重组赖脯胰岛素联合重组甘精胰岛素治疗2型糖尿病的疗效及安全性

发布时间：2018-09-08 17:04

【摘要】：目的：比较重组赖脯胰岛素注射液(江苏万邦公司)与赖脯胰岛素注射液(礼来制药公司)在2型糖尿病(Type 2 diabetes mellitus,T2DM)治疗中的临床疗效和安全性。方法：将血糖控制不佳的T2DM患者随机分为试验组(重组赖脯胰岛素组)(n=32)和对照组(赖脯胰岛素组)(n=16),试验组予三餐前皮下注射重组赖脯胰岛素(江苏万邦),睡前皮下注射重组甘精胰岛素(长秀霖)；对照组予餐前皮下注射赖脯胰岛素(礼来),睡前皮下注射重组甘精胰岛素注射液(长秀霖)。治疗周期为16周,比较两组治疗前后糖化血红蛋白(HbA1c)、空腹血糖(FPG)、餐后2小时血糖(2hPG)水平,血常规、尿常规、肝功能、肾功能、血脂、胰岛素抗体、体重、腰围、臀围、收缩压、舒张压等值变化以及胰岛素剂量、不良事件和低血糖事件的发生率。结果：44例完成治疗随访观察,试验组完成28例,对照组完成16例；治疗16周后,两组患者HbA1c、FPG和2hPG水平均均显著降低(P0.05),但两组间下降程度无显著性差异(P0.05)。试验组治疗前后血脂无显著差异,而对照组TC和LDL-C显著降低(P0.05)；试验组治疗后BMI和WHR较基线显著增加(P0.05),对照组WHR较基线显著增加(P0.05), BMI治疗后虽有增加趋势,但差异无统计学意义；两组治疗前后体重增加程度无显著差异(P0.05)。两组血常规、肝功能、肾功能、胰岛素抗体、血压治疗前后无显著差异；低血糖发生率两组无显著差异(P0.05),两组均未发生严重低血糖事件。结论：重组赖脯胰岛素注射液(江苏万邦)与赖脯胰岛素注射液(礼来制药公司)在治疗T2DM方面具有相同的有效性和安全性。
[Abstract]:Objective: to compare the clinical efficacy and safety of recombinant Levine insulin injection (Jiangsu Wanbang Company) and Lilai injection (Lilai Pharmaceutical Company) in the treatment of type 2 diabetes mellitus (Type 2 diabetes mellitus,T2DM). Methods: patients with T2DM with poor blood glucose control were randomly divided into two groups: the experimental group (recombinant proline insulin group) and the control group (the control group) (nni16). The experimental group was subcutaneously injected with recombinant proline insulin (Jiangsu Wanbang) before three meals, and the skin before bedtime was given. Injection of recombinant insulin glargine (Changxiulin); The control group was subcutaneously injected with proline (Lilly) before meal, and the control group was subcutaneously injected with recombinant insulin glargine (Changxiulin) before bedtime. The treatment cycle was 16 weeks. The levels of glycosylated hemoglobin (HbA1c), blood glucose (2hPG), blood routine, urine routine, liver function, renal function, blood lipids, insulin antibody, body weight, waist circumference, hip circumference, systolic blood pressure were compared between the two groups before and after treatment. Changes in diastolic blood pressure and the incidence of insulin dose, adverse events, and hypoglycemia events. Results 44 cases were followed up, 28 cases in the trial group and 16 cases in the control group. After 16 weeks of treatment, the levels of HbA1c,FPG and 2hPG decreased significantly in both groups (P0.05), but there was no significant difference between the two groups (P0.05). There was no significant difference in serum lipids before and after treatment in the trial group, but TC and LDL-C in the control group decreased significantly (P0.05), BMI and WHR in the experimental group increased significantly compared with the baseline (P0.05), WHR in the control group increased significantly compared with the baseline (P0.05), BMI after treatment). But the difference was not statistically significant; there was no significant difference in weight gain between the two groups before and after treatment (P0.05). There was no significant difference in blood routine, liver function, renal function, insulin antibody, blood pressure before and after treatment. There was no significant difference in the incidence of hypoglycemia between the two groups (P0.05). Conclusion: Recombinant proline insulin injection (Jiangsu Wanbang) has the same efficacy and safety in the treatment of T2DM.
【学位授予单位】：重庆医科大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：R587.1

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