盐酸二甲双胍肠溶胶囊治疗2型糖尿病有效性与安全性的研究  

Study on the efficacy and safety of Metformin hydrochloride enteric-coated capsules in patients with type 2 diabetes mellituss

作　　者：伍一鸣[1] 张健[1] 顾楠[1] 董其娟 刘瑞云 张虹 刘海霞[5] 赵永才[6] 程霖[7] 朴莲善[8] 边芳 何刚 李全民 杜玮[12] 王昭玲[13] 徐伟 钟历勇[15] 郭晓蕙[1] WU Yiming;ZHANG Jian;GU Nan(Department of Endocrinology,Peking University First Hospital,Beijing 100034,China)

机构地区：[1]北京大学第一医院内分泌科,100034 [2]郑州人民医院内分泌科 [3]保定市第一中医医院内分泌科 [4]华北石油管理局总医院内分泌科 [5]潍坊市人民医院内分泌科 [6]沧州市中心医院内分泌科 [7]菏泽市立医院内分泌科 [8]延边大学附属医院内分泌科 [9]沧州市人民医院内分泌科 [10]菏泽市中医医院内分泌科 [11]中国人民解放军火箭军总医院内分泌科 [12]新乡医学院第三附属医院内分泌科 [13]徐州市第一人民医院内分泌科 [14]徐州市中心医院内分泌科 [15]首都医科大学附属北京天坛医院内分泌科

出　　处：《中国糖尿病杂志》2025年第3期210-214,共5页Chinese Journal of Diabetes

摘　　要：目的 评价生活方式干预血糖控制不佳的T2DM患者使用盐酸二甲双胍肠溶胶囊(君力达^(®))治疗的有效性和安全性。方法 本研究采用多中心、随机、双盲、阳性药平行对照的非劣效性试验设计,选取2020年7月至2022年3月15家研究中心招募的T2DM患者419例,随机分为口服君力达^(®)的观察组(Obs,n=209)和盐酸二甲双胍片(格华止^(®))对照(Con,n=210)组,4周内增至最佳有效剂量2 g/d并维持合理剂量至观察24周结束。比较治疗后两组全分析集(FAS)、符合方案集(PPS)Hb A_(1)c及其达标率、FPG、体重,评估安全集(SS)安全性和不良事件(AE)。结果 最终入组414例,FAS为414例(Obs组207例、Con组207例),PPS为328例(Obs组164例、Con组164例),SS为414例(Obs组207例、Con组207例)。两组FAS、PPS治疗后Hb A_(1)c、FPG、体重均低于治疗前(P<0.05)。两组FAS、PPS的Hb A_(1)c达标率比较,差异无统计学意义(P>0.05)。两组非劣效检验结果显示,FAS(-0.154,95%CI-0.384~0.069)、PPS(-0.139,95%CI-0.390~0.112)CI下限>-0.4%,Obs组达到非劣效终点。两组Hb A1c达标率、依从性、安全性指标及AE发生率比较,差异无统计学意义(P>0.05)。结论 君力达?在控制血糖方面非劣效于格华止?,治疗T2DM安全、有效。Objective To evaluate the efficacy and safety of enteric-coated metformin hydrochloride capsules(Junlida^(®))in patients with T2DM and poor glycemic control under lifestyle interventions.Methods In this study,419 patients with T2DM were recruited from 15 research centers from July 2020 to March 2022,and randomly divided into observation(Obs)group(n=209)and control group(Con,n=210)using a multicenter,randomized,double-blind,non-inferiority trial design.Patients in the Obs group were treated with enteric-coated Metformin hydrochloride capsules(Junlida^(®)),and patients in the Con group were treated with Metformin hydrochloride tablets(Glucophage^(®)).The optimal effective dose of 2 g/d was achieved within 4 weeks,and the reasonable dose was maintained until the end of treatment.The treatment period was 24 weeks.HbAic and its compliance rate,FPG,and body weight were compared between the two groups in full analysis set(FAS)and protocol set(PPS).Safety and adverse events(AE)were evaluated in safety set(SS).Results A total of 414 participants were randomized(207 cases in Obs group and 207 cases in Con group).414 cases in FAS population(207 cases in Obs group and 207 cases in Con group),and 328 cases in PPS population(164 cases in Obs group and 164 cases in Con group),and 414 cases in SS population(207 cases in Obs group and 207 cases in Con group).After treatment,HbAic,FPG and body weight were lower in both groups(P<0.05)in FAS and PPS.HbAic compliance rate was not significantly different between the two groups in FAS and PPS(P>0.05).The results of non-inferiority test showed that the lower limit was>-0.4%in both FAS(-0.154,95%CI-0.384~0.069)and PPS(-0.139,95%CI-0.390~0.112),and the Obs group reached non-inferiority end point.The achievement rate,compliance rate,safety index and incidence of AE were not significantly different between the two groups(P>0.05).Conclusions Junlida^(®)demonstrated non-inferiority to Glucophage^(®)in glycemic control and can be safely and effectively used in patients with diabetes.

关 键 词：糖尿病 2型 盐酸二甲双胍 非劣效性试验 

分 类 号：R587.1[医药卫生—内分泌]