BHF Centre for Cardiovascular Science, The Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK.
Diabetes Obes Metab. 2013 Nov;15(11):978-86. doi: 10.1111/dom.12106. Epub 2013 May 1.
The aim of this review is to summarize the clinical efficacy, tolerability and safety data of insulin detemir, and compare its use with that of neutral protamine Hagedorn (NPH) insulin in randomized controlled trials in people with type 1 or type 2 diabetes. A literature search was conducted with PubMed using predefined search terms. Studies were included if they met the following criteria: randomized, controlled trial, comparison of insulin detemir with NPH insulin, non-hospitalized adults aged ≥18 years with either type 1 or type 2 diabetes, and study duration of ≥12 weeks. The following types of studies were excluded: non-randomized controlled trials, studies of mixed cohorts of patients with type 1 or type 2 diabetes that did not report results separately, pharmacokinetic/pharmacodynamic studies, reviews, pooled or meta-analyses or health-economic analyses. Fourteen publications met the inclusion criteria. Nine studies in people with type 1 diabetes and three studies in people with type 2 diabetes, using insulin detemir in a basal-bolus regimen were included. Two studies were in people with type 2 diabetes using insulin detemir with oral antidiabetes medicines. In 14 studies of people with type 1 or type 2 diabetes, insulin detemir treatment provided similar or better glycaemic control, lower within-subject variability, similar or lower frequency of hypoglycaemia and less weight gain when compared with NPH insulin.
这篇综述的目的是总结地特胰岛素的临床疗效、耐受性和安全性数据，并将其在 1 型或 2 型糖尿病患者中的随机对照试验与中性鱼精蛋白锌胰岛素（NPH）的使用进行比较。使用预定义的搜索词在 PubMed 上进行了文献检索。如果符合以下标准，则纳入研究：随机对照试验、地特胰岛素与 NPH 胰岛素的比较、非住院的年龄≥18 岁的 1 型或 2 型糖尿病患者、研究持续时间≥12 周。排除以下类型的研究：非随机对照试验、未分别报告 1 型或 2 型糖尿病混合队列患者结果的研究、药代动力学/药效学研究、综述、汇总或荟萃分析或健康经济学分析。有 14 篇出版物符合纳入标准。纳入了 9 项 1 型糖尿病患者和 3 项 2 型糖尿病患者的研究，这些患者使用地特胰岛素进行基础-餐时胰岛素方案治疗。有 2 项研究涉及使用口服抗糖尿病药物的 2 型糖尿病患者。在 14 项 1 型或 2 型糖尿病患者的研究中，与 NPH 胰岛素相比，地特胰岛素治疗提供了相似或更好的血糖控制、更低的个体内变异性、相似或更低的低血糖发生率和更少的体重增加。
