Kilo Charles, Mezitis Nicholas, Jain Rajeev, Mersey James, McGill Janet, Raskin Philip
Kilo Clinical Research, Limited, 1227 Fern Ridge Parkway, Suite 100, St. Louis, MO 63141, USA.
J Diabetes Complications. 2003 Nov-Dec;17(6):307-13. doi: 10.1016/s1056-8727(03)00076-x.
Transitioning safely to insulin therapy when oral antidiabetic agents fail to provide adequate glycemic control is a critical aspect of care for the patient with type 2 diabetes mellitus (T2DM). We evaluated the clinical effectiveness of starting patients on a relatively simple regimen of once-daily injections of either biphasic insulin aspart 70/30 (10 min before dinner), NPH insulin (at 10 p.m.), or biphasic human insulin 70/30 (30 min before dinner) in combination with metformin. Enrolled patients had T2DM and inadequate glycemic control (AlC>/=7.5%) on a previous regimen of metformin as monotherapy or in combination with a sulphonylurea. One hundred and forty (140) patients received metformin monotherapy for 4 weeks followed by 12 weeks of combination treatment with metformin and once-daily insulin injections. AlC levels decreased from baseline by 1.1-1.3% for patients in each of the three treatment groups. Overall, FPG values decreased from baseline by 31% (biphasic insulin aspart), 37% (NPH insulin), and 28% (biphasic human insulin). Subjects whose final FPG level was <126 mg/dl experienced the largest decreases in AlC values (-2.3%, -1.9%, -1.8%, respectively). All three treatment regimens were well tolerated. The results indicate that patients with T2DM can safely and effectively begin insulin therapy using once-daily injections of biphasic insulin aspart 70/30, biphasic human insulin 70/30, or NPH insulin in combination with metformin.
当口服抗糖尿病药物无法提供足够的血糖控制时,安全过渡到胰岛素治疗是2型糖尿病(T2DM)患者护理的关键环节。我们评估了让患者开始采用相对简单的方案,即每日一次注射门冬胰岛素70/30(晚餐前10分钟)、中性胰岛素(晚上10点)或人胰岛素70/30(晚餐前30分钟)并联合二甲双胍治疗的临床效果。入选患者患有T2DM,且在之前二甲双胍单药治疗或与磺脲类药物联合治疗的方案中血糖控制不佳(糖化血红蛋白≥7.5%)。140例患者接受了4周的二甲双胍单药治疗,随后进行了12周的二甲双胍与每日一次胰岛素注射的联合治疗。三个治疗组中每个组的患者糖化血红蛋白水平均较基线下降了1.1 - 1.3%。总体而言,空腹血糖值较基线分别下降了31%(门冬胰岛素70/30)、37%(中性胰岛素)和28%(人胰岛素70/30)。最终空腹血糖水平<126 mg/dl的受试者糖化血红蛋白值下降幅度最大(分别为-2.3%、-1.9%、-1.8%)。所有三种治疗方案耐受性良好。结果表明,T2DM患者可以安全有效地开始使用每日一次注射门冬胰岛素70/30、人胰岛素70/30或中性胰岛素并联合二甲双胍进行胰岛素治疗。