利拉鲁肽与西格列汀对胰岛素控制欠佳的肥胖伴2型糖尿病患者的疗效和安全性比较  

Efficacy and safety of liraglutide versus sitagliptin in obese patients with inadequately controlled type 2 diabetes with insulin therapy

作　　者：牟伦盼[1] 蒋建家[1] 苏劲波[1] 张雅萍[1] 林振忠[2] 明德松[2] 

机构地区：[1]福建医科大学附属泉州第一医院内分泌科,362000 [2]福建医科大学附属泉州第一医院检验科362000

出　　处：《中华糖尿病杂志》2016年第1期35-39,共5页CHINESE JOURNAL OF DIABETES MELLITUS

基　　金：泉州市科技计划项目（2010221）

摘　　要：目的评估利拉鲁肽和西格列汀对胰岛素治疗血糖控制欠佳肥胖2型糖尿病患者的疗效和安全性比较。方法选取2013年2月至2014年2月在福建医科大学附属泉州第一医院内分泌科就诊的2型糖尿病患者98例，符合体质指数（BMI〉〉25kg／m2、腰围f男〉90cm，女〉85cm）、糖化血红蛋白（HbA1c）7．5％～9．5％、胰岛素（至少45U／d）联合二甲双胍（至少1000mg／d）治疗超过6个月等条件。按随机数字表法将患者分为利拉鲁肽组（48例）与西格列汀组（50例），两组分别加用利拉鲁肽（第1周0．6mg，后续加至1．2mg）每日1次或西格列汀100mg每日1次。进行为期16周的临床观察，评估治疗前后血糖、体重、血压、血脂谱及不良事件。同一组治疗前后比较采用配对t检验，两组间比较采用成组t检验，率的比较采用X。检验。结果16周时，利拉鲁肽组（41例）与西格列汀组（43例）HbA1c分别为7．4％±0．6％、7．5％±0．7％，较基线8．8％±0．4％、8．7％±0．5％分别下降1．4％±0．4％与1．2％±0．4％，两组下降值比较差异有统计学意义（t=2．5，P〈0．05）；利拉鲁肽组与西格列汀组HbA1c降至7．0％的比例分别为53．7％与37．2％（x2=2.3，P〉0．05）。16周时，利拉鲁肽组体重减轻（2．5±2．4）kg，西格列汀组体重增加（0．3±1．2）kg，两组下降值比较差异有统计学意义（t=6．8，P〈0．01）。16周时，利拉鲁肽组收缩压下降（7．3±6．5）mmHg（1mmHg=0．133kPa），西格列汀组收缩压下降（1．7±3．7）mmHg，两组下降值比较差异有统计学意义（t=4．8，P〈0．01）。16周时，两组血脂谱、血同型半胱氨酸（Hcy）、舒张压较用药前改善（均P〈0．05），但两组间改善幅度差异均无统计学意义（均P〉0．05）。利拉鲁肽组消化道不良事件多于西格列汀组。结论利拉鲁肽与西格列汀对胰岛素治疗血糖�[Abstract] Objective To investigate the efficacy and safety of liraglutide versus sitagliptin in obese patients with inadequately controlled type 2 diabetes with insulin therapy. Methods Ninety-eight cases of type 2 diabetic with body mass index（BMI）〉25 kg/m2, waist circumference（male〉90 cm and female〉 85 cm）, glycated hemoglobin A,^（HbA,o） 7.5%-9.5% were enrolled from February 2013 to February 2014 in Quanzhou First Hospital Affiliated to Fujian Medical University. All subjects who received metformin （at least 1 000 rag/d） and insulin （at least 45 U/d） for at least 6 months were numberally randomly assigned to receive additional liraglutide （0.6 mg for one week followed by 1.2 mg later） once a day （n=48） or sitagliptin 100 mg once a day（n=50） in a 16-week study. Participants were evaluated for glycaemic control, weight, blood pressure, lipid profiles, and adverse events at baseline and 16 weeks. Paired t test was used to analyze changes within groups. Two-sample t test was applied to compare differences of continuous variables between groups. Rates were compared by using the Chi-Square test. Results Compared to the baseline, after 16-week treatment, the HbA1c decreased for 1.4%±0.4% in liraglutide group and for 1.2%±0.4% in sitagliptin group（t=2.5, P〈0.05）. The proportion of patients whose HbAlc reached the target of less than 7.0% was 53.7% and 37.2% in the liraglutide group and sitagliptin group, respectively（x2=2.3, P〉0.05）. After 16- week treatment, weight loss for （2.5 ±2.4） kg was observed in the liraglutide group, while weight gain was reported in the sitagliptin group for （0.3 ± 1.2） kg（t=6.8, P〈0.01）. After 16-week treatment, systolic blood pressure in the liraglutide group reduced for （7.3±6.5） mmHg and for （1.7±3.7） mmHg in sitagliptin group（t= 4.8, P〈0.01）. The improvement of lipid profile, homocysteic acid and diastolic blood pressure after the treatment were all statistically significant in the two groups （all P�

关 键 词：糖尿病 2型 肥胖 胰岛素 利拉鲁肽 西格列汀 

分 类 号：R587[医药卫生—内分泌] R589[医药卫生—内科学]