艾塞那肽与沙格列汀联合二甲双胍治疗2型糖尿病患者的疗效与安全性比较  

Efficacy and safety of exenatide versus saxagliptin combined with metformin in patients with type 2 diabetes mellitus

作　　者：张先祥[1] 阳皓[1] 杨刚毅[2] 叶菲[2] 李伶[3] 李钶[2] 李彦[1] 罗涌[1] 

机构地区：[1]重庆三峡中心医院内分泌科,万州404000 [2]重庆医科大学附属第二医院内分泌科,重庆400010 [3]重庆医科大学检验系临床生化教研室,重庆400016

出　　处：《第三军医大学学报》2013年第14期1531-1534,共4页Journal of Third Military Medical University

基　　金：重庆市科委项目(CSTC2010AB5016);重庆市卫生局项目(2010-2-361);重庆市万州区科委项目(WZ0105007)~~

摘　　要：目的评估艾塞那肽与沙格列汀联合二甲双胍治疗2型糖尿病(type 2 diabetes mellitus,T2DM)患者的有效性与安全性。方法收集2011年1月到2012年12月于我院内分泌科门诊就诊的T2DM患者,按随机数字表法分为两组:艾塞那肽组37例(男性17例,女性20例),年龄(55.6±8.2)岁;沙格列汀组37例(男性15例,女性22例),年龄(57.6±8.6)岁。两组均联合二甲双胍治疗16周。主要疗效指标为治疗前后糖化血红蛋白(glycosylated hemoglobin,HbA1c)的变化,次要疗效指标包括受试者达到HbA1c<7.0%的人数百分比及空腹血糖(fasting plasma glucose,FPG)的降幅。结果治疗后艾塞那肽组T2DM患者HbA1c下降(0.75±0.69)%,沙格列汀组患者HbA1c下降(0.59±0.89)%;艾塞那肽组FPG下降幅度高于沙格列汀组[(1.79±1.29)mmol/L vs(1.54±1.75)mmol/L,P<0.05]。两组HbA1c的达标率(38.2%vs 37.0%)无显著性差异(P>0.05);艾塞那肽对控制体质量及收缩压的效果优于沙格列汀(P<0.05)。两组均无严重低血糖事件发生,报告不良事件的发生无统计学差异(P>0.05)。结论艾塞那肽与沙格列汀均能有效控制T2DM患者血糖水平,安全性好;艾塞那肽较沙格列汀有利于降低体质量和血压。Objective To compare the efficacy and safety between exenatide and saxagliptin when they are combined with metformin in treatment of type 2 diabetes mellitus. Methods A total of 74 type 2 dia- betic patients with poor glycemic control admitted in our department from January 2011 to December 2012 were randomly divided into 2 groups, the exenatide group（n =37, 17 males and 20 females, 55.6 ±8.2 years old） and the saxagliptin group（ n = 37,15 males and 22 females, 57.6 - 8.6 years old）. Both groups were combined with Mefformin therapy for 16 weeks. The main index of the effect was the change of glycosylated haemoglobin （HbAlc） before and after the treatment. The secondary indexes of the effect were the percentage of HbAlc （7.0%） and the decline of fasting blood glucose （FBG）. Results Exenatide resulted in HbAlc decreased by （0.75±0.69） % after the treatment, while saxagliptin caused a decrease by （0.59 ± 0.89 ） %. FBG levels were decreased significantly in exenatide group than the saxagliptin group （ 1.79±1.29 vs 1.54 ± 1.75 mmol/L, P 〈0.01 ）. However, there was no significant difference between the two groups in the control rate of HbAlc （ 38.2% vs 37.0%, P 〉 0. 05 ）. Furthermore, exenatide had significant effect on body weight and systolic blood pressure than saxagliptin （P 〈 0. 05）. The adverse events of the 2 groups were slight, and there was no hypo- glycemia found in 2 groups. Conclusion Both exenatide and saxagliptin effectively control blood glucose for type 2 diabetes mellitus, with sound safety. Exenatide may be more beneficial to the patients accompanied with obesity and hypertension than saxagliptin.

关 键 词：艾塞那肽 沙格列汀 二甲双胍 2型糖尿病 

分 类 号：R587.105[医药卫生—内分泌] R977.15[医药卫生—内科学]