胰岛素类似物联合口服降糖药治疗2型糖尿病

Insulin analogs combined with oral antidiabetic drugs in treating patients with type 2 diabetes mellitus

摘要:

目的：评估3种胰岛素类似物（地特胰岛素、甘精胰岛素、双相门冬胰岛素30）联合口服降糖药用于治疗血糖控制欠佳的2型糖尿病患者的有效性及安全性。方法：73例血糖控制不达标的2型糖尿病患者被分为3组：每日睡前1次地特胰岛素组（n=23），每日睡前1次甘精胰岛素组（n=27）和每日早晚餐前各1次双相门冬胰岛素30组（n=23），各组均联合使用口服降糖药，共治疗16周。分析比较3组患者治疗前后糖化血红蛋白（hemoglobin A1c，HbA1c）、空腹血糖（fasting blood glucose，FBG）、餐后血糖（postprandial blood glucose，PBG）、体质指数（body mass index，BMI）的变化。评估3组间HbA1c 、FBG、PBG下降幅度、HbA1c达标率（<7%）和低血糖事件的发生率。结果：治疗前3组HbA1c、FBG、PBG均无显著差异。经16周治疗，3组HbA1c、FBG、PBG 均较治疗前显著下降（P<0.01），但组间比较无显著差异（P >0.05）。各组治疗前后BMI均无显著变化（P >0.05）。地特胰岛素组、甘精胰岛素组、双相门冬胰岛素30组HbA1c达标率（<7%）分别为43%、59%、52%，组间比较无显著差异（P >0.05）。地特胰岛素组、甘精胰岛素组、双相门冬胰岛素30组分别发生3例（13%）、2例（7%）、5例（22%）轻度低血糖，均无严重低血糖事件发生，各组间低血糖发生率无显著差异（P >0.05）。结论：在本研究人群中，有效控制FBG是HbA1c降低及达标的有效手段，3种胰岛素类似物联合口服降糖治疗2型糖尿病，可达到同样的降糖效果，并且体质量无明显增加、低血糖发生率较低。

Abstract:

Objective：To evaluate the efficacy and safety of insulin analogs（Insulin detemir，Insulin glargine，Biphasic insulin aspart 30） combined with oral antidiabetic drugs（OADs） in treating type 2 diabetic mellitus patients whose blood glucose is insufficiently con－trolled. Methods：Seventy-three type 2 diabetic mellitus patients with insufficiently controlled blood glucose were assigned to three groups：group treated with Insulin detemir once daily before bedtime（Insulin detemir group，n=23），group treated with Insulin glargine once daily before bedtime（Insulin glargine group，n=27），group treated with Biphasic insulin aspart 30 twice daily before breakfast and dinner（BIAsp30 group，n=23）. All patients were treated with OADs for 16 weeks. Hemoglobin A1c（HbA1c），fasting blood glucose（FBG），body mass index（BMI） were measured pre-treatment and after-treatment. Reductions of HbA1c，FBG and postprandial blood glucose（PBG），compliance rates of HbA1c（<7%） and incidences of hypoglycemia were compared. Results：There was no significant differences among three groups in HbA1c，FBG and PBG levels before the therapy. At the end of 16 weeks，HbA1c，FBG，PBG were decreased significantly in three groups（P<0.01），and there was no difference in reduction of HbA1c，FBG，PBG among three groups（P >0.05）. BMI did not change significantly pre-treatment and after-treatment in all groups. Compliance rates of HbA1c < 7% were 43%，59%，52% in Insulin detemir group，Insulin glargine group and BIAsp 30 group respectively. There was no difference in compliance rate of HbA1c<7% among three groups（P >0.05）. 3 patients（13%），2 patients（7%），5 patients（22%） had mild hypoglycemia in three groups respectively，but the incidence of hypoglycemia was not significantly different among three groups（P >0.05）. No severe hypo－glycemia happened in all groups. Conclusions：Effective control of FBG is important in decreasing HbA1c for type 2 diabetic mellitus patients whose blood glucose is insufficiently controlled. All three kinds of insulin analogs combined with OADs can decrease blood glucose without weight gain and hypoglycemia episode increase.