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吡格列酮二甲双胍片治疗2型糖尿病的多中心随机双盲平行对照临床试验
引用本文:胡红琳,王长江,张木勋,阎胜利,刘俊江,朱旅云,何勇,高雅. 吡格列酮二甲双胍片治疗2型糖尿病的多中心随机双盲平行对照临床试验[J]. 中国临床药理学杂志, 2009, 25(6)
作者姓名:胡红琳  王长江  张木勋  阎胜利  刘俊江  朱旅云  何勇  高雅
作者单位:1. 安徽医科大学第一附属医院内分泌科,合肥,230022
2. 华中科技大学同济医院内分泌科,武汉,250001
3. 青岛大学附属医院内分泌科,青岛,266001
4. 河北省人民医院内分泌科,石家庄,050000
5. 中国人民解放军白求恩国际和平医院内分泌科,石家庄,050000
摘    要:目的 以盐酸二甲双胍和盐酸吡格列酮(均降糖药)为对照,评价吡格列酮二甲双胍片治疗2型糖尿病的疗效和安全性.方法 用多中心随机双盲双模拟阳性平行对照的试验设计,观察240例2型糖尿病病人,分为吡格列酮二甲双胍片组(试验组)和盐酸二甲双胍、盐酸吡格列酮组(对照组).结果 用药16周后,与基础值相比,试验组空腹血糖(FBG)、餐后2 h血糖(P2hBG)、糖化血红蛋白(HbAlC)分别下降(1.92±1.77)mmol·L~(-1),(2.49±3.13)mmol·L~(-1),(1.27±1.45)%;对照组,FBG、PBG、HbA1c分别下降(2.24±2.11)mmol·L~(-1),(2.89±3.71)mmol·L~(-1),(1.49±1.52)%,2组下降各指标治疗前后比较均有显著性差异;但2组间比较无显著性差异.2组不良反应发生率比较无统计学差异(10% vs 12%).结论 吡格列酮二甲双胍片是治疗2型糖尿病有效和安全的药物.

关 键 词:2型糖尿病  吡格列酮二甲双胍片  盐酸吡格列酮  盐酸二甲双胍

Randomized,double-blind,double-dummy,controlled clinical trial of pioglitazone/metformin in the treatment of type 2 diabetes
HU Hong-lin,WANG Chang-jiang,ZHANG Mu-xun,YAN Sheng-li,LIU Jun-jiang,ZHU Lv-yun,HE Yong,GAO Ya. Randomized,double-blind,double-dummy,controlled clinical trial of pioglitazone/metformin in the treatment of type 2 diabetes[J]. The Chinese Journal of Clinical Pharmacology, 2009, 25(6)
Authors:HU Hong-lin  WANG Chang-jiang  ZHANG Mu-xun  YAN Sheng-li  LIU Jun-jiang  ZHU Lv-yun  HE Yong  GAO Ya
Affiliation:HU Hong-lin1,WANG Chang-jiang1,ZHANG Mu-xun2,YAN Sheng-li3,LIU Jun-jiang4,ZHU Lv-yun5,HE Yong1,GAO Ya1(1.Department of Endocrinology,The First Affiliated Hospital of Anhui Medical University,Hefei 230022,China,2.Department of Endocrinology,Tongji Hospital,Huazhong University of Science and Technology,Wuhan 250001,3.Department of Endocrinology,The Affiliated Hospital of Qingdao University,Qingdao 266001,4.Department of Endocrinology,Hebei Provincal Hospital,Shijiazhuang 050000,5.Department ...
Abstract:Objective To evaluate the efficacy and safety of pioglitazone /metformin hydrochloride in the treatment of type 2 diabetes mellitus patients.Methods A randomized,double-blind,metformin and pioglitazone hydrochloride-controlled,and multicenter clinical trial was conducted.A total of 240 patients with type 2 diabetes mellitus were enrolled in this study,in which 120 patients received pioglitazone/metformin,and 120 patients received metformin and pioglitazone.Result Comparing to the baseline,the fasting blood ...
Keywords:type 2 diabetes mellitus  pioglitazone /metformin  metform in hydrochloride  pioglitazone hydrochloride  
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