甘精胰岛素生物仿制药与原研药治疗2型糖尿病临床有效性及安全性的Meta分析  

Meta-analysis of clinical efficacy and safety of generic and original insulin glargine for type 2 diabetes mellitus

作　　者：刘群[1] 朱明亮 金秋阳 刘晓倩 耿燕楠[1] 王莹 陈红 辛义周[1] LIU Qun;ZHU Ming-liang;JIN Qiu-yang;LIU Xiao-qian;GENG Yan-nan;WANG Ying;CHEN Hong;XIN Yi-zhou(Department of Pharmacy,The Affiliated Hospital of Shandong University of Traditional Chinese Medicine,Jinan 250011)

机构地区：[1]山东中医药大学附属医院药学部,济南250011

出　　处：《中南药学》2024年第6期1668-1673,共6页Central South Pharmacy

基　　金：山东省药品临床综合评价项目(No.2022YZ003);山东中医药学会临床药学科研专项基金项目(No.SDACM202204);山东省医学会临床药学科研专项(No.YXH2022ZX013)。

摘　　要：目的系统性评价甘精胰岛素生物仿制药与原研药治疗2型糖尿病的临床有效性与安全性。方法检索国内外相关文献,系统分析甘精胰岛素生物仿制药与原研药治疗2型糖尿病人群的有效性和安全性的区别。结果Meta分析结果显示,甘精胰岛素生物仿制药与原研品种在降低空腹血糖、糖化血红蛋白(HbA1c)水平及HbA1c达标率方面差异无统计学意义;在低血糖发生率及总体不良事件报告率方面差异无统计学意义。结论本研究结果显示,从有效性和安全性方面考虑,甘精胰岛素生物仿制药与原研药并无明显差异。但因纳入文献质量和数量有限,仍需大样本、多中心的随机对照试验来进一步证实该结论。Objective To evaluate the clinical efficacy and safety of original and generic insulin glargine for type 2 diabetes mellitus(T2DM).Methods Domestic and foreign literatures were systematically reviewed.Meta-analysis was used for the evaluation the efficiency and safety.Results Meta-analysis showed that there was no significant difference in reducing fasting blood glucose,glycosylated hemoglobin(HbA1c)level and HbA1c compliance rate(P>0.05)between the generic and the original drug.There was no significant difference in the incidence of hypoglycemia and total adverse reactions between domestic and imported insulin glargine(P>0.05).Conclusion There is no significant difference between insulin glargine generic and original drugs in the efficacy and safety.However,limited by the quality and quantity of the included literatures,large sample and multi-center RCT are needed to further confirm this conclusion.

关 键 词：甘精胰岛素 生物仿制药 2型糖尿病 META分析 疗效 安全性 

分 类 号：R587.1[医药卫生—内分泌]