基于医院药物警戒系统的丹红注射液安全性再评价  

Safety Reevaluation of Danhong Injections Based on Hospital Pharmacovigilance System and Nested Case Control Study

作　　者：葛莉莉[1] 沈颖[1] 刘瑕瑜 薛莉丽 何小燕 袁秀研 戴婷[1] GE Lili;SHEN Ying;LIU Xiayu;XUE Lili;HE Xiaoyan;YUAN Xiuyan;Dai Ting(Department of Pharmacy,Yixing People's Hospital,Yixing 214200,China)

机构地区：[1]江苏省宜兴市人民医院药学部,宜兴214200

出　　处：《药学与临床研究》2022年第4期368-370,共3页Pharmaceutical and Clinical Research

基　　金：2018无锡市科技局医疗卫生指导性项目(第6-2批35号)。

摘　　要：目的:利用医院药物警戒系统对本院丹红注射液安全性进行再评价。方法:运用医院药物警戒系统中不良反应(ADR)主动监测功能,收集丹红注射液不良反应病例组资料,并从HIS系统中提取同期使用丹红注射液患者资料,通过巢式病例对照研究,匹配对照组,对两组资料进行分析。结果:在4163例使用丹红注射液的患者中,有15例出现ADR,发生率为3.6‰。经分析,病例组入院病情严重、溶媒为木糖醇以及合并二丁酰环磷腺苷钙的病例显著多于对照组。将上述3项因素进行多因素Logistal回归分析,发现溶媒使用木糖醇是丹红注射液发生ADR的危险因素。结论:丹红注射液不良反应发生率较低,溶媒使用木糖醇是其发生ADR的危险因素,利用医院药物警戒系统进行药物安全性评价方法适宜,值得推广。Objective:To reevaluate the safety of Danhong injections by the hospital pharmacovigilance system.Methods:The adverse drug reaction(ADR)active monitoring function in the hospital pharmacovigilance system was used to collect data of the ADR case group of Danhong injections,the data of patients who used Danhong injections at the same time were extracted from the HIS system to form the control group by matching through a nested case-control study,and the data of the two groups were analyzed.Results:Among the 4163 patients who used Danhong injections,15 had adverse reactions,the incidence was 3.6‰.The results showed that there were significant differences between the two groups in the severity at admission,the use of xylitol as vehicles and the combination of calcium dibutyryladenosine cyclophosphate.Multivariate analysis demonstrated that xylitol was the risk factor of ADR in Danhong injections.Conclusions:The incidence of adverse reactions of Danhong injections was low.The method of drug safety evaluation using hospital pharmacovigilance system is reliable and worthy of popularization.

关 键 词：丹红注射液 医院药物警戒系统 巢式病例对照 安全性再评价 

分 类 号：R969.3[医药卫生—药理学]