二甲双胍格列吡嗪复方制剂对2型糖尿病患者B细胞功能的影响  

Glipizide-metformin compound improves B cell function in type 2 diabetic patients

作　　者：苏晓飞[1] 马建华[1] 孙睿[1] 郭琳[1] 付丽媛[1] 吴锦丹[1] 

机构地区：[1]南京医科大学附属南京第一医院内分泌科,南京210012

出　　处：《医学研究生学报》2010年第11期1160-1163,共4页Journal of Medical Postgraduates

基　　金：南京市医学科学发展项目(YKK0433)

摘　　要：目的二甲双胍、格列吡嗪是2种作用机制不同的降糖药。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,探讨二甲双胍格列吡嗪复方制剂与单药相比,其降糖、改善胰岛B细胞功能、减轻胰岛素抵抗作用。方法为多中心、随机、双盲、三模拟、阳性药平行对照临床试验,试验组(A组)21例,服用二甲双胍格列吡嗪复方制剂、格列吡嗪模拟片和二甲双胍模拟片;对照1组(B组)22例,服用二甲双胍片、格列吡嗪模拟片和二甲双胍格列吡嗪模拟片;对照2组(C组)22例,服用格列吡嗪片、二甲双胍模拟片和二甲双胍格列吡嗪模拟片,上述药物均为口服,1片/次,3次/d,疗程为12周。结果治疗后,A、C组空腹血糖(fasting blood glucose,FBG)、餐后2 h血糖(2 hourspostprandial bolld glucose,PBG2h)及3组糖化血红蛋白(glycosylated hemoglobin Alc,HbA1c)均较治疗前有明显下降(P<0.05);A、C组餐后2 h胰岛素(2 hours postprandial insulin level,PINS2 h)明显增加(P<0.05);与B组、C组相比,A组B细胞功能指数(homeostasis model assessment for beta cell function,Homa-B)明显增加(P<0.01);FBG、PBG2h、HbA1c、空腹胰岛素(fasting insulin,FINS)、PINS2h、胰岛素抵抗指数(homeostasis model assessment index of insulin resistance,Homa-IR)无明显变化(P>0.05)。安全性观察指标未见异常。结论二甲双胍格列吡嗪复方制剂与对照组相比,有效性和安全性相似;且与单药具有相似的降糖作用时,可明显改善胰岛B细胞功能。Objective Metformin and glipizide have different action mechanisms in reducing blood glucose.This study aimed to evaluate the efficacy and safety of the glipizide-metformin compound in the treatment of type 2 diabetes,and to compare the compound with either of the drugs used alone in their effects of decreasing blood glucose,improving Homa-B and reducing Homa-IR.Methods We conducted a multi-centered,double-blind,parallel-controlled randomized clinical trial,including 21 type-2 diabetic patients into Group A,treated with the glipizide-metformin compound,22 into Group B,given metformin alone,and another 22 into Group C,administered glipizide only,all at the same dose for 12 weeks.Then we compared the effect and safety of the glipizide-metformin compound,glipizide and metformin in the treatment of type 2 diabetes.Results After the treatment,there was a significant reduction in fasting blood glucose（FBG） and 2-hour postprandial blood glucose（PBG2h） in Groups A and C,as well as in glycosylated hemoglobin（HbA1c） in all the three groups（P0.05）.The level of 2-hour postprandial insulin（PINS2h） was significantly increased in both Groups A and C（P0.05）,and so was Homa-B in Group A（P0.01） as compared with B and C.No statistically significant differences were observed in FBG,PBG2h,HbA1c,FINS,PINS2h and Homa-IR after the treatment（P0.05）,nor in the rates of adverse effects among the three groups（P0.05）.Conclusion Compared with glipizide or metformin,the glipizide-metformin compound has similar effect and safety in lowering blood glucose,but can obviously improve Homa-B.

关 键 词：2型糖尿病 B细胞功能指数 二甲双胍 格列吡嗪 复方制剂 

分 类 号：R977.15[医药卫生—药品]