二甲双胍分别联用艾塞那肽与甘精胰岛素的疗效及安全性比较  

Efficacy and safety comparison on the respective combination of metformin with exenatide and insulin glargine

作　　者：邱春娟[1] 曹怡[1] 陈彬[1] 焦秀敏[1] 

机构地区：[1]北京军区总医院内分泌科,北京100700

出　　处：《中国卫生检验杂志》2015年第17期2913-2916,共4页Chinese Journal of Health Laboratory Technology

摘　　要：目的比较二甲双胍分别联用艾塞那肽与甘精胰岛素的有效性和安全性。方法纳入80例单用二甲双胍后血糖控制不佳的2型糖尿病患者,随机分配到联用艾塞那肽组或甘精胰岛素组治疗,艾塞那肽起始5μg每日2次皮下注射,4周后加至10μg每日2次皮下注射;甘精胰岛素起始剂量为0.1 U/kg^0.2 U/kg,每周根据随访前连续3 d早餐前血糖调整剂量。分别于基线、第26周检测Hb A1c、血糖、体重、血压和血脂等指标。结果 26周后,艾塞那肽治疗组Hb A1c的均值及Hb A1c<7%的达标率与甘精胰岛素组相当,差异无统计学意义(P>0.05),但艾塞那肽组复合终点(Hb A1c<7%且无低血糖发生及无体重增加)达标率更高。甘精胰岛素组FPG均值低于艾塞那肽组,艾塞那肽组2 h PG均值低于甘精胰岛素组,差异有统计学意义(P<0.05)。艾塞那肽组体重、腰围、体重指数、收缩压、甘油三酯分别较基线下降,差异有统计学意义(P<0.01),甘精胰岛素组体重、腰围、体重指数较基线增加,差异有统计学意义(P<0.05);2组均无严重不良反应。结论二甲双胍联用艾塞那肽与联用甘精胰岛素降糖疗效相当,且具有减轻体重、降低收缩压、改善血脂等降糖外优势,安全性及耐受性良好。Objective To compare the efficacy and safety of respective combination of metformin with exenatide and insulin glargine. Methods 80 T2 DM patients who had inadequate glycaemic control on metformin were randomly assigned to the exenatide（ EXEN） group or the insulin glargine（ IGLA） group. EXEN group started at a dose of 5 μg subcutaneous injection twice per day,and then changed to 10 μg subcutaneous injection after 4 weeks twice per day. IGLA group started at a dose of0. 1 U / kg- 0. 2 U / kg,and adjusted it according to the peripheral blood glucose level before breakfast on the continuous 3 days.At the baseline,and 26 weeks after treatment,to measure the indexes like Hb A1 c,glucose,weight,blood pressure and lipid.Results 26 weeks later,the mean Hb A1 c and the qualified rate of Hb A1 c 7% in the EXEN group were similar to that in the IGLA group,and the difference was not statistically significant（ P〈0. 05）,while the percentage of subjects reaching the composite endpoint of Hb A1 c 7% with no hypoglycemia and no weight gain was significantly higher in the EXEN group,and the differences were statistically significant（ P〈0. 05）; the mean FPG was lower than that in EXEN group,at 2 h the mean PG in EXEN group was lower than that in the IGLA group,and the differences were statistically significant（ P〈0. 05）. And the body weight,waist circumference,body mass index,systolic pressure and triglyceride significantly decreased in the EXEN group,compared with the baseline,and the differences were statistically significant（ P〈0. 05）. And the body weight,waist circumference,body mass index increased in the IGLA group,compared with the baseline. There was no serious adverse occurrence in the two groups. Conclusion The combination of metformine with exenatide and insulin glargine showed a similar efficacy with the hypoglycemic advantage of reducing weight,systolic blood pressure（ SDB） and improving blood lipid. What is more,exenatide had good safety and tolerability.

关 键 词：2型糖尿病 艾塞那肽 甘精胰岛素 

分 类 号：R587.1[医药卫生—内分泌]