首页|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

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

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

insulin glarginegeneric drugtype 2 diabetes mellitusmeta-analysisefficacysafety

刘群、朱明亮、金秋阳、刘晓倩、耿燕楠、王莹、陈红、辛义周

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山东中医药大学附属医院药学部,济南 250011

甘精胰岛素 生物仿制药 2型糖尿病 Meta分析 疗效 安全性

山东省药品临床综合评价项目山东中医药学会临床药学科研专项山东省医学会临床药学科研专项

2022YZ003SDACM202204YXH2022ZX013

2024

中南药学
湖南省药学会

中南药学

CSTPCD
影响因子:0.736
ISSN:1672-2981
年,卷(期):2024.22(6)
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