醒脑静注射液上市后安全性再评价研究  

Study on the post-marketing reassessment of Xingnaojing injection

作　　者：陈晓旭[1] 董改英[1] 

机构地区：[1]天津中医药大学第一附属医院,天津300193

出　　处：《天津中医药》2015年第5期312-313,共2页Tianjin Journal of Traditional Chinese Medicine

基　　金：天津市卫生局中医;中西医结合科研课题(07010)

摘　　要：[目的]综合评价醒脑静注射液上市后用药的安全性,对中药注射剂上市后安全性再评价进行综合研究。[方法]临床药师对本院针灸科使用醒脑静注射液的住院患者,从用药开始至用药结束15 d进行跟踪,填写评价筛选表,进行统计分析。[结果]共观察1 252例患者,未发生不良反应。[结论]在该研究中,醒脑静注射液未发生不良反应,临床应用相对安全。[Objective] To evaluate the safety of Xingnaojing injection as post-marketing drug, comprehensive study on safety evaluation of post-market traditional Chinese medicine injection. [Methods] Clinical pharmacists collect patients used Xingnaojing injection in acupuncture and moxibustion department of our hospital from beginning to end, totally 15 days of tracking, fill out the evaluation table,analyse the statistics. [Results] There were 1 252 patients in total, with no adverse reaction. [Conclusion] In this study, the effect of Xingnaojing injection has no adverse reaction, and the safety of clinical application is proved.

关 键 词：醒脑静注射液 上市后安全性再评价 不良反应 

分 类 号：R285.6[医药卫生—中药学]