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2h血糖(P2hBG)、糖化血红蛋白(HbA1c)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%vs12%)。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。
Objective To evaluate the efficacy and safety of pioglitazone /mefformin hydrochloride in the treatment of type 2 diabetes mellitus patients. Methods A randomized, double-blind, metformin and pioglitazone hydrochloride-controlled, and muhicenter 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 glucose （FBG） , 2 h postprandial blood glucose （P2hBG） and HbAlc levels in tow groups were significantly reduced after 16-week treatment （ P 〈 0. 01 ）. In pioglitazone/metformin group, the mean reductions of FBG, P2hBG and HbAlc levels were （1.92±1.77）mmol·L^-1, （2.49 ±3.13）mmol·L^-1, （1.27 ±1.45 ） % respectively. In metformin and pioglitazone group, the mean reductions of FBG, P2hBG and HbA1c levels were （2.24 ±2. 11 ）mmol·L^-1, （2. 89 ±3. 71） mmol·L^-1,（1.49±1.52）% respectively. The differences in reductions of FBG, P2hBG and HbA1 c level between the groups were not statistically significant. The incidence of adverse drug reaction in two groups was similar （ 10% vs 12% ）. Conclusion This result provides an efficacy and safety of pioglitazone /metformin in the treatment of type 2 diabetes mellitus.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2009年第6期483-486,共4页
The Chinese Journal of Clinical Pharmacology
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
type 2 diabetes mellitus
pioglitazone/metformin
metform in hydrochloride
pioglitazone hydrochloride
作者简介
胡红琳（1971-），女，副主任医师主要从事糖尿病的临床与研究
通讯作者：王长江，主任医师，硕士生导师Tel：（0551）2923084 E-mail：ehjw82@126．com
