目的 探讨维格列汀联合二甲双胍治疗初诊2型糖尿病伴腹型肥胖的疗效及对血清吻素（kisspeptin）水平的影响。方法 按前瞻性、随机、开放、对照、单中心临床研究方法设计。选取2020年1月—2020年12月在河北医科大学第三医院门诊诊治的初诊2型糖尿病伴腹型肥胖患者，通过简便估算样本量方法，共计纳入80例患者为研究对象，按照随机数字表法将80例患者随机分为对照组和试验组，每组40例。对照组患者服用盐酸二甲双胍片，每次1片，每天3次；试验组在对照组基础上加用维格列汀，每次1片，每天2次，两组疗程均为3个月。比较两组患者治疗前后收缩压（SBP）、舒张压（DBP）、腰围、臀围、腰臀比（WHR）、体质量、体质量指数（BMI）、空腹血糖（FPG）、空腹胰岛素（FINS）、胰岛素抵抗指数（HOMA-IR）、胰岛β细胞功能指数（HOMA-β）、糖化血红蛋白A₁C（HbA₁C）、餐后2 h血糖（2hPG）、三酰甘油（TG）、总胆固醇（TC）、高密度脂蛋白胆固醇（HDL-C）、低密度脂蛋白胆固醇（LDL-C）和血清kisspeptin水平，观察两组临床疗效及治疗期间不良反应的发生情况。结果 治疗前，对照组和试验组各项糖脂代谢相关指标比较，组间差异无统计学意义（P>0.05）。治疗后，两组患者SBP、DBP、腰围、臀围、WHR、体质量、BMI、FPG、2hPG、HOMA-IR、HbA₁C、TG、TC、LDL-C、kisspeptin均较治疗前有所下降（P<0.05），且FINS、HOMA-β较治疗前有所升高（P<0.05）。治疗后，试验组在改善腰围、臀围、BMI、FPG、FINS、2hPG、TG、kisspeptin和HOMA-β等指标方面，效果优于对照组（P<0.05）。治疗后，试验组的总有效率为97.5%，对照组的总有效率为82.5%，两组比较差异有统计学意义（P<0.05）。治疗期间，对照组患者发生的不良反应为恶心呕吐2例次，头疼头晕1例次；试验组患者发生的不良反应为恶心呕吐1例次，头疼头晕1例次，两组的总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初诊2型糖尿病伴腹型肥胖临床安全有效，患者无体质量增加的风险，两药联用可以显著降低血糖水平，改善胰岛β细胞功能，减轻胰岛素抵抗，改善脂代谢水平，降低血清kisspeptin水平，不增加药物不良反应发生率，值得推广。

Objective To investigate the efficacy of vigliptin combined with metformin in treatment of newly diagnosed abdominal obese type 2 diabetes mellitus and its effect on serum level of kisspeptin. Methods A prospective, randomized, open, controlled, single center clinical study was conducted. A total of 80 patients with newly diagnosed abdominal obesity type 2 diabetes mellitus were selected and randomly divided into control group and experimental group. Patients in the control group took Metformin Hydrochloride Tablets, one tablet each time, three times a day. On the basis of the control group, patients in the experimental group were treated with vigliptin, one tablet each time, twice a day. The course of treatment of both groups was three months. Systolic blood pressure (SBP), diastolic blood pressure (DBP), waist circumference, hip circumference, waist hip ratio (WHR), body mass, body mass index (BMI), fasting blood glucose (FPG), fasting insulin (FINS), insulin resistance index (HOMA-IR) and islet β cell function index (HOMA- β), glycosylated hemoglobin A₁C (HbA₁C), 2-hour postprandial blood glucose (2hPG), triglyceride (TG), total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C) and serum kisspeptin levels were observed to observe the clinical efficacy of the two groups and the occurrence of adverse reactions during treatment. Results Before treatment, there was no significant difference between the control group and the experimental group (P > 0.05). After treatment, SBP, DBP, waist circumference, hip circumference, WHR, body mass, BMI, FPG, 2hPG, HOMA-IR, HbA₁C, TG, TC, LDL-C and kisspeptin in the two groups decreased compared with those before treatment (P<0.05), and FINS and HOMA-β were higher than that before treatment (P<0.05). After treatment, the experimental group improved waist circumference, hip circumference, BMI, FPG, FINS, 2hPG, TG, kisspeptin and HOMA-β, and the effect of these indexes was better than that of the control group (P<0.05). After treatment, the total effective rate was 97.5% in the experimental group and 82.5% in the control group. There was significant difference between the two groups (P<0.05). During the treatment, the adverse reactions in the control group were nausea and vomiting in 2 cases, headache and dizziness in 1 case. The adverse reactions of the patients in the experimental group were nausea and vomiting for 1 case and headache and dizziness for 1 case. There was no significant difference in the total adverse reaction rate between the two groups (P > 0.05). Conclusion The combination of vilagliptin and metformin is safe and effective in the treatment of newly diagnosed type 2 diabetes mellitus with abdominal obesity. The patients have no risk of increasing body mass. The combination of the two drugs can significantly reduce the blood glucose level and improve the islet of langerhans β cell function, reduce insulin resistance, improve the level of lipid metabolism, reduce the level of serum kisspeptin, and do not increase the incidence of adverse drug reactions. It is worth promoting.

R977

河北省卫生厅指令性项目（20160149）