双时相门冬胰岛素30与预混人胰岛素30R治疗2型糖尿病的疗效及安全性比较

Comparison of efficacy and safety of insulin aspart 30 injection and isophane protamine biosynthetic human insulin Injection for type 2 diabetes

目的比较双时相门冬胰岛素30和预混人胰岛素30R治疗2型糖尿病(T2DM)的疗效及安全性。方法将本院2007年1月至2010年5月住院的80例T2DM患者采用简单随机方法分为两组,其中预混人胰岛素30R治疗40例(A组),双时相门冬胰岛素30治疗40例(B组),均采用每日早、晚餐前两次皮下注射方案,为期12周,比较两组患者空腹、早餐后2 h、午餐前、午餐后2 h、晚餐前、晚餐后2 h及睡前7个时点血糖的变化,糖化血红蛋白(HbA1 c)及血糖控制达标所需要的胰岛素用量、低血糖事件、不良反应发生率。结果 B组三餐后血糖、HbA1 c、低血糖事件发生率均低于A组,差异有统计学意义(P<0.05);两组胰岛素用量及其他不良事件发生率差异无统计学意义(P>0.05)。结论双时相门冬胰岛素30能有效降低餐后血糖,且低血糖事件发生率低,是一种简便、有效、安全的治疗方法。

Objective To compare the efficacy and safety between Insulin Aspart 30 Injection and Isophane Protamine Biosynthetic Human Insulin Injection（pre-mixed 30R） in the treatment of type 2 diabetes（T2DM）.Methods Eighty patients with T2DM,which were hospitalized in the Chengdu Aerospace Hospital from January 2007 to May 2010,were randomly divided into two groups,group A（40 cases） and group B（40 cases）.Patients in group A received pre-mixed 30R b.i.d,and those in group B received Insulin Aspart 30 Injection b.i.d.And a 12-week controlled trial was performed.Changes in blood glucose at 7 time points（early morning/fasting,2h after breakfast,before lunch,2h after lunch,before dinner,2h after dinner and bedtime）,glycosylated hemoglobin（HbA1c）,insulin dosage,incidence of hypoglycemia and other adverse events were observed.Results Postprandial blood glucose levels,HbA1c and hypoglycemia incidence in group B were significantly lower than those in group A（P0.05）.There was no significant difference in insulin dosage between the two groups（P0.05）.Conclusion Insulin Aspart 30 Injection can efficiently reduce postprandial blood glucose,with low incidence of hypoglycemia and other adverse events,compared with pre-mixed 30R,which is an effective and safe drug for T2DM.