治疗等价性和生物类似胰岛素和参考胰岛素之间的切换:随机对照试验的系统审查和元分析
Xiaoxuan Xing1, Lingyi Zhao1, Ke Wang1
1Department of Pharmacy, Xuanwu Hospital of Capital Medical University, Beijing, China.
Diabetes, obesity & metabolism
|November 28, 2025
概括
生物类似胰岛素在疗效,安全性和免疫性方面与参考胰岛素具有治疗等价性. 这支持它们的采用,以改善糖尿病治疗的获取和成本效益.
科学领域:
- 内分泌学 在内分泌学.
- 药理学 药理学是指药理学的学科.
- 糖尿病管理 糖尿病管理
背景情况:
- 生物类似胰岛素有可能提高糖尿病护理的准入率和成本效益.
- 在临床实践中,评估生物类似胰岛素和参考胰岛素之间的治疗等价性和切换动态至关重要.
研究的目的:
- 进行全面的元分析,评估与参考胰岛素相比,生物类似胰岛素的治疗等价性.
- 评估在生物类似和参考胰岛素配方之间切换的安全性,疗效和免疫性.
- 提供支持在糖尿病管理中采用生物类似胰岛素的证据.
主要方法:
- 在MEDLINE,Embase和Cochrane图书馆进行系统的文献搜索,截至2025年3月.
- 包括随机对照试验 (RCT) 评估治疗等价性和切换.
- 对包括HbA1c,血糖控制,不良事件和免疫性在内的结果的元分析,使用聚合平均差异和赔率比率.
主要成果:
- 分析了25个涉及10617名患者的RCT.
- 在生物类似胰岛素和参考胰岛素之间的疗效 (HbA1c变化,达到HbA1c<7.0%的比例) 或禁食血糖 (FBG) 没有统计学上显著的差异.
- 相当性和切换分析显示了可比的安全性和免疫性概况.
结论:
- 生物类似胰岛素在疗效,安全性和免疫性方面在治疗上相当于参考胰岛素.
- 这些发现支持将生物类似胰岛素纳入糖尿病治疗方案.
- 采用生物类似胰岛素可以提高患者获得治疗的机会,并提高成本效益.
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