二甲双胍格列吡嗪片治疗2型糖尿病的有效性及安全性的临床研究  

Clinical study on efficacy and security of fixed-dose glipizide/metformin on type 2 diabetes mellitus(DM)

作　　者：姚璐[1] 吕肖锋[1] 纪欣[1] 张建立 

机构地区：[1]北京军区总医院内分泌科,北京100070 [2]北京四环科宝有限公司,北京100203

出　　处：《中国临床药理学与治疗学》2010年第7期803-808,共6页Chinese Journal of Clinical Pharmacology and Therapeutics

摘　　要：目的:以格列吡嗪片和二甲双胍片为对照,评价二甲双胍格列吡嗪片治疗2型糖尿病的有效性和安全性。方法:采用多中心、随机、双盲、三模拟、阳性药平行对照研究方法,用药观察周期为12周,其中试验组服用药物为二甲双胍格列吡嗪片+格列吡嗪模拟片+盐酸二甲双胍模拟片;格列吡嗪对照组服用药物为格列吡嗪片+二甲双胍格列吡嗪模拟片+盐酸二甲双胍片模拟片;盐酸二甲双胍对照组服用药物为盐酸二甲双胍片+格列吡嗪模拟片+二甲双胍格列吡嗪模拟片。结果:随机化入组患者352例,其中二甲双胍格列吡嗪组116例、二甲双胍组118例、格列吡嗪组118例。经治疗12周后,二甲双胍格列吡嗪片组、二甲双胍片组、格列吡嗪片组糖化血红蛋白(HbA1c)分别为(5.5±1.3)%、(6.0±1.4)%、(6.1±1.5)%;空腹血糖分别为(7.3±1.8)、(7.9±2.3)、(8.2±2.4)mmol/L;餐后2小时血糖分别为(11.0±4.0)、(12.2±4.2)、(12.5±4.5)mmol/L,3项指标较用药前均有显著下降,各组疗后组间比较差异有统计学意义(P<0.05)。治疗后3组餐后2小时胰岛素均有所上升,空腹胰岛素无明显变化。二甲双胍格列吡嗪片、二甲双胍片两组甘油三酯有所下降,格列吡嗪片组有所升高,胆固醇前后差值组间比较无统计学意义。三组共发生不良事件54例,不良反应22例,三组比较无统计学差异。结论:二甲双胍格列吡嗪片是一种安全有效的降糖药物。AIM：To evaluate the effect and safety of fixed-dose glipizide/metformintablets on type 2 diabetes. METHODS： This was a double blind randomized 12-week clinical observation on multiple centers comparing the blood glucose lowering effect and safety between fixed-dose glipizide/metformin tablets and glipizide co-administered with metformin. RESULTS：The cohort consisted of 116 patients who received glipizide/metformin tablets and 118 taking glipizide and 118 taking metformin. The levels of glycosylated hemoglobin （HbA1c）were （5.5±1.3）%,（6.0±1.4）% and （6.1±1.5）%,the levels of fasting blood glucose （FBG） were （7.3±1.8）,（7.9±2.3） and （8.2±2.4）mmol/L and the levels of 2 hours postprandial blood glucose （PBG 2 h） were （11.0±4.0）,（12.2±4.2） and （12.5±4.5）mmol/L, in glipizide/metformin group, metformin group, glipizide group, after 12-week therapy. The level of 2 hours postprandial insulin was increased,but the fasting insulin level was significantly changed. The levels of TG were decreased in glipizide/metformin and metformin groups,and that in the glipizide group was increased . There were no statistical difference of the rates of side effect in three groups.CONCLUSION： Fixed-dose glipizide/metformin is a convenient, effective and safe blood glucose lowering drug for diabetic patients.

关 键 词：2型糖尿病 二甲双胍 格列吡嗪 

分 类 号：R587[医药卫生—内分泌]