【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。更多还原

【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.更多还原