基于中文文献的盐酸二甲双胍仿制药一致性评价

目的:了解盐酸二甲双胍仿制药的一致性,以促进临床用药选择的有效与安全。方法:计算机检索CNKI与CBM数据库,纳入对比国产制剂与格华止的体外溶出试验、生物等效性试验和临床有效性与安全性的随机对照试验,按类型进行定性或定量分析。结果:分别纳入7、10、5篇研究。纳入评价的国产制剂与格华止的体外溶出度与溶出参数存在显著差异;部分生物等效性试验显示部分国产制剂与格华止不等效;格华止普通片在部分有效性指标上可能优于国产缓释片,在安全性方面可能优于国产普通片。结论:现有证据无法充分支持国产二甲双胍仿制药与原研药具有一致性,部分仿制药在药学特性、生物等效性和临床一致性方面与原研药相比可能有一定差距。

A consistency evaluation based on Chinese literatures for generic metformin hydrochloride

Objective:To understand consistency among generic metformin hydrochloride, and promote effectiveness and safety in clinical drug utilization.Methods: CNKI and CBM databases were electrically searched. Dissolution tests, bioequivalence studies and RCTs comparing domestic formulations and Glucophage were included. Qualitative or quantitative analysis was conducted.Results: 7, 10 and 5 researches were ifnally included respectively. The dissolution rates of included domestic formulations were signiifcantly different from Glucophage; some studies showed bioinequivalence results between domestic formulations and Glucophage. Clinical effectiveness was generally similar, while Glucophage uncoated tablets may be superior to domestic ones on some outcomes and safer than domestic ones. Conclusion: Consistency between generic and brand name formulations is not fully supported by current evidence. There are some potential gaps between some metformin hydrochloride formulations and Glucophage in the pharmaceutical, biological and clinical respects.