Department of Human Metabolism, School of Medicine and Biosciences, University of Sheffield, Sheffield, UK.
Diabetes Metab Res Rev. 2012 Jan;28(1):50-61. doi: 10.1002/dmrr.1240.
Diabetes management is changing not only with novel treatments but also in patient demography. This presents clinical challenges and influences our view of diabetes therapies. Insulin analogues have been developed to overcome some of the limitations of traditional human insulins, with the aim of providing a more physiological pharmacokinetic/pharmacodynamic profile. The rapid-acting insulin analogue insulin aspart has been investigated in many clinical trials over the past 10 years and the aim of this review is to present the insulin aspart clinical trial data from across the spectrum of patients with diabetes. Five studies have looked at insulin aspart use (including continuous subcutaneous insulin infusion) in children and adolescents, where the analogue was as effective and well tolerated as soluble human insulin. One large-scale, randomized, controlled trial in pregnant women with type 1 diabetes observed trends towards a reduction in major hypoglycaemia, fewer preterm deliveries and lower birthweight with insulin aspart compared with soluble human insulin. Two 6-month, randomized, controlled, multicentre, multinational, parallel-group, open-label trials reported significant reductions in haemoglobin A(1c) and major nocturnal hypoglycaemia with insulin aspart compared with soluble human insulins in patients with type 1 diabetes. There are fewer data involving insulin analogue use in hospitals and in elderly patients with diabetes, but some recent studies have investigated insulin aspart in the emergency department, intensive/non-intensive care setting and in a pharmacokinetic/pharmacodynamic study in patients aged ≥ 65 years. In summary, the evidence would suggest that insulin aspart is suitable for use in a variety of patients with diabetes.
糖尿病的管理不仅在新的治疗方法上发生了变化,而且在患者人群上也发生了变化。这给临床带来了挑战,并影响了我们对糖尿病治疗方法的看法。胰岛素类似物的开发是为了克服传统人胰岛素的一些局限性,目的是提供更生理性的药代动力学/药效学特征。速效胰岛素类似物门冬胰岛素在过去 10 年的许多临床试验中得到了研究,本综述的目的是介绍门冬胰岛素在各种糖尿病患者中的临床试验数据。有五项研究观察了门冬胰岛素(包括持续皮下胰岛素输注)在儿童和青少年中的应用,结果表明该类似物与可溶性人胰岛素一样有效且耐受性良好。一项针对 1 型糖尿病孕妇的大规模、随机、对照、多中心、多国、平行组、开放性临床试验观察到,与可溶性人胰岛素相比,门冬胰岛素可降低主要低血糖事件的发生率、减少早产和降低出生体重的趋势。两项为期 6 个月的随机、对照、多中心、多国、平行组、开放性临床试验报告称,与可溶性人胰岛素相比,1 型糖尿病患者使用门冬胰岛素可显著降低糖化血红蛋白(HbA1c)和主要夜间低血糖事件的发生率。在医院和老年糖尿病患者中,关于胰岛素类似物使用的数据较少,但最近的一些研究调查了门冬胰岛素在急诊科、重症/非重症监护病房以及在≥65 岁患者的药代动力学/药效学研究中的应用。总之,证据表明门冬胰岛素适合各种糖尿病患者使用。