目的 比較甘精胰島素注射液生物仿制藥與原研藥在治療2型糖尿病時的有效性與安全性。方法 采用回顧性隊列研究，收集2022年1月1日—2023年9月30日在山東中醫(yī)藥大學附屬醫(yī)院住院2次及以上且住院間隔大于3個月的應用甘精胰島素的2型糖尿病患者的相關臨床信息，采用傾向性評分匹配法（PSM），根據(jù)患者基線水平進行1∶1匹配。比較2組患者用藥至少3個月后的有效性及安全性。有效性研究指標為糖化血紅蛋白（HbAlc）的變化值，空腹血糖（FBG）的變化值及HbAlc＜7%的達標率。安全性指標為低血糖和皮疹瘙癢等發(fā)生率。結果 PSM前仿制藥組患者67例，原研藥組64例，2組年齡、糖尿病病程、合并使用非胰島素降糖藥物等方面有顯著差異（P＜0.05）。PSM后2組患者各42例，基線資料比較無明顯差異。經(jīng)統(tǒng)計分析，兩組患者HbAlc的降低值、FBG降低值及HbAlc＜7%的達標率方面無統(tǒng)計學差異，低血糖、皮疹瘙癢等的發(fā)生率，兩組差異也無統(tǒng)計學差異。結論 甘精胰島素生物仿制藥治療 2型糖尿病的有效性和安全性不劣于原研藥。

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

山東省藥品臨床綜合 評 價 項 目（ 2022YZ003 ）；齊 魯 衛(wèi) 生 與 健 康 領 軍 人 才 項 目（ 2019 ）；山 東 省 中 醫(yī) 藥 科 技 重 點項目（Z-2023052）；山東省醫(yī)學會臨床藥學科研專項（YXH2022ZX013）；山東省醫(yī)藥衛(wèi)生科技項目（ 202313010888 ）