仿制与原研舍曲林片疗效和安全性比较的真实世界研究  

Real world study on the comparison of efficacy and safety of the generic and original sertraline tablets

作　　者：果伟[1,2] 贾菲 刘珊珊 庄红艳[1,2] Guo Wei;Jia Fei;Liu Shanshan;Zhuang Hongyan(Department of Pharmacy,the National Clinical Research Center for Mental Disorders&Beijing Key Laboratory of Mental Disorders,Beijing Anding Hospital,Capital Medical University,Beijing 100088,China;Advanced Innovation Center for Human Brain Protection,Capital Medical University,Beijing 100069,China)

机构地区：[1]首都医科大学附属北京安定医院药事部,国家精神心理疾病临床医学研究中心,精神疾病诊断与治疗北京市重点实验室,北京100088 [2]人脑保护高精尖创新中心,首都医科大学,北京100069

出　　处：《药物不良反应杂志》2023年第3期159-164,共6页Adverse Drug Reactions Journal

基　　金：首都卫生发展科研专项(首发2018-4-2124, 首发2020-1-2031);北京市属医院科研培育计划(PX2019069, PZ2020031);北京药理学会科研扶持基金(20190107)。

摘　　要：目的比较国家组织集中带量采购中标药品舍曲林片仿制药(商品名:唯他停)与原研药(商品名:左洛复)治疗抑郁障碍的疗效和安全性, 为推动仿制药品合理使用提供依据。方法采用回顾性镜像比较的真实世界研究方法。收集药品集中采购政策实施后1年首都医科大学附属北京安定医院处方舍曲林片患者的门诊数据, 将患者分为仿制药组和原研药组, 经倾向性评分匹配后, 比较2组患者的处方日剂量、舍曲林血药浓度、实验室检查指标(催乳素、肝肾功能、血脂等)异常发生率。结果纳入本研究的抑郁障碍、广泛性焦虑障碍和强迫障碍患者共13 659例, 仿制药组5 973(43.73%)例, 男2 167例(36.28%), 女3 806例(63.72%);年龄(34±18)岁, 范围6~94岁;原研药组7 686(56.27%)例, 男2 709例(35.24%), 女4 977例(64.75%);年龄(35±19)岁, 范围6~95岁。仿制药组与原研药组舍曲林处方日剂量的差异有统计学意义[(161±47)mg比(166±44)mg, t=6.614, P<0.001], 仿制药组与原研药组舍曲林血药浓度的差异有统计学意义[(50±39)μg/L比(54±40)μg/L, t=2.616, P=0.009]。2组患者催乳素升高、肝肾功能异常发生率的差异均无统计学意义(均P>0.05);仿制药组与原研药组低于高密度脂蛋白胆固醇参考值下限者占比的差异有统计学意义[41.8%(734/1 758)比38.3%(673/1 758), χ2=4.409, P=0.039];高于低密度脂蛋白胆固醇参考值上限者占比的差异有统计学意义[41.8%(734/1 758)比45.4%(798/1 758), χ2=4.738, P=0.032]。结论本研究未发现舍曲林片仿制药与原研药在疗效和安全性方面存在有临床意义的差异。Objective To compare the efficacy and safety between the generic sertraline tablets,which was selected in the national centralized volume-based procurement of drugs(trade name:Weitating),and the original sertraline tablets(trade name:Levofloxacin)in the treatment for depressive disorder,and to provide a basis for promoting the rational use of the generic drugs.Methods Real world study using retrospective mirror-image comparison was adopted.The outpatient data of patients who were prescribed sertraline tablets one year after the implementation of the national centralized volume-based procurement policy in Beijing Anding Hospital,Capital Medical University were collected.The patients were divided into the generic drug group and the original drug group.After the propensity score matching,the daily dose of prescription,blood concentration of sertraline,and incidence of abnormal laboratory test items(prolactin,liver and kidney function,blood lipids,etc.)of patients in the 2 groups were analyzed.Results A total of 13659 patients with depression,generalized anxiety disorder,and obsessive-compulsive disorder were enrolled in the study,including 5973(43.73%)patients in the generic drug group and 7686(56.27%)patients in the original drug group.Among the 5973 patients in the generic drug group,2167(36.28%)were male and 3806(63.72%)were female,aged(34±18)years,ranging from 6 to 94 years.Among the 7686(56.27%)patients in the original drug group,2709(35.24%)were male and 4977(64.75%)were female,aged(35±19)years,ranging from 6 to 95 years.The difference between the daily dose of sertraline in prescription in the generic drug group and the original drug group was statistically significant[(161.00±46.58)mg vs.(166.34±43.67)mg,t=6.614,P<0.001].The difference of blood concentration of sertraline in patients between the generic drug group and the original drug group was statistically significant[(50.41±39.49)μg/L vs.(53.80±39.62)μg/L,t=2.616,P=0.009].The differences in incidence of prolactin elevation and liver and kidney dy

关 键 词：舍曲林 有效性研究 安全 带量采购 真实世界研究 

分 类 号：R969[医药卫生—药理学]