Heinemann L
Department of Metabolic Diseases and Nutrition, WHO Collaborating Center for Diabetes, Heinrich-Heine University, Düsseldorf, Germany.
J Diabetes Complications. 1999 Mar-Apr;13(2):105-14. doi: 10.1016/s1056-8727(99)00031-8.
Rapid-acting insulin analogues were developed in answer to the need for a more appropriate time-action profile for prandial insulin substitution therapy. Improvements in at least one of three important endpoints needs to be demonstrated-metabolic control, hypoglycemic events, and/or quality of life-if there is to be a case for use of a new insulin preparation. This paper considers the data available on hypoglycemic events in the 24 controlled clinical trials (19 open, unblinded, and 5 double-blind) reported to date with rapid-acting insulin analogues (22 studies with insulin lispro). A significant reduction in the incidence of mild hypoglycemia was observed in 5 of 22 studies (22%). No change in frequency of severe hypoglycemic episodes was observed 10 of 12 studies (83%) reporting such events. A decrease in the frequency of nocturnal hypoglycemia has been reported in six studies; however, in the other 18 studies, no similar decrease in numbers were reported. There is no evidence for a reduction in patient awareness of hypoglycemia with rapid-acting insulin analogues. Even a slight reduction in hypoglycemic events would be welcomed by diabetic patients. However, rapid-acting insulins are only appropriate for use in patients using an intensive insulin regimen. Such patients are well motivated and well educated and will be able to adapt their insulin therapy to take account of the changes in the time-action profile of the rapid-acting insulin analogues. Thus, rapid-acting insulin analogues do not appear to have revolutionized insulin therapy, but appropriate use should result in benefits such as improved metabolic control for diabetic patients.
速效胰岛素类似物的研发是为了满足餐时胰岛素替代治疗对更合适的时间-作用曲线的需求。如果要证明一种新胰岛素制剂的使用合理性，就需要在三个重要终点中的至少一个方面有所改善，即代谢控制、低血糖事件和/或生活质量。本文考虑了迄今为止报道的24项对照临床试验（19项开放、非盲法和5项双盲试验）中有关速效胰岛素类似物（22项使用赖脯胰岛素的研究）低血糖事件的可用数据。在22项研究中的5项（22%）观察到轻度低血糖发生率显著降低。在报告此类事件的12项研究中的10项（83%）未观察到严重低血糖发作频率的变化。六项研究报告夜间低血糖频率有所降低；然而，在其他18项研究中，未报告类似的数量减少情况。没有证据表明速效胰岛素类似物能降低患者对低血糖的感知。即使低血糖事件略有减少，糖尿病患者也会欢迎。然而，速效胰岛素仅适用于采用强化胰岛素治疗方案的患者。这类患者积极性高且教育程度良好，能够调整胰岛素治疗方案以考虑速效胰岛素类似物时间-作用曲线的变化。因此，速效胰岛素类似物似乎并未彻底改变胰岛素治疗，但合理使用应能为糖尿病患者带来如改善代谢控制等益处。
