目的 評價醒腦靜注射液上市后臨床應用中的安全性,以期為規(guī)范臨床合理用藥提供參考依據(jù)。方法 對天津海濱人民醫(yī)院2012年5月—2015年5月使用醒腦靜注射液的712例住院患者進行觀察,填寫醒腦靜注射液上市后安全再評價篩選卡,對停藥后患者進行15 d以上隨訪。采用Excel軟件進行數(shù)據(jù)處理。結果 712例住院患者均未出現(xiàn)不良反應。結論 無錫濟民可信山禾藥業(yè)股份有限公司生產(chǎn)的醒腦靜注射液不良反應發(fā)生率低,在天津海濱人民醫(yī)院的臨床應用相對安全。

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.