is relatively safe in Tianjin Coastal People＇s Hospital.