比较草酸艾司西酞普兰片中标仿制药与原研药治疗抑郁障碍的有效性和安全性  

Comparison of Efficacy and Safety of Generic Escitalopram Oxalate Tablets and Original Escitalopram Oxalate Tablets in the Treatment of Depressive Disorder

作　　者：贾菲 鲍爽 刘珊珊[1,2] 牛梦溪[1,2] 臧彦楠 庄红艳 果伟[1,2] JIA Fei;BAO Shuang;LIU Shanshan;NIU Mengxi;ZANG Yannan;ZHUANG Hongyan;GUO Wei(Dept.of Pharmacy,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：《中国医院用药评价与分析》2023年第10期1174-1178,1184,共6页Evaluation and Analysis of Drug-use in Hospitals of China

基　　金：首都卫生发展科研专项资助项目(No.2020-1-2031)。

摘　　要：目的:比较草酸艾司西酞普兰片中标仿制药(百洛特)与原研药(来士普)治疗抑郁障碍的有效性和安全性,评价药品集中采购政策对医师处方行为及患者治疗费用的影响。方法:草酸艾司西酞普兰片是2019年3月23日起施行的第一批药品集中采购的药品。提取药品集中采购政策实施后6个月和上年同期我院使用草酸艾司西酞普兰片患者的门诊数据,根据所用药品厂家分为中标仿制药组和原研药组。对原研药和中标仿制药在临床使用中的用药剂量、血药浓度、常见不良反应指标异常发生率、换药率和药品费用进行比较。结果:中标仿制药组与原研药组患者血药浓度的差异无统计学意义(P>0.05);日剂量的差异虽有统计学意义(P<0.05),但无临床意义;肝肾功能异常、血脂异常和泌乳素升高等药品不良反应发生率的差异无统计学意义(P>0.05)。原研药组血糖升高患者所占比例(13.31%)低于中标仿制药组(18.17%),差异有统计学意义(P<0.05);试验时间段,原研药换为中标仿制药的换药率为5.45%,而参比时间段的换药率为2.23%,2个时间段上述换药者中分别约有0.86%和0.34%的患者又换回了原研药;试验时间段,患者次均中标仿制药品费用(638.06元)和总药品费用(1 331.78元)均明显低于参比时间段次均中标仿制药品费用(1 331.79元)和总药品费用(1 911.37元),仅为其62.97%和68.63%。结论:草酸艾司西酞普兰片中标仿制药与原研药的有效性和安全性相似,且中标仿制药经济学优势较大。OBJECTIVE:To compare the efficacy and safety of generic Escitalopram oxalate tablets(Bailuote)and original Escitalopram oxalate tablets(Lexapro)in the treatment of depressive disorder,an evaluate the effect of centralized drug procurement policy on clinicians’prescribing behavior and patients’treatment costs.METHODS:Escitalopram oxalate tablets were the first batch of drugs to be centrally purchased starting from Mar.23rd,2019.Outpatient data of patients with Escitalopram oxalate tablets 6 months after implementation of centralized drug procurement policy and the same period of last year in the hospital were extracted,and were divided into generic drug group and original drug group according to different drug manufacturers.The dosage,blood concentration,abnormal incidence of common adverse drug reactions,dressing change rate and drug cost of generic drug and original drug in clinical use were compared.RESULTS:There was no significant difference in blood drug concentration between the generic drug group and original drug group(P>0.05),although the difference in daily dose was statistically significant(P<0.05),but without clinical significance.and the difference in daily dose was not clinically significant.There was no significant difference in the incidence of adverse drug reactions such as abnormal liver and kidney function,dyslipidemia and prolactin elevation between the generic drug group and original drug group(P>0.05).The proportion of blood glucose increase in the generic drug group was 13.31%,lower than 18.17%in the original drug group,the difference was statistically significant(P<0.05).In the test period,the replace drug rate of original drug to the generic drug was 5.45%,and that of the reference period was 2.23%.In the two periods,about 0.86%and 0.34%of the patients changed to the generic drug,respectively.During the test period,the average cost of generic drugs(638.06 yuan)and total drug cost(1331.78 yuan)were significantly lower than that of generic drugs(1331.79 yuan)and total drug cost(1911.37 y

关 键 词：药品集中采购 艾司西酞普兰 有效性 安全性 真实世界研究 

分 类 号：R971.43[医药卫生—药品]