目的 探討維格列汀聯(lián)合二甲雙胍治療初診2型糖尿病伴腹型肥胖的療效及對(duì)血清吻素（kisspeptin）水平的影響。方法 按前瞻性、隨機(jī)、開(kāi)放、對(duì)照、單中心臨床研究方法設(shè)計(jì)。選取2020年1月—2020年12月在河北醫(yī)科大學(xué)第三醫(yī)院門(mén)診診治的初診2型糖尿病伴腹型肥胖患者，通過(guò)簡(jiǎn)便估算樣本量方法，共計(jì)納入80例患者為研究對(duì)象，按照隨機(jī)數(shù)字表法將80例患者隨機(jī)分為對(duì)照組和試驗(yàn)組，每組40例。對(duì)照組患者服用鹽酸二甲雙胍片，每次1片，每天3次；試驗(yàn)組在對(duì)照組基礎(chǔ)上加用維格列汀，每次1片，每天2次，兩組療程均為3個(gè)月。比較兩組患者治療前后收縮壓（SBP）、舒張壓（DBP）、腰圍、臀圍、腰臀比（WHR）、體質(zhì)量、體質(zhì)量指數(shù)（BMI）、空腹血糖（FPG）、空腹胰島素（FINS）、胰島素抵抗指數(shù)（HOMA-IR）、胰島β細(xì)胞功能指數(shù)（HOMA-β）、糖化血紅蛋白A₁C（HbA₁C）、餐后2 h血糖（2hPG）、三酰甘油（TG）、總膽固醇（TC）、高密度脂蛋白膽固醇（HDL-C）、低密度脂蛋白膽固醇（LDL-C）和血清kisspeptin水平，觀察兩組臨床療效及治療期間不良反應(yīng)的發(fā)生情況。結(jié)果 治療前，對(duì)照組和試驗(yàn)組各項(xiàng)糖脂代謝相關(guān)指標(biāo)比較，組間差異無(wú)統(tǒng)計(jì)學(xué)意義（P>0.05）。治療后，兩組患者SBP、DBP、腰圍、臀圍、WHR、體質(zhì)量、BMI、FPG、2hPG、HOMA-IR、HbA₁C、TG、TC、LDL-C、kisspeptin均較治療前有所下降（P<0.05），且FINS、HOMA-β較治療前有所升高（P<0.05）。治療后，試驗(yàn)組在改善腰圍、臀圍、BMI、FPG、FINS、2hPG、TG、kisspeptin和HOMA-β等指標(biāo)方面，效果優(yōu)于對(duì)照組（P<0.05）。治療后，試驗(yàn)組的總有效率為97.5%，對(duì)照組的總有效率為82.5%，兩組比較差異有統(tǒng)計(jì)學(xué)意義（P<0.05）。治療期間，對(duì)照組患者發(fā)生的不良反應(yīng)為惡心嘔吐2例次，頭疼頭暈1例次；試驗(yàn)組患者發(fā)生的不良反應(yīng)為惡心嘔吐1例次，頭疼頭暈1例次，兩組的總不良反應(yīng)發(fā)生率差異無(wú)統(tǒng)計(jì)學(xué)意義（P>0.05）。結(jié)論 維格列汀聯(lián)合二甲雙胍治療初診2型糖尿病伴腹型肥胖臨床安全有效，患者無(wú)體質(zhì)量增加的風(fēng)險(xiǎn)，兩藥聯(lián)用可以顯著降低血糖水平，改善胰島β細(xì)胞功能，減輕胰島素抵抗，改善脂代謝水平，降低血清kisspeptin水平，不增加藥物不良反應(yīng)發(fā)生率，值得推廣。

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

河北省衛(wèi)生廳指令性項(xiàng)目（20160149）