甘精胰岛素、NPH胰岛素联合口服降糖药在2型糖尿病患者中的应用

目的在口服药物治疗的2型糖尿病病人中,比较加用甘精胰岛素或人NPH胰岛素使HbAlc达到7%的疗效和低血糖风险。方法在33例服用一种或2种口服降糖药但血糖控制仍然不良的2型糖尿病患者(HbAlc>7.5%)中,进行了这一随机、开放标记、平行、16周的试验,患者继续服用研究前的药物,但于每天睡前加用一次甘精胰岛素或人NPH胰岛素,使空腹血糖(FBG)达到≤100mg/dl(5.6mmol/L)的目标值。试验结果的观察指标为FBG、HbAlc、低血糖发生率和达到HbAlc≤7%并且没有发生有记录的夜间低血糖的患者百分数。结果终点时甘精胰岛素组和NPH胰岛素组的平均FBG(5.94Vs6.11mol/L)和HbAlc(6.68Vs6.79%)无明显差异,P>0.05。大多数用这两种胰岛素的患者都达到HbAlc≤7%的目标。但是,在HbAlc≤7%且没有发生有记录的低血糖(<4mmol/L)方面,甘精胰岛素组(69%)比NPH组(29%)高出一倍,P<0.05。甘精胰岛素组的经证实的夜间低血糖发生率也显著低于NPH组,P<0.05。结论口服降糖药治疗且血糖控制不良的2型糖尿病患者,睡前加用基础胰岛素,可使绝大多数患者血糖获得理想控制(HbAlc≤7%)。甘精胰岛素的夜间低血糖发生率明显低于NPH胰岛素。

Oral therapy combined with bedtime insulin glargine or bedtimeNPH insulin in patients with type 2 diabetes

Objective To compare the abilities and associated hypoglycemia risks of insulin glargine and human NPH insulin added to oral therapy of type 2 diabetes to achive HbAlc less than 7%.Methods In a randomized, open-label, parallel, 16-week trial, 33 patients with inadequate glycemic control (HbAlc>7.5%)on one or two oral agents continued prestudy oral agents and received bedtime glargine or NPH once daily, in order to seek a target fasting plasma glucose (FPG)≤5.6mmol/l. Outcome measures were FPG, HbAlc, hypoglycemia, and percentage of patients reaching HbAlc≤7% without documented nocturnal hypoglycemina.Results Mean FPG at end point was simlar with glargine and NPH (5.94Vs6.11mmol/l), as was HbAlc (6.68Vs6.79%), P>0.05. A majority of patients (above 70%) attained HbAlc≤7%with each insulin type. However, above one times more patients attained this without documented nocturnal hypoglycemia(<4.0mmol/l) with glargine (69vs29%)P<0.05. Moreover, rates of symptomatic hypoglycemia were significantly lower with glargine. Conclusion Bedtime basal insulin added to oral therapy can safely achieve HbAlc less than 7% in majority of patients with type 2 diabetes with HbAlc>7.5% on oral agents alone. In doing this, glargine causes significantly less nocturnal hypoglycemia than NPH.