预混胰岛素类似物每日二次或三次注射疗法治疗严重2型糖尿病的疗效和安全性对比研究

Comparative study on efficacy and safety between premixed insulin aspart 30 reqimens of twice daily versus ingection. triple-daily regimen in treatment of serious type 2 diabetes

目的探讨每日2次或3次皮下注射诺和锐30治疗口服降糖药治疗效果不佳的严重T2DM的疗效及低血糖风险。方法选择56例经两种或两种以上口服降糖药治疗后血糖控制不佳的T2DM患者将其分为诺和锐30二针组(A组)和诺和锐30三针组(B组),停用促进胰岛素分泌的口服降糖药,继续联用二甲双胍治疗,观察12周。比较两组的8个时点血糖(三餐前、三餐后、睡前及3∶00)、一日内最大血糖波动幅度、血糖达标率、低血糖发生率和HbA1c。结果 (1)两组治疗后的8个时点血糖和HbA1c水平均较前明显下降(P<0.01)。(2)B组的午餐后血糖及晚餐前血糖低于A组(P<0.01),其他各点血糖和HbA1c比较差异无统计学意义(P>0.05)。(3)B组血糖达标率优于A组,一日内最大血糖波动幅度及低血糖发生率显著低于A组(P<0.05)。结论对于严重T2DM患者每日3次注射诺和锐30较每日2次注射能更好、更平稳地控制血糖并具有更少的低血糖发生率。

Objective To compare the efficacy and safety between twice-and triple-daily subcutaneous injection of premixed insulin aspart 30（BIAsp30） in serious T2DM patients with failure of oral anti-diabetic drugs（OADs）.Methods Fifty-six patients with inadequate control of hyper-glycemia by OADs were randomized into two groups.Group A was treated with BIAsp30 twice-daily injection,while group B was treated with triple-daily injection.The OADs for promoting the secretion of insulin was stopped except metformin.The treatment lasted for 12 weeks for observation on the changes of blood glucose of 8 time points daily（before and after three meals,before sleep at night,and 3 a.m.）,the maximum amplitude of fluctuation of blood glucose within one day,the targeted rate of blood glucose,incidence of hypoglycemia,and HbA1c in the two groups.Results（1）The levels of blood glucose of 8 time points and HbA1c of both groups were significantly decreased after than before treatment（P〈0.01）.（2）The levels of blood glucose after lunch and before dinner were lower in group B than in group A（P〈0.01）.The levels of blood glucose of other time points and HbA1c of the two groups were not significantly different（P〉0.05）.（3）Group B showed significantly better results than group A in the targeted rate of blood glucose,the maximum amplitude of fluctuation of blood glucose within one day,and incidence of hypoglycemia（P〈0.05）.Conclusion For the serious T2DM patients with failure of OADs,BIAsp30 triple-daily injection is superior to twice-daily injection in controlling blood glucose more steadily and in decreasing the incidence of hypoglycemia.