目的 比较甘精胰岛素注射液生物仿制药与原研药在治疗2型糖尿病时的有效性与安全性。方法 采用回顾性队列研究，收集2022年1月1日—2023年9月30日在山东中医药大学附属医院住院2次及以上且住院间隔大于3个月的应用甘精胰岛素的2型糖尿病患者的相关临床信息，采用倾向性评分匹配法（PSM），根据患者基线水平进行1∶1匹配。比较2组患者用药至少3个月后的有效性及安全性。有效性研究指标为糖化血红蛋白（HbAlc）的变化值，空腹血糖（FBG）的变化值及HbAlc＜7%的达标率。安全性指标为低血糖和皮疹瘙痒等发生率。结果 PSM前仿制药组患者67例，原研药组64例，2组年龄、糖尿病病程、合并使用非胰岛素降糖药物等方面有显著差异（P＜0.05）。PSM后2组患者各42例，基线资料比较无明显差异。经统计分析，两组患者HbAlc的降低值、FBG降低值及HbAlc＜7%的达标率方面无统计学差异，低血糖、皮疹瘙痒等的发生率，两组差异也无统计学差异。结论 甘精胰岛素生物仿制药治疗 2型糖尿病的有效性和安全性不劣于原研药。

Objective To compare the efficacy and safety between generic and original insulin glargine in treatment of type 2 diabetes. Methods Retrospective cohort study was used to collect the information of type 2 diabetes patients who used insulin glargine and were hospitalized twice or more from January 1st, 2022 to September 30th, 2023. The propensity score matching (PSM) was used to balance the baseline levels of covariates between the generic and original insulin glargine groups. The efficacy and safety of two groups were compared after at least three months. The primary outcome was the change of HbAlc from the baseline, and the secondary outcome was the change of fasting blood glucose (FBG) from baseline and the standard-reaching rate of HbAlc <7.0%. Safety was assessed based on adverse events that included hypoglycemia, and rash. Results Before PSM, there were significant differences between the two groups in age, duration of diabetes, combination use of other antidiabetic agents (P <0.05). After PSM, there were not statistically significant between two groups at baseline.The differences between the original group and the generic group in the reduction of HbA1c, the reduction of FBG and the standard-reaching rate of HbAlc 7.0% were not statistically significant. There was also no statistically significant difference in the incidence of hypoglycemia and rash between the two groups. Conclusion The efficacy and safety of generic insulin glargine in the treatment of type 2 diabetes are not inferior to the original drug.

R977

山东省药品临床综合 评 价 项 目（ 2022YZ003 ）；齐 鲁 卫 生 与 健 康 领 军 人 才 项 目（ 2019 ）；山 东 省 中 医 药 科 技 重 点项目（Z-2023052）；山东省医学会临床药学科研专项（YXH2022ZX013）；山东省医药卫生科技项目（ 202313010888 ）