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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P<0.05),组间差异均无统计学意义(均P>0.05)。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(P>0.05)。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P<0.05)。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(P<0.05)。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。
Objective To observe the clinical efficacy and safety of exenatide injection in overweight and obese type 2 diabetic patients with poor blood glucose control. Methods Sixty-two patients with type 2 diabetes who were poorly controlled by two or more antidiabetic drugs were randomly divided into test group and control group, with 31 cases in each group. The control group was injected subcutaneously with insulin aspart 30 injection at breakfast and before meals. The initial dose was determined by the investigators according to the clinical experience. Exenatide 5 μg was administered to the experimental group subcutaneously 1 h before and after meals, which could be tolerated for 1 month Later changed to 10μg. Both groups were treated for 16 weeks. Body mass, body mass index (BMI), blood pressure, FPG, 2 h PG, Hb A1c, Islet β cell resistance index (HOMA-IR) and other indicators change, and the two groups of adverse drug reactions and hypoglycemia were observed. Results After treatment, the FPG in the test group was (6.83 ± 1.03) mmol·L -1 and that in the control group was (6.61 ± 0.97) mmol·L -1; the PG level in the test group was (9.02 ± 1.17) (9.77 ± 1.43) mmol·L -1 in the control group; the Hb A1c in the experimental group was (7.24 ± 1.23)% and that in the control group was (7.07 ± 1.03)%, Before comparison, the difference was statistically significant (all P <0.05), there was no significant difference between the two groups (all P> 0.05). The triglyceride (TG) was (1.98 ± 0.88) mmol·L -1 in the test group and (2.33 ± 1.25) mmol·L -1 in the control group. The LDL- (3.37 ± 0.71) mmol·L -1 in the control group and (3.70 ± 0.81) mmol·L -1 in the control group. The HOMA-IR of the experimental group was 4.23 ± 2.64 and that of the control group was 4.63 ± 3.10, The experimental group compared with before treatment, the difference was not statistically significant (P> 0.05). The body weight of the test group was (76.70 ± 8.20) kg and that of the control group was (84.90 ± 8.10) kg. The BMI of the test group was (26.14 ± 4.32) cm and the control group was (99.87 ± 7.43) ) kg · m -2, while the control group was (30.49 ± 4.52) kg · m -2. There was significant difference between the two groups (all P <0.05). There were no serious adverse reactions occurred in the two groups during the treatment period. There were 8 cases (25.81%) of mild gastrointestinal reactions, 1 case of pruritus (3.23%) and 1 case of hypoglycemia (3.23%) in the test group. There were 1 case (3.23%) of induration and 8 cases of hypoglycemia (25.81%), the difference was statistically significant (P <0.05). Conclusions Exenatide injection is effective in treating overweight and obese type 2 diabetic patients with poor glycemic control of oral hypoglycemic agents, which can effectively reduce blood glucose and have the advantage of reducing hypoglycemic effects such as reducing waist circumference, body weight, blood lipids and improving insulin sensitivity , And low risk of hypoglycemia.