艾塞那肽注射液对血糖控制不佳的超重和肥胖2型糖尿病患者的临床研究

发布时间：2018-11-27 14:38

【摘要】：目的观察艾塞那肽注射液对血糖控制不佳的超重和肥胖2型糖尿病患者的临床疗效和安全性。方法 62例口服2种及以上降糖药物血糖控制不佳的2型糖尿病患者,随机分为试验组和对照组,各31例。对照组早晚餐前皮下注射门冬胰岛素30注射液,起始剂量由研究者根据临床经验判断;试验组给予艾塞那肽5μg,早晚餐前1 h皮下注射,能耐受治疗的1个月后改为10μg。2组均治疗16周。观察2组患者治疗前后腰围、体重、体重指数(BMI)、血压、空腹血糖(FPG)、餐后2 h血糖(2 h PG)、糖化血红蛋白(Hb A1c)、血脂和空腹胰岛素(FINS)、胰岛β细胞抵抗指数(HOMA-IR)等指标变化,并观察2组药物不良反应和低血糖等发生情况。结果治疗后,试验组FPG为(6.83±1.03)mmol·L~(-1),对照组为(6.61±0.97)mmol·L~(-1);试验组2 h PG为(9.02±1.17)mmol·L~(-1),对照组为(9.77±1.43)mmol·L~(-1);试验组Hb A1c为(7.24±1.23)%,对照组为(7.07±1.03)%,与治疗前比较,差异均有统计学意义(均P0.05),组间差异均无统计学意义(均P0.05)。试验组三酰甘油(TG)为(1.98±0.88)mmol·L~(-1),对照组为(2.33±1.25)mmol·L~(-1);试验组低密度脂蛋白胆固醇(LDL-C)为(3.37±0.71)mmol·L~(-1),对照组为(3.70±0.81)mmol·L~(-1),试验组HOMA-IR为4.23±2.64,对照组4.63±3.10,试验组与治疗前相比,差异无统计学意义(P0.05)。试验组腰围为(94.53±6.73)cm,对照组为(99.87±7.43)cm;试验组体重为(76.70±8.20)kg,对照组为(84.90±8.10)kg;试验组BMI为(26.14±4.32)kg·m~(-2),对照组为(30.49±4.52)kg·m~(-2),差异均有统计学意义(均P0.05)。治疗期间2组均无严重不良反应发生,试验组出现轻度胃肠道反应8例(25.81%),皮肤瘙痒1例(3.23%),低血糖事件1例(3.23%);对照组出现皮下注射处硬结1例(3.23%),低血糖事件8例(25.81%),差异有统计学意义(P0.05)。结论艾塞那肽注射液治疗口服降糖药血糖控制不佳的超重和肥胖2型糖尿病患者疗效显著,可有效降低血糖,并有降低腰围、体重、血脂和改善胰岛素敏感性等降糖外优势,且低血糖发生风险低。
[Abstract]:Objective to observe the clinical efficacy and safety of Isenapeptide injection in patients with type 2 diabetes mellitus with poor blood glucose control. Methods Sixty-two patients with type 2 diabetes mellitus who were not well controlled by two or more hypoglycemic drugs were randomly divided into trial group and control group (31 cases each). In the control group, subcutaneously injected aspartic insulin 30 injection was given in the morning and evening before meal, and the initial dose was judged by the clinical experience. The experimental group was given 5 渭 g of Isenapeptide, subcutaneously injected 1 hour before meal in the morning and evening, and changed to 10 渭 g / 2 group for 16 weeks after 1 month of tolerant treatment. The waist circumference, body mass index (BMI),) blood pressure, fasting blood glucose (FPG),) 2 h postprandial blood glucose (2 h PG), glycosylated hemoglobin (Hb A1c), blood lipid and fasting insulin (FINS),) were observed before and after treatment. The changes of islet 尾 cell resistance index (HOMA-IR), adverse drug reactions and hypoglycemia were observed. Results after treatment, FPG was (6.83 卤1.03) mmol L ~ (-1) in the experimental group and (6.61 卤0.97) mmol L ~ (-1) in the control group. The PG was (9.02 卤1.17) mmol L ~ (-1) in the experimental group and (9.77 卤1.43) mmol L ~ (-1) in the control group. The Hb A1c was (7.24 卤1.23)% in the experimental group and (7.07 卤1.03)% in the control group. Triglyceride (TG) was (1.98 卤0.88) mmol L ~ (-1) in the experimental group and (2.33 卤1.25) mmol L ~ (-1) in the control group. Low density lipoprotein cholesterol (LDL-C) was (3.37 卤0.71) mmol L ~ (-1) in the experimental group, (3.70 卤0.81) mmol L ~ (-1) in the control group, and 4.23 卤2.64 in the experimental group, and 4.63 卤3.10 in the control group. There was no significant difference between the experimental group and before treatment (P0.05). The waist circumference of the trial group was (94.53 卤6.73) cm, control group was (99.87 卤7.43) cm; test group, the weight of the test group was (76.70 卤8.20) kg, control group was (84.90 卤8.10) kg;. The BMI of the experimental group was (26.14 卤4.32) kg m2, while that of the control group was (30.49 卤4.52) kg m2, the difference was statistically significant (P0.05). There were no serious adverse reactions in both groups. Mild gastrointestinal reaction occurred in 8 cases (25.81%), pruritus in 1 case (3.23%) and hypoglycemia in 1 case (3.23%) in the trial group. In the control group, there were 1 case (3.23%) with subcutaneous injection and 8 cases (25.81%) with hypoglycemia. The difference was statistically significant (P0.05). Conclusion Isenapeptide injection is effective in the treatment of overweight and obese type 2 diabetes patients who are not well controlled by oral hypoglycemic drugs. It can effectively reduce blood glucose, and has the advantages of reducing waist circumference, body weight, blood lipid and improving insulin sensitivity. The risk of hypoglycemia is low.
【作者单位】：金华市中心医院内分泌科;浙江省立同德医院内分泌科;
【基金】：浙江省医药卫生一般研究计划基金资助项目(2014KYB046)
【分类号】：R587.1;R589.2

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