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高纯度半合成胰岛素与高纯度猪胰岛素治疗Ⅰ型糖尿病的比较:一项多中心随机单盲研究的中期报告

Comparison of highly purified semi-synthetic insulin and highly purified porcine insulin in the treatment of type I diabetes: interim report of a multi-centre randomised single blind study.

作者信息

Birtwell A J, Owens D R, Jones I R, Hayes T M, Beale D J, el-Shaboury A H, Arora P, Reeves W G

出版信息

Diabete Metab. 1984 Dec;10(5):295-8.

PMID:6397365
Abstract

This is an interim report of a long term single-blind study of the effects of changing diabetic patients treated with highly purified porcine insulin to semi-synthetic human insulins of identical formulation. Twenty four insulin dependent diabetics were randomly allocated to continue with porcine insulin (n = 11) or human insulin (n = 13). There were no significant changes within the groups nor differences between the groups in mean preprandial capillary blood glucose, glycosylated haemoglobin or insulin dose during the first 24 weeks of the study. Insulin antibody levels remained low and did not differ between the groups. No local or systemic adverse reactions were observed. In this group of patients conversion to human insulin did not result in a change in diabetic control or insulin dose.

摘要

这是一项长期单盲研究的中期报告,该研究旨在探讨将接受高纯度猪胰岛素治疗的糖尿病患者转换为相同配方的半合成人胰岛素后的效果。24名胰岛素依赖型糖尿病患者被随机分配,继续使用猪胰岛素(n = 11)或人胰岛素(n = 13)。在研究的前24周内,两组患者的餐前毛细血管血糖平均值、糖化血红蛋白或胰岛素剂量均无显著变化,组间也无差异。胰岛素抗体水平维持在较低水平,两组之间无差异。未观察到局部或全身不良反应。在这组患者中,转换为人胰岛素并未导致糖尿病控制情况或胰岛素剂量的改变。

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