阿卡波糖仿制药与原研药治疗2型糖尿病的临床综合评价  

Clinical Evaluation of Generic Acarbose and Original Drug in the Treatment of Type 2 Diabetes Mellitus

作　　者：洪小媛 潘芸芸 陈吉生[1] HONG Xiaoyuan;PAN Yunyun;CHEN Jisheng(The First Affiliated Hospital of Guangdong Pharmaceutical University,Guangzhou,Guangdong 510000,China)

机构地区：[1]广东药科大学附属第一医院,广东广州510000

出　　处：《今日药学》2020年第10期715-720,共6页Pharmacy Today

基　　金：国家自然科学基金资助项目(81603526);广州市科技计划项目(201803010096)。

摘　　要：目的系统评价阿卡波糖仿制药与原研药治疗2型糖尿病的临床综合价值,为临床治疗选择提供循证参考。方法计算机检索Pub Med、EMBase、Cochrane、CBM、CJFD、VIP和万方数据库。对符合纳入标准的RCT进行资料提取和质量评价后,运用Rev Man 5.3软件进行Meta分析。收集医药公司的药检报告、医院上报的不良反应和医院的销售情况,对比分析仿制与原研阿卡波糖的疗效、不良反应、质量及患者的可及性等。结果Meta分析结果显示,阿卡波糖仿制药的疗效与原研药无差异,但不良反应发生率较低。随着国家集采项目推进,成本-效果比上将会趋同。结合真实世界信息,仿制药与原研药的质量指标、患者可获得性及可支付性无明显差异。结论阿卡波糖仿制药的疗效、药品质量及可及性与原研药相当,经济性将会趋同。两者都可作为2型糖尿病患者长期控制血糖的用药选择。OBJECTIVE To systematically evaluate the clinical value of generic Acarbose and original drug in the treatment of type 2 diabetes,and to provide evidence-based reference for clinical treatment.METHODS Retrieval from Pub Med,EMBase,Cochrane library,CBM,CJFD,VIP and Wanfang Database.After quality evaluation and information extraction of RCT which met inclusion criteria,Rev Man 5.3 statistical software were used for Meta-analysis.To collect the acarbose test reports and,sales status from pharmaceutical companiesthe adverse reactions reports from hospitals,then compared and analyzed the quality,efficacy,adverse reactions and accessibility of patients between generic drugs and original drugs.RESULTS Results of Meta-analysis showed there were no significance between the efficacy of generic drugs and original drugs,while the incidence of adverse reactions of generic drugs was significantly lower.As the promotion of national centralized procurement projects,the ratio of cost and effectiveness would be identical.Refer to the reality information,there were no significant differences in quality,patient availability and affordability between the generic and the original drug.CONCLUSION Therapeutic efficacy,quality accessibility and affordability of generic acarbose are similar to those of original drug,the economy will be identical.The generic drug and the original drug can be used as the long-term blood glucose control drug choice for type 2 diabetes patients.

关 键 词：2型糖尿病 阿卡波糖 仿制药 临床综合评价 

分 类 号：R969[医药卫生—药理学]