司美格鲁肽联合二甲双胍治疗超重或肥胖2型糖尿病患者的临床研究  

Clinical trial of semaglutide combined with metformin in the treatment of overweight or obese patients with type 2 diabetes mellitus

作　　者：张凤丽[1] 赵一楠[1] 孙建武[2] 文丽娜[1] 陶红[1] ZHANG Feng-li;ZHAO Yi-nan;SUN Jian-wu;WEN Li-na;TAO Hong(Department of Endocrinology and Metabolism,Beijing Anzhen Hospital,Capital Medical University,Beijing 100029,China;Clinical Laboratory,Beijing Anzhen Hospital,Capital Medical University,Beijing 100029,China)

机构地区：[1]首都医科大学附属北京安贞医院内分泌代谢科,北京100029 [2]首都医科大学附属北京安贞医院检验科,北京100029

出　　处：《中国临床药理学杂志》2023年第15期2164-2168,共5页The Chinese Journal of Clinical Pharmacology

基　　金：中华国际医学交流基金会-国际糖尿病交流与实践专项基金森美中华糖尿病科研基金资助项目(Z-2017-26-1902-4)。

摘　　要：目的观察司美格鲁肽注射剂联合二甲双胍片治疗超重或肥胖2型糖尿病(T2DM)患者的临床疗效及安全性。方法将超重或肥胖T2DM患者按随机数表法分为对照组和试验组。对照组口服二甲双胍,每次1.0 g,每天2次;试验组在对照组治疗的基础上,注射司美格鲁肽,每周1次,起始剂量为每周0.25 mg,4周后增至每周0.5 mg,每周0.5 mg治疗4周后剂量增至每周1 mg。2组均持续治疗3个月后观察疗效。比较2组治疗前后糖代谢、体质量指数(BMI)、脂代谢、血清学指标变化情况、肝功能及药物不良反应发生情况。结果对照组和试验组分别入组86例和88例患者。治疗后,试验组和对照组的空腹血糖分别为(7.54±1.12)和(8.06±1.23)mmoL·L^(-1),餐后2 h血糖分别为(9.83±1.67)和(10.95±1.86)mmoL·L^(-1),糖化血红蛋白分别为(5.62±0.49)%和(7.04±0.53)%,胰岛素抵抗指数分别为2.14±0.38和2.53±0.41,BMI分别为(24.79±1.61)和(25.64±1.59)kg·m^(-2),三酰甘油分别为(1.99±0.37)和(2.28±0.41)mmoL·L^(-1),总胆固醇分别为(5.34±0.86)和(5.66±0.92)mmoL·L^(-1),低密度脂蛋白胆固醇分别为(3.41±0.52)和(3.69±0.58)mmoL·L^(-1),成纤维细胞生长因子21(FGF21)分别为(4.01±0.47)和(5.76±0.69)mmoL·L^(-1),蛋白酪氨酸磷酸酶1B(PTP1B)分别为(3.02±0.54)和(3.53±0.61)μg·L^(-1),胰岛素样生长因子(IGF)分别为(158.13±8.96)和(167.59±10.13)mmoL·L^(-1),差异均有统计学意义(均P<0.05)。试验组和对照组总药物不良反应发生率分别为2.27%和3.49%,差异无统计学意义(P>0.05)。结论司美格鲁肽注射剂联合二甲双胍片治疗超重或肥胖T2DM患者可有效控制体质量,改善糖脂代谢及胰岛素抵抗水平,抑制FGF21、PTP1B、IGF分泌,且安全性良好。Objective To investigate the clinical efficacy and safety of semaglutide combined with metformin in the treatment of overweight or obese patients with type 2 diabetes mellitus(T2DM).Methods Overweight or obese patients with T2DM were divided into control group and treatment group according to the random number table method.The control group was given oral metformin,1.0 g each time,twice a day.The treatment group was injected with semaglutide on the basis of control group,once a week,the initial dose was 0.25 mg per week,which increased to 0.5 mg per week after 4 weeks,and the dose increased to 1 mg per week after 4 weeks of treatment with 0.5 mg per week.The curative effect was observed after 3 months of continuous treatment in both groups.The changes of glucose metabolism,body mass index(BMI),lipid metabolism,serological indexes,liver function and the occurrence of adverse drug reactions were compared between the two groups before and after treatment.Results There were 86 cases in the control group and 88 cases in the treatment group.After treatment,the fasting plasma glucose of the treatment group and the control group were(7.54±1.12)and(8.06±1.23)mmol·L^(-1);2-hour post-prandial glucose were(9.83±1.67)and(10.95±1.86)mmoL·L^(-1);glycosylated hemoglobin were(5.62±0.49)%and(7.04±0.53)%;insulin resistance indexes were 2.14±0.38 and 2.53±0.41;the BMI were(24.79±1.61)and(25.64±1.59)kg·m^(-2),the triglyceride were(1.99±0.37)and(2.28±0.41)mmol·L^(-1);total cholesterol were(5.34±0.86)and(5.66±0.92)mmoL·L^(-1);low-density lipoprotein cholesterol were(3.41±0.52)and(3.69±0.58)mmoL·L^(-1);the fibroblast growth factor 21(FGF21)were(4.01±0.47)and(5.76±0.69)mmoL·L^(-1);protein tyrosine phosphatase 1B(PTP1B)were(3.02±0.54)and(3.53±0.61)μg·L^(-1);insulin-like growth factor(IGF)were(158.13±8.96)and(167.59±10.13)mmoL·L^(-1),there were significant different between the two groups(all P<0.05).The incidence of total adverse drug reactions in the treatment group and the control group were 2.27%and 3.49

关 键 词：司美格鲁肽注射剂 二甲双胍片 超重/肥胖 2型糖尿病 临床疗效 

分 类 号：R977.15[医药卫生—药品]