二甲双胍格列吡嗪复方制剂治疗2型糖尿病的随机双盲多中心临床研究  

A double-blind randomized multiple center clinical trial on observing the effect of fixed-dose glipizide/metformin on type 2 diabetes

作　　者：郑旭琴[1] 李红[2] 沈备[1] 王晓东[1] 谷卫[3] 匡洪宇[4] 李强[5] 刘超[1] 

机构地区：[1]南京医科大学第一附属医院内分泌科,江苏南京210029 [2]浙江大学医学院附属第一医院,浙江杭州310003 [3]浙江大学医学院附属第二医院,浙江杭州310006 [4]哈尔滨医科大学附属第一临床医学院,沈阳哈尔滨150001 [5]哈尔滨医科大学附属第二临床医学院,沈阳哈尔滨150086

出　　处：《实用临床医药杂志》2008年第8期3-7,共5页Journal of Clinical Medicine in Practice

摘　　要：目的通过临床观察评价二甲双胍格列吡嗪复方制剂治疗2型糖尿病的有效性和安全性。方法采取双盲双模拟、随机、阳性药平行对照、多中心临床研究方法,用药观察周期为12周。其中,试验组服用二甲双胍格列吡嗪片+模拟格列吡嗪片+模拟二甲双胍片;对照组服用模拟二甲双胍格列吡嗪片+格列吡嗪片+二甲双胍片。结果五个中心共入选224例患者,其中,试验组113例,对照组111例。经治疗12周后,试验组和对照组空腹血糖(FBG)、餐后两小时血糖(PBG 2 h)、糖化血红蛋白(HbA1c)都较用药前显著下降,但两组间比较无显著性差异。两组治疗12周后空腹胰岛素(I NS 0 h)都较治疗前明显下降,而餐后两小时胰岛素(I NS 2 h)均较治疗前明显升高,但两组间比较无统计学差异。试验组和对照组在治疗12周后总胆固醇(TC)和甘油三酯(TG)都较治疗前有所降低,但两组间比较也无显著性差异。试验组与对照组共发生不良事件51例,主要为低血糖、腹泻、尿路感染、转氨酶升高等。两组间不良事件发生率比较无统计学差异。结论对2型糖尿病患者而言,二甲双胍格列吡嗪是一种安全有效的降糖药物,便于临床推广使用。Objective To evaluate the effect and safety of fixed - dose glipizide/metformin tablets on type 2 diabetes. Methods This is 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 113 patients who received glipizide/metformin tablets and 111 taking glipizide co-ad- ministered with metformin on five centers. The patients in both groups got a significant reduction in fasting blood glucose （FBG）, 2 hours postprandial blood glucose （PBG 2 h） and glycosylated hemoglobin （HbAlc）values after 12-week therapy. There was a significant decrease of fasting in- sulin level, whereas 2 hours postprandial insulin level was increased. No statistical difference be- tween two groups was found. The rates of side effect in two groups showed no statistical differ- ence. Conclusions Fixed-dose glipizide/metformin is 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 复方制剂 

分 类 号：R587.1[医药卫生—内分泌]