【摘要】 目的 比较集中带量采购（简称“集采”）沙格列汀仿制药和原研药治疗2型糖尿病的有效性与安全性。方法 纳入2021年9月至2023年8月使用沙格列汀治疗2型糖尿病的患者共342例，根据使用的沙格列汀种类分为原研药组（n=164）和仿制药组（n=178）。采用倾向性评分匹配法（PSM）平衡2组基线特征。比较2组用药6个月后的有效性与安全性。有效性的主要研究指标为糖化血红蛋白（HbA1c）变化值，次要研究指标为空腹血糖（FBG）变化值和HbA1c达标（HbA1c<7.0%）率。安全性的研究指标为低血糖事件和肝肾功能异常。结果 PSM后，2组各匹配到141例患者。2组HbA1c变化值、FBG变化值与HbA1c达标率比较，差异均无统计学意义（P > 0.05）。2组低血糖事件和肝肾功能异常的发生率比较，差异均无统计学意义（P > 0.05）。2组持续治疗和换药情况比较，差异无统计学意义（P > 0.05）。结论 集采沙格列汀仿制药治疗2型糖尿病的有效性和安全性不劣于原研药，可作为临床治疗2型糖尿病的一种选择。更多还原

【Abstract】 AIM To compare the efficacy and safety between centralized volume-based procurement of a certain generic version of saxagliptin and the original drug in the treatment of type 2 diabetes mellitus（T2 DM）. METHODS A total of 342 patients with T2 DM who were treated with saxagliptin at 2 centers from September 2021 to August 2023 were included and divided into the generic group（n=164） and original saxagliptin group（n=178）. Propensity score matching（PSM） was used to balance the baseline characteristics between the 2 groups. The efficacy and safety of the 2 groups were compared after at least 6 months of treatment. Efficacy was evaluated through changes in glycated hemoglobin（HbA1c）, changes in fasting blood glucose（FBG）, and the rate of achieving HbA1c < 7.0%. For safety, hypoglycemic events and abnormalities in liver and kidney function were assessed. RESULTS After PSM, 141 patients were matched in each group. There were no statistically significant differences between 2 groups in the variation of HbA1c（%）, the variation in FBG(mmol·L^-1) and the achievement rate of HbA1c < 7.0%（P > 0.05）. There were also no statistically significant differences in the incidence of hypoglycemic events, liver function abnormalities, and kidney function abnormalities between 2 groups（P > 0.05）. There were no significant differences in continuous treatment and medication change between the 2 groups.CONCLUSION The efficacy and safety of a certain generic version of saxagliptin procured through centralized volumebased procurement in the treatment of patients with T2 DM were noninferior to the original saxagliptin.更多还原