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
刘群 1朱明亮 1金秋阳 1刘晓倩 1耿燕楠 1王莹 1陈红 1辛义周1
作者信息
- 1. 山东中医药大学附属医院药学部,济南 250011
- 折叠
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.
Abstract
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Key words
insulin glargine/generic drug/type 2 diabetes mellitus/meta-analysis/efficacy/safety引用本文复制引用
基金项目
山东省药品临床综合评价项目(2022YZ003)
山东中医药学会临床药学科研专项(SDACM202204)
山东省医学会临床药学科研专项(YXH2022ZX013)
出版年
2024
NETL
NSTL
万方数据