Prescribing Research Group, University of Liverpool, Liverpool, UK.
Clin Drug Investig. 2004;24(12):695-717. doi: 10.2165/00044011-200424120-00002.
This paper provides a review and evaluation of the published evidence relating to the efficacy, safety and ease of administration of the rapid-acting insulin analogue insulin aspart in comparison with human insulin (HI) in diabetes mellitus in the following categories: (a) in adults, (b) in children, and (c) in continuous subcutaneous insulin infusion (CSII). A search for publications on insulin aspart was conducted for the following databases: Cochrane, BIOSIS, EMBASE-DP and MEDLINE. Publications were examined for relevance by two independent assessors and were graded using a system developed by the Oxford Centre for Evidence-Based Medicine. Overall, the evidence comparing insulin aspart with HI was of high quality, with all three categories graded as grade A evidence. Studies showed strong evidence for better glycaemic control, without an increased risk of hypoglycaemia, together with evidence supporting improved convenience and flexibility in administration of insulin aspart compared with regular HI in adult diabetic patients. Evidence from three trials in adults with type 1 diabetes showed a lower incidence of major nocturnal hypoglycaemia with insulin aspart versus regular HI. Published evidence also confirmed the more rapid action of insulin aspart versus HI, and a comparable efficacy and safety profile for both insulin types in type 1 paediatric patients. There was also strong evidence that insulin aspart is well tolerated and efficacious for CSII/pump use. Insulin aspart better mimics the physiological response to meals than regular HI, and may offer advantages in terms of glycaemic control and reduction of hypoglycaemia combined with flexibility and convenience of administration. Overall, there is a good body of evidence to support the efficacy, tolerability and ease of administration of insulin aspart in patients with type 1 and type 2 diabetes.
本文综述和评估了已发表的证据，涉及速效胰岛素类似物门冬胰岛素与人类胰岛素（HI）相比在以下几类糖尿病患者中的疗效、安全性和给药方便性：（a）成人，（b）儿童，和（c）持续皮下胰岛素输注（CSII）。在以下数据库中搜索了有关门冬胰岛素的出版物：考科兰、BIOSIS、EMBASE-DP 和 MEDLINE。两名独立评估员对出版物进行了相关性检查，并使用牛津循证医学中心开发的系统进行了分级。总的来说，比较门冬胰岛素与 HI 的证据质量很高，所有三个类别均为 A 级证据。研究表明，门冬胰岛素在控制血糖方面具有更强的疗效，且低血糖风险无增加，同时在给药方便性和灵活性方面也优于常规 HI，这些证据支持成年糖尿病患者使用门冬胰岛素。三项 1 型糖尿病成人患者的试验提供了强有力的证据，表明与常规 HI 相比，门冬胰岛素的夜间低血糖发生率更低。已发表的证据还证实了门冬胰岛素与 HI 相比具有更快的作用，并且在 1 型儿科患者中两种胰岛素的疗效和安全性相似。也有强有力的证据表明，门冬胰岛素在 CSII/泵治疗中具有良好的耐受性和疗效。与常规 HI 相比，门冬胰岛素更能模拟进餐时的生理反应，在控制血糖和减少低血糖的同时，具有更好的灵活性和给药方便性。总体而言，有大量证据支持门冬胰岛素在 1 型和 2 型糖尿病患者中的疗效、耐受性和给药方便性。
