参芎葡萄糖注射液上市后安全性再评价

Safety Re-Evaluation of Salivae Miltiorrhizae,Liguspyragine Hydrichloride and Glucose Injection After Marketing

目的评价参芎葡萄糖注射液上市后的安全性,了解其临床用药特点及不良反应发生情况。方法采用嵌入式病例对照研究法,对2015年1月1日至2016年1月31日重庆市4家使用过参芎葡萄糖注射液(贵州景峰注射剂有限公司生产)的医院住院患者进行分析,使用开放式对照研究法进行统计和分析。结果观察用药患者共4 038例,其中一般不良反应/不良事件7例,发生率为1. 73‰。结论参芎葡萄糖注射液在监测医院内的不良反应/不良事件发生率属于"偶见"。

Objective To evaluate the safety of Salivae Miltiorrhizae,Liguspyragine Hydrichloride and Glucose Injection after marketing and to understand its clinical medication characteristics and adverse reactions. Methods The embedded case-control study was conducted to analyze the inpatients of four hospitals who used Salivae Miltiorrhizae,Liguspyragine Hydrichloride and Glucose Injection（ Guizhou Jingfeng Injection Co.,Ltd.） in Chongqing from January 1,2015 to January 31,2016. The data were statistically analyzed by open control study method. Results A total of 4 038 patients were observed,including 7 cases of general adverse reactions/adverse events,with an incidence rate of 1. 73 ‰. Conclusion The incidence of adverse reactions/adverse events in Salviae Miltiorrhizae,Liguspyragine Hydrochloride and Glucose Injection is occasionally.