基于倾向性评分匹配法评价格列美脲仿制药和原研药的疗效与安全性

Comparison of efficacy and safety of generic and original glimepiride by propensity score matching

目的比较格列美脲仿制药与原研药在治疗2型糖尿病时的疗效与安全性。方法收集于2020年1月1日-2021年12月31日期间在3家中心就诊的2型糖尿病并使用格列美脲患者(342例)的相关临床信息,采用倾向性评分匹配法(PSM)平衡2组患者基线水平。比较2组患者用药至少6个月后有效性与安全性。有效性主要研究指标为糖化血红蛋白(HbA1c)的变化值,有效性次要研究指标为空腹血糖(FBG)的变化值及HbA1c<7.0%的达标率。安全性指标为低血糖事件和肝肾功能异常。结果倾向性评分匹配后,原研药组和仿制药组分别纳入103例患者,2组患者基线在性别、年龄、体质量指数(BMI)、血糖水平及糖尿病病程等方面差异均无统计学意义(P>0.05)。HbA1c的降低值、FBG的降低值与HbA1c<7.0%的达标率方面,2组差异均无统计学意义(P>0.05)。低血糖事件的发生率、肝酶水平升高的比例与估算肾小球滤过率(eGFR)下降的比例方面,2组差异均无统计学意义(P>0.05)。结论格列美脲仿制药治疗2型糖尿病的有效性和安全性不劣于原研药。

AIM To compare the efficacy and safety between generic and original glimepiride in the treatment of type 2 diabetes.METHODS From January 1,2020 to December 31,2021,electronic medical records of 342 patients diagnosed as type 2 diabetes and treated with glimepiride in 3 centers were collected.The propensity score matching(PSM)was used to balance the baseline levels of covariates between the generic and original glimepiride groups.The efficacy and safety of 2 glimepiride groups were compared after more than 6 months of treatment.The primary outcome was the change of glycated hemoglobin A1c(HbA1c)from baseline,and the secondary outcome was the change of fasting blood glucose(FBG)from baseline and the standard-reaching rate of HbA1c<7.0%.Safety was assessed based on adverse events that included hypoglycemia,and abnormal liver and kidney function.RESULTS A total of 103 pairs patients completed propensity score matching.and the differences in gender,age,body mass index(BMI),plasma glucose level,and duration of diabetes between 2 groups at baseline were not statistically significant(P>0.05).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 HbA1c<7.0%were not statistically significant(P>0.05).The differences in the incidence of hypoglycemia events,the proportion of increased liver enzyme levels and the proportion of decreased estimated glomerular filtration rate(eGFR)between the original group and the generic group were not statistically significant(P>0.05).CONCLUSION The efficacy and safety of generic glimepiride in the treatment of patients with type 2 diabetes are noninferiority to the original glimepiride.