米格列奈对比阿卡波糖治疗2型糖尿病有效性和安全性的多中心、开放、随机对照临床研究  

Efficacy and safety of Mitiglinide versus Acarbosein treatment of patients with type 2 diabetes mellitus:An open,multi-center,randomized study

作　　者：袁扬[1] 梁军[2] 刘艳梅 马绍刚[4] 吴晨光 华飞[6] 王师远 司冬芹 李政 李庆 徐志刚 陆扬[1] 单英 唐瑛[6] 蒋淼 刘沛[7] 孙子林[1] 

机构地区：[1]东南大学附属中大医院内分泌科糖尿病研究所,南京210009 [2]江苏省徐州市中心医院内分泌科 [3]江苏省盐城市第一人民医院内分泌科 [4]江苏省淮安市第二人民医院内分泌科 [5]江苏省镇江市第一人民医院内分泌科 [6]江苏省常州市第一人民医院内分泌科 [7]东南大学公共卫生学院流行病学与卫生统计学系 [8]正大天晴药业集团股份有限公司医学部

出　　处：《中国糖尿病杂志》2018年第3期221-226,共6页Chinese Journal of Diabetes

摘　　要：目的比较阿卡波糖和米格列奈治疗T2DM的有效性和安全性。方法在该项多中心、开放、随机对照研究中,T2DM病程5年以下的患者被随机分为米格列奈组或阿卡波糖组,分别接受米格列奈钙片治疗10mg/次或阿卡波糖片治疗50 mg/次,3次/d,疗程均为12周。观察12周后HbA_1c、FBG、餐后血糖(PBG)的变化,以及安全性。结果本研究共入组患者248例,可进行疗效评价分析237例,其中米格列奈组118例,阿卡波糖组119例。治疗后,两组HbA_1c、FBG、PBG水平与基线比较均降低(P<0.0001)。12周时,HbA_1c治疗前后下降值,米格列奈组(1.27±1.04)%,阿卡波糖组(1.00±1.30)%,两组差值(0.27±1.19)%,两组比较差异有统计学意义(P>0.05)。治疗8周,米格列奈组FBG下降(1.31±1.29)mmol/L,阿卡波糖组(0.86±1.68)mmol/L,两组差值(0.45±1.51)mmol/L,两组比较,差异有统计学意义(P<0.05)。治疗12周,FBG和PBG下降值两组相当(P>0.05)。阿卡波糖组不良事件发生率为14.66%,米格列奈组为6.54%(P=0.0508);阿卡波糖组腹胀发生率高于米格列奈组(P=0.0055)。结论米格列奈和阿卡波糖均有降低HbA_1c、FBG及PBG的作用,且疗效相当,米格列奈较阿卡波糖有较少的胃肠道反应。Objective To evaluate the efficacy and safety of Mitiglinide versus Acarbose in patients with type 2 diabetes mellitus（T2DM）. Methods this open,multi-center,randomized controlled trial,patients diagnosed with T2DM within 5 years were randomly divided into two groups：Mitiglinide and Acarbose treatment group,and treated with Mitiglinide calcium tablets 10 mg or Acarbose tablets 50 mg three times a day for 12 weeks,respectively.Safety andthe changesof glycosylated hemoglobin（HbA_1c）,fasting blood glucose（FBG）,postprandial blood glucose（PBG）were compared after 12 weeks＇ follow up.Results A total of 248 patients were enrolled in this study and 237 patients could be incorporatedinto the evaluation analysis（118 in the mitiglinide group and 119 in the acarbose group）.After treatment,HbA_1c,FBG,and PBG were all decreased significantly in the two groups（all P〈0.0001）.HbA_1c reduction at week 12 was（1.27±1.04）%in the Mitiglinide group and（1.00±1.30）% in the Acarbose group.But there was no significant difference between two groups（0.27±1.19）%,P〈0.05）.At week 8,the FBG reduction was（1.31±1.29）mmol/L in Mitiglinide group and（0.86±1.68）mmol/L in Acarbose group.There was significant difference between the two groups[（0.45±1.51）mmol/L,P〈0.05].At week 12,the differences in FBG and PBG reduction were not significantly different between the two groups（P〈0.05）.The incidence of adverse event was14.66%in Mitiglinide group and 6.54%in Acarbose group（P=0.0508）.The incidence of abdominal distension was significantly higher in Acarbose group than in mitiglinide group（P =0.0055）. Conclusion The efficacy of Mitiglinide and Acarbose in lowering HbA_1c,FBG and PBG were similar.But the incidence of gastrointestinal side effect was lower in Mitiglinide group than in Acarbose group.

关 键 词：糖尿病 2型 米格列奈 阿卡波糖 有效性 安全性 

分 类 号：R587.1[医药卫生—内分泌]