维格列汀联合二甲双胍对超重2型糖尿病患者心血管疾病危险因素的干预作用

摘要

目的：观察维格列汀联合二甲双胍对超重2型糖尿病患者心血管危险因素的干预作用,评价其有效性及安全性。方法选取2013年10月—2014年3月在沈阳市第四人民医院内分泌科就诊的超重的、二甲双胍单药控制不佳的2型糖尿病患者100例,随机分为观察组(50例)和对照组(50例)。两组先予口服二甲双胍500 mg、2/d,共4周,之后对照组予二甲双胍口服1000 mg、2/d,观察组予口服二甲双胍500 mg、2/d与维格列汀50 mg、2/d,共20周。比较两组治疗前后体重指数、腰围、收缩压、舒张压、糖化血红蛋白( HbA1c)、空腹血糖( FBG)、餐后2 h 血糖(2hPBG)、总胆固醇(TC)、甘油三酯(TG)和低密度脂蛋白胆固醇(LDL-C)、C反应蛋白(CRP)、同型半胱氨酸(Hcy)等指标的变化,及不良反应发生情况。结果治疗后24周,两组FBG、2hPBG、HbA1c均较治疗前降低(P<0．05),观察组较对照组下降更显著(P<0．05)；与治疗前比较,治疗后24周对照组BMI、腰围、Hcy水平显著下降(P<0．05),观察组BMI、腰围、收缩压及血脂、CRP、Hcy水平显著下降(P<0．05),观察组较对照组下降更显著(P<0．05)。两组各类不良反应发生率差异无统计学意义(P>0．05)。结论维格列汀联合二甲双胍治疗超重或肥胖的2型糖尿病可有效控制患者的血糖及体重指数,且不增加低血糖风险,同时也可达到改善血脂、降低血压及抗炎的效果,是超重2型糖尿病患者理想的联合用药方案。%Objective To observe the intervention effect of Vildagliptin combined with Metformin on risk factors of cardiovascular disease in overweight type 2 diabetes mellitus patients, and to evaluate its efficacy and safety. Methods A total of 100 overweight patients with type 2 diabetes mellitus admitted during October 2013 and March 2014, who had failed to respond to Metformin therapy, were randomly divided into treatment group ( n =50 ) and control groups (n=50). All patients were given 500 mg/time Metformin orally (2/d) for 4 weeks, and then the control group was giv-en 1000 mg/time Metformin orally (2/d), while the treatment group was given 500mg/time Metformin (2/d) and 50 mg/time Vildagliptin (2/d) orally for 20 weeks. The changes of body mass index (BMI), waist circumference (W), systolic blood pressure (SBP), diastolic blood pressure (DBP), glycosylated hemoglobinA1c (HbA1c), fasting plasma glucose (FBG), 2 h postprandial blood glucose (2hPBG), total cholesterol (TC), triglyceride (TG), low-density lipo-protein cholesterol (LDL-C), C-reactive protein (CRP), homocysteine (Hcy) and incidence rate of the adverse reac-tions were compared before and after the treatment in the two groups. Results In 24 weeks after treatment, the levels of FBG, 2hPBG and HbA1c were significantly decreases compared with those before the treatment in the two groups ( P<0. 05), and the decreased levels in treatment group were more significant (P<0. 05); compared with those before the treatment, 24 weeks after treatment, the values of BMI, W and Hcy were significantly decreased in control group ( P<0. 05), and the values of BMI, W, SBP, blood fat, CRP and Hcy were significantly decreased in treatment group (P<0. 05), and the decreased levels in treatment group were more significant compared with those in control group (P<0. 05). The difference in incidence rate of adverse reactions was not statistically significant (P>0. 05). Conclusion Vildagliptin combined with Metformin in treatment of overweight patients with type 2 diabetes mellitus can effectively con-trol blood sugar and BMI without increasing the hypoglycemia risk, and at the same time it also can improve blood fat and reduce blood pressure with anti-inflammatory effect.