Sonnenberg G E, Kemmer F W, Cüppers H J, Berger M
Diabetes Care. 1983 Mar-Apr;6 Suppl 1:35-9.
The absorption kinetics of human insulin (Novo) were studied and compared with those of purified porcine insulin preparations in seven healthy men. The absorption of insulin after subcutaneous injection of human insulin (Actrapid, Novo) was significantly accelerated and its hypoglycemic effect significantly stronger when compared with porcine insulin (Actrapid). No differences in the absorption kinetics were observed using human insulin (Monotard, Novo) and porcine insulin (Monotard) preparations, respectively. A clinical trial was designed to determine whether the pharmacokinetic differences were relevant for the clinical use of regular human insulin. The efficacy of human and porcine insulin (Actrapid) was tested in a double-blind crossover protocol in 12 type I diabetic patients treated with continuous subcutaneous insulin infusion. Near-normoglycemia was achieved with both types of insulin. Diurnal blood glucose values and excursions, insulin requirements, the frequency of mild hypoglycemic episodes, and the carbohydrate content of the diet were essentially identical. Thus, the differences between the absorption of human insulin and porcine regular insulin from a subcutaneous depot as observed in the pharmacokinetic studies in normal man do not appear to be relevant in the clinical practice of the subcutaneous insulin replacement therapy in type I diabetes mellitus at near-normoglycemia.
对7名健康男性研究了人胰岛素(诺和诺德公司生产)的吸收动力学,并与纯化猪胰岛素制剂的吸收动力学进行了比较。与猪胰岛素(Actrapid)相比,皮下注射人胰岛素(诺和诺德公司生产的Actrapid)后胰岛素的吸收显著加快,其降血糖作用也显著增强。分别使用人胰岛素(诺和诺德公司生产的Monotard)和猪胰岛素(Monotard)制剂时,未观察到吸收动力学的差异。设计了一项临床试验,以确定药代动力学差异是否与常规人胰岛素的临床应用相关。在12名接受持续皮下胰岛素输注治疗的I型糖尿病患者中,采用双盲交叉方案测试了人胰岛素和猪胰岛素(Actrapid)的疗效。两种胰岛素均实现了接近正常的血糖水平。日间血糖值和波动、胰岛素需求量、轻度低血糖发作频率以及饮食中的碳水化合物含量基本相同。因此,在正常人体药代动力学研究中观察到的皮下注射部位人胰岛素与猪常规胰岛素吸收之间的差异,在I型糖尿病接近正常血糖水平的皮下胰岛素替代治疗临床实践中似乎并不相关。