摘要
目的对参芪扶正注射液上市后临床应用的安全性进行临床研究和综合评价。方法对438例用参芪扶正注射液的住院患者进行观察,记录患者的药品使用和不良反应发生情况,并进行数据统计分析。结果观察病例438份,参芪扶正注射液使用的适应证、用法用量基本符合说明书的规定,不良反应发生率为0.23%。结论我院参芪扶正注射液临床使用较为规范,参芪扶正注射液发生不良反应的概率较小,临床使用相对安全。
Objective To assess the clinical use and occurrence of ad- verse reactions of Shenqifuzheng injection, and to provide reference for rational drug use in the clinic. Methods Based on the method of the real world study, the clinical data of Shenqifuzheng hos- pital was tracked and analyzed. Results A total of 438 inpatients were enrolled in this study. Shenqifuzheng injection was used accorded with the drug instruction mostly. The incidence of adverse drug reaction （ADR） of Shenqifuzheng injection was 0.23%, which showed good safety. Conclusion The application of Shenqifuzheng injection was rational and safe in our hospital. The real world study is effective for clinical reasearch of medicine.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2015年第18期1881-1882,共2页
The Chinese Journal of Clinical Pharmacology
基金
重大新药创制科技重大专项基金资助项目(2009ZX09502-030)
湖北省重点实验室开放基金资助项目(02.03.2014-06)
关键词
参芪扶正注射液
医院集中监测
安全性再评价
临床应用
不良反应
Shenqifuzheng injection
hospital centralized monitoring
safety reassessment
clinical use
adverse drug reaction
