Skrha J, Smahelová A, Andĕl M, Vrtovec M, Subić J, Kreze A, Vozar J, Korecová M, de Verga V, Wyatt J, Metcalfe S, Ristić S
Third Department of Internal Medicine of First Medical Faculty, Charles University, Czech Republic.
Sb Lek. 2002;103(1):15-21.
Insulin lispro was compared with regular human insulin with respect to glycaemic control in patients with diabetes mellitus on intensive insulin treatment. Sixty-two patients (55 type 1; 7 type 2) from eight study centres in the Czech Republic, Slovenia and the Slovak Republic participated in a 4-month, open-label, randomized, crossover study. Patients administered insulin lispro immediately before meals or regular human insulin 30 min before meals. A test meal (220-400 kcal), based on local and individual dietary habits and consistent for each patient throughout the study was given at baseline and at the end of each treatment. At each test meal visit HbA1c, fasting blood glucose, 1-hour and 2-hour postprandial blood glucose levels were measured. The level of HbA1c (7.6% +/- 1.5% versus 7.4% +/- 1.5%), incidence of hypoglycaemia (41-66% of patients--versus 39-63%) and daily insulin dose (0.67 +/- 0.11 U/kg versus 0.65 +/- 0.11 U/kg) did not differ between treatment groups at endpoint (insulin lispro versus regular human insulin, respectively). Mean 2-hour postprandial blood glucose excursion for the insulin lispro group (0.0 +/- 3.7 mmol/L) was significantly lower (p = 0.035) when compared with the regular human insulin group (1.3 +/- 3.7 mmol/L) at endpoint. Therapy with insulin lispro was therefore associated with a significant improvement in postprandial blood glucose excursion control when compared with regular human insulin, without an increase in rate of hypoglycaemia.
在接受强化胰岛素治疗的糖尿病患者中，比较了赖脯胰岛素与常规人胰岛素在血糖控制方面的效果。来自捷克共和国、斯洛文尼亚和斯洛伐克共和国八个研究中心的62名患者（55例1型糖尿病；7例2型糖尿病）参与了一项为期4个月的开放标签、随机、交叉研究。患者在饭前立即注射赖脯胰岛素或在饭前30分钟注射常规人胰岛素。根据当地和个人饮食习惯，为每位患者提供一份测试餐（220 - 400千卡），且在整个研究过程中保持一致，分别在基线和每次治疗结束时提供。在每次测试餐就诊时，测量糖化血红蛋白（HbA1c）、空腹血糖、餐后1小时和2小时血糖水平。在研究终点时，治疗组之间的糖化血红蛋白水平（7.6%±1.5%对7.4%±1.5%）、低血糖发生率（41 - 66%的患者对39 - 63%）和每日胰岛素剂量（0.67±0.11 U/kg对0.65±0.11 U/kg）没有差异（分别为赖脯胰岛素组和常规人胰岛素组）。与常规人胰岛素组相比，赖脯胰岛素组在研究终点时的餐后2小时血糖平均波动幅度（0.0±3.7 mmol/L）显著更低（p = 0.035）（常规人胰岛素组为1.3±3.7 mmol/L）。因此，与常规人胰岛素相比，赖脯胰岛素治疗在餐后血糖波动控制方面有显著改善，且低血糖发生率没有增加。
