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

摘要

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(HbA1c)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、HbA1c、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, HbA1cand hypoglycemia incidence in group B were significantly lower than those in group A ( P ＜ 0.05 ).There was no significant difference in insulin dosage between the two groups ( P ＞ 0.05 ).Conclusion Insulin Aspart 30 Injection can efficiently reduce postprandial blood glucose,with iow incidence of hypoglycemia and other adverse events, compared with pre-mixed 30R, which is an effective and safe drug for T2DM.