帕罗西汀与艾司西酞普兰原研药和仿制药的疗效、安全性与经济性比较  

Comparison of Efficacy,Safety,and Economy of Paroxetine and Escitalopram Between Original-Patented Drugs and Generic Drugs

作　　者：刘文娜 董宪喆[2] 崔晓辉 李晓玲[2] 张兰[2] LIU Wenna;DONG Xianzhe;CUI Xiaohui;LI Xiaoling;ZHANG Lan(School of Pharmaceutical Sciences,Capital Medical University,Beijing,China 100069;Xuanwu Hospital,Capital Medical University·National Clinical Research Center for Geriatric Diseases,Beijing,China 100053)

机构地区：[1]首都医科大学药学院,北京100069 [2]首都医科大学宣武医院·国家老年疾病临床医学研究中心,北京100053

出　　处：《中国药业》2023年第8期104-108,共5页China Pharmaceuticals

基　　金：国家科技重大专项项目[2017ZX09101001-002-044];中国科学技术协会科技智库青年人才计划项目[20220615ZZ07110070];首都科技领军人才培养工程项目[Z191100006119017];北京市医院管理中心“登峰”人才培养计划项目[DFL20190803];首都医科大学宣武医院“汇智”人才工程学者计划项目[宣医院字[2018]53号]。

摘　　要：目的比较帕罗西汀和艾司西酞普兰仿制药与原研药在疗效、安全性、经济性方面的差异。方法回顾性分析国家组织药品集中带量采购政策实施后1年(2019年3月23日至2020年3月22日)医院门诊使用盐酸帕罗西汀片(仿制药乐友和原研药赛乐特)、草酸艾司西酞普兰片(仿制药百洛特和原研药来士普)患者的处方数据,按1∶1最邻近匹配法匹配后分析药物持有率(MPR,反映用药依从性),持续单药治疗率,药物持续治疗(3,6,9个月)率,剂量异常上调率及药物更换(含一次更换与二次更换)情况,比较两药的仿制药与原研药的人均年费用及年均费用占比。结果帕罗西汀,乐友组持续治疗6,9个月患者比例与持续单药治疗率明显高于赛乐特组(P<0.05),两组MPR≥0.8患者比例无明显差异(P>0.05);乐友组的二次换药率明显高于赛乐特组(P<0.05),乐友组的日均费用、人均年费用和年均费用占比均明显低于赛乐特组(P<0.05);艾司西酞普兰,百洛特组MPR≥0.8患者比例明显高于来士普组(P<0.05),持续单药治疗率和持续治疗3,6,9个月患者比例均明显低于来士普组(P<0.05);百洛特组的一次换药率明显低于来士普组(P<0.05),人均年费用和年均费用占比均明显低于来士普组(P<0.05),日均费用仅为来士普组的37.19%。结论帕罗西汀仿制药和原研药的疗效、安全性及患者用药依从性基本一致;艾司西酞普兰仿制药的患者用药依从性更好,但原研药的持续治疗率明显高于仿制药。两种仿制药的经济性均强于原研药。Objective To compare the efficacy,safety,and economy of paroxetine and escitalopram between original-patented drugs and generic drugs.Methods A retrospective analysis was conducted on the prescription data of outpatients who used Paroxetine Hydrochloride Tablets(generic drug Leyou and original-patented drug Seroxat)and Escitalopram Oxalate Tablets(generic drug Bailuote and original-patented drug Lexapro)in hospitals one year after the implementation of the National Centralized Drug Procurement(NCDP)policy.According to the 1∶1 nearest-neighbor propensity score matching method,the medication possession ratio(MPR,reflecting medication compliance),the continuous single drug treatment rate,the continuous treatment rate(for 3,6 and 9 months),the abnormal upregulation rate of continuous treatment dose,and the drug replacement situation(including the one-time and twice-times replacement)were analyzed.In addition,the per capita annual cost and annual cost ratio of generic drugs and original-patented drugs were compared.Results Paroxetine:the proportion of patients with continuous treatment for 6 and 9 months and the continuous single drug treatment rate in the Leyou group were higher than those in the Seroxat group(P<0.05),and there was no significant difference in the proportion of patients with MPR≥0.8 between the two groups(P>0.05);the twice-times replacement rate of drugs in the Leyou group was significantly higher than that in the Seroxat group(P<0.05),while the proportion of the average daily cost,per capita annual cost,and average annual cost in the Leyou group was significantly lower than that in the Seroxat group(P<0.05).Execitalopram:the proportion of patients with MPR≥0.8 in the Bailuote group was significantly higher than that in the Lexapro group(P<0.05),while the continuous single drug treatment rate and the proportion of patients with continuous treatment for 3,6,and 9 months in the Bailuote group were significantly lower than those in the Lexapro group(P<0.05);the one-time replacement rate of drugs i

关 键 词：国家组织药品集中带量采购 选择性5-羟色胺再摄取抑制剂 帕罗西汀 艾司西酞普兰 原研药 仿制药 疗效 安全性 经济性 

分 类 号：R969.3[医药卫生—药理学] R971[医药卫生—药学]