Bruni Bocher K, Giolitti A, Turco G L, Benedetto P, Bruni B
Minerva Med. 1975 Mar 14;66(19):909-30.
The immunogenicity of conventional therapeutical insulin is discussed according to the concepts of Schlichtkrull: the formation of insulin antibodies is not attributable to the pure Sanger's insulin molecule, but to related protein impurities, present in all crystallized pig and ox insulin preparations. The terms of monocomponent insulin, highly purified insulin, and single peak insulin in defined and personal clinical results obtained with Novo Monocomponent Lente Insulin over a period of 3 years are presented. The Hein Christiansen's radioimmunoelectrophoretic method fo estimation of 125I-insulin IgG binding was used to determine insulin antibody levels. It was found that: 1) Newly detected insulin-dependent diabetics, never previously treated with insulin, do not produce insulin antibodies at a significant level; 2) Long-term insulin treated diabetics, transferred to monocomponent treatment, tend to reduce their antibody levels, if initially high, altough with transient recurrent peaks; 3) Stimulation of the immunocompetent system by intercurrent infection does not generally modify the immunological situation. Apart from immunological changes, satisfactory clinical results were observed in cases of high insulin requirement, insulin allergy, insulin lipoatrophy. Present practical indications for monocomponent insulin therapy (Actrapid-Lenta) are proposed.
根据施利希特克鲁尔的观点,讨论了传统治疗性胰岛素的免疫原性:胰岛素抗体的形成并非归因于纯桑格胰岛素分子,而是归因于所有结晶猪胰岛素和牛胰岛素制剂中存在的相关蛋白质杂质。介绍了使用诺和单组分低精蛋白胰岛素在3年期间获得的明确和个人临床结果中关于单组分胰岛素、高纯度胰岛素和单峰胰岛素的术语。采用海因·克里斯蒂安森的放射免疫电泳法测定125I胰岛素IgG结合,以确定胰岛素抗体水平。结果发现:1)新诊断的胰岛素依赖型糖尿病患者,以前从未接受过胰岛素治疗,不会产生显著水平的胰岛素抗体;2)长期接受胰岛素治疗的糖尿病患者,转为单组分胰岛素治疗后,如果最初抗体水平较高,其抗体水平往往会降低,尽管会出现短暂的复发高峰;3)并发感染对免疫活性系统的刺激通常不会改变免疫状况。除免疫变化外,在胰岛素需求量高、胰岛素过敏、胰岛素性脂肪萎缩的病例中也观察到了满意的临床效果。提出了单组分胰岛素治疗(诺和灵R-诺和灵N)的当前实际应用指征。