阿卡波糖仿制药和原研药疗效、安全性及成本的Meta分析  

Efficacy,Safety and Cost of the Generic and Original Preparation of Acarbose: A Meta-analysis

作　　者：纪永军[1] 王红梅[1] 刘利珍[1] 朱宏伟 赵志刚[2] JI Yong-jun;WANG Hong-mei;LIU Li-zhen;ZHU Hong-wei;ZHAO Zhi-gang(Department of Pharmacy,Yanqing District Hospital (Yanqing Hospital of Peking University Third Hospital),Beijing 102100,China;Department of Pharmacy,Beijing Tiantan Hospital Affiliated to Capital Medical University,Beijing 100050,China)

机构地区：[1]北京市延庆区医院(北京大学第三医院延庆医院)药剂科,北京102100 [2]首都医科大学附属北京天坛医院药学部,北京100050

出　　处：《药品评价》2018年第4期9-15,共7页Drug Evaluation

基　　金：2014年首都卫生发展科研专项项目;"北京基层医疗机构中成药利用评价及用药合理性监测研究"编号:首发2014-3-2043

摘　　要：目的:通过Meta分析比较阿卡波糖仿制药和原研药的疗效、安全性及成本,为临床选择提供循证参考。方法:计算机检索Pubmed、Cochrane、CNKI、万方、维普数据库,纳入比较阿卡波糖仿制药和原研药疗效、安全性及成本的随机对照试验。由两位研究员根据纳入和排除标准独立进行文献筛选、资料提取并评价质量后,采用Rev Man 5.3统计软件进行Meta分析。结果:纳入25项研究,共2089例患者,与原研药相比,仿制药阿卡波糖在降低空腹血糖[SMD=-0.09,95%CI(-0.03,0.20),P=0.13]、餐后血糖[SMD=0.11,95%CI(-0.01,0.23),P=0.07]、糖化血红蛋白[SMD=0.05,95%CI(-0.08,0.17),P=0.45]、体质指数[SMD=-0.03,95%CI(-0.20,0.14),P=0.75]、改善餐后胰岛素[SMD=1.14,95%CI(-0.01,2.28),P=0.05]及血糖控制有效率[OR=1.10,95%CI(0.75,1.60),P=0.63]等方面的差异均无统计学意义;原研药阿卡波糖在改善空腹胰岛素[SMD=0.23,95%CI(0.06,0.41),P=0.01]方面优于仿制药,而不良反应发生率[OR=0.71,95%CI(0.54,0.92),P=0.01]、治疗成本[MSD=-9.11,95%CI(-14.16,-4.07),P<0.001]却明显比仿制药阿卡波糖高。结论:阿卡波糖仿制药和原研药均能有效控制糖尿病患者的血糖,但安全性及成本有明显差异。Objective:To systematically review the efficacy,safety and cost of the generic and original preparation of acarbose,and provide evidencebased reference for clinical treatment.Methods:Retrieved from PubMed,Cochrane Library,CNKI,Wanfang Database,and VIP,related randomized controlled trials(RCT)about the efficacy,safety and cost of generic preparation of acarbose versus original preparation of acarbose were collected.Meta-analysis was performed using Rev Man5.3software after data extract and quality evaluation by two researchers.Results:25RCTs were included,involving2089patients.Compared with generic preparation of acarbose,there was no significant differences in reducing fasting bloodglucose(FBG)[SMD=-0.09,95%CI(-0.03,0.20),P=0.13],2-hour postprandial glucose(2hPG)[SMD=0.11,95%CI(-0.01,0.23),P=0.07],Glycosylated Hemoglobin(HbA1c)[SMD=0.05,95%CI(-0.08,0.17),P=0.45],Body Mass Index(BMI)[SMD=-0.03,95%CI(-0.20,0.14),P=0.75],and2-hour postprandial insulin(2hPI)[SMD=1.14,95%CI(-0.01,2.28),P=0.05].However,the fasting blood insulin(FBI)of original preparation of acarbose was significantly superior to generic preparation[SMD=0.23,95%CI(0.06,0.41),P=0.01],while the incidence of adverse drug reaction(ADR)and the cost in generic preparation group were significantly lower when compared with the original preparation of acarbose([OR=0.71,95%CI(0.54,0.92),P=0.01],[MSD=-9.11,95%CI(-14.16,-4.07),P<0.001],respectively).Conclusion:Both the generic and original preparation of acarbose can effectively reduce blood glucose levels,while there were significant differences in safety and cost.

关 键 词：阿卡波糖 仿制药 原研药 拜唐苹 META分析 

分 类 号：R977.15[医药卫生—药品]