中国药业2023，Vol.32Issue(24)：50-54,5.DOI:10.3969/j.issn.1006-4931.2023.24.012
格列美脲集采中选仿制药与原研药临床效果的真实世界研究
Clinical Effects of Bid-Winning Generic Glimepiride in the Centralized Volume-Based Procurement and Original-Patented Drugs:A Real-World Study
摘要
Abstract
Objective To evaluate the difference in clinical effects between the bid-winning generic glimepiride in the centralized volume-based procurement and original-patented drugs in the treatment of diabetes mellitus type 2(T2DM)based on the real world data.Methods The data of outpatients with T2DM treated with original-patented glimepiride(from January 1,2019 to December 30,2019)and bid-winning generic glimepiride(from October 1,2020 to September 30,2021)in the the electronic medical record system of Xuanwu Hospital,Capital Medical University were extracted.The patients were divided into the original-patented group and generic group according to different medications.The direct indicators(efficacy and safety)and indirect indicators(compliance and economy)of treatment effects between the two groups were compared after the patients' baseline data were corrected by the propensity score matching(PSM)method.Results A total of 81 pairs of patients were successfully matched for direct indicator analysis.The reduction of glycosylated hemoglobin(HbA1C)and fasting blood glucose(FBG)after treatment in the two groups was similar(P>0.05),while the HbA1C standard-reaching rate in the generic group(<7.0%)was significantly higher than that in the original-patented group(P<0.05);the incidence of transaminases(alanine aminotransferase,aspartate aminotransferase)and serum creatinine abnormalities after treatment in the two groups was similar(P>0.05).A total of 1 350 pairs of patients were successfully matched for indirect indicator analysis.Compared with those in the original-patented group,the dose and defined daily doses in the generic group both increased by 20.34%,and the defined daily cost decreased by 98.20%;the continuous drug-treatment rates for six and nine months in the generic group were significantly lower than those in the original-patented group(P<0.05),the incidence of dose up-regulation from 4 mg to 6 mg and overall dose up-regulation rate were significantly higher than those in the original-patented group(P<0.05).Conclusion The efficacy and safety of the bid-winning generic glimepiride in the centralized volume-based procurement are not inferior to those of the original-patented drug,and the former has a lower cost.关键词
格列美脲/药品集采/仿制药/原研药/真实世界研究/有效性/安全性Key words
glimepiride/centralized volume-based procurement/generic drug/original-patented drug/real world study/efficacy/safety分类
医药卫生引用本文复制引用
罗巧,王之舟,刘文娜,崔晓辉,董宪喆,张兰..格列美脲集采中选仿制药与原研药临床效果的真实世界研究[J].中国药业,2023,32(24):50-54,5.基金项目
中国科学技术协会2022年度科技智库青年人才计划项目[20220615ZZ07110070] （）
北京市医院管理中心"登峰"人才培养计划[DFL20190803] （）
首都科技创新领军人才培养工程[Z191100006119017]. （）
