我院参麦注射液上市后安全性再评价的研究

Study on the post-marketing reassessment of Shenmai injection in our hospital

目的:综合评价参麦注射液上市后用药的安全性,探索中药注射剂上市后安全性再评价的方法和模式。方法:对本院2009年6月—2010年1月使用参麦注射液(正大青春宝)的住院患者,从用药开始至用药结束15 d进行全程跟踪,填写评价筛选表,发生不良反应患者纳入为病例组,进行统计分析。结果:共观察371例患者,发生不良反应共2例,均以果糖注射剂作为溶媒,不良反应表现为皮疹。结论:参麦注射液不良反应的发生率较低,临床使用中药注射液欠规范,应加强管理。

Objective： To evaluate the post-marketing safety of the Shenmai injection and discuss the method of the post-marketing safety of the TCM injection. Method： To choose the patient using the Shenmai injection（made in Chiatai Qingchungbao Pharmaceutical Co Ltd） from June 2009 to January 2010,the clinical pharmacist evaluate the whole range of using the Shenmai injection and fill in the Screening schedule. Result： It was observed the 371 patients and 2 cases of adverse drug reaction（skin rash） using the fructose as the solvent was discovered. Conclusion ： The probability of adverse drug reaction occurred is low.Rational use of the TCM injection should be enhanced.