Department of Geriatrics and Metabolic Diseases, Second University of Naples, Piazza L. Miraglia, 80138 Naples, Italy.
Diabetes Res Clin Pract. 2011 Apr;92(1):1-10. doi: 10.1016/j.diabres.2010.08.006. Epub 2010 Sep 6.
We conducted a systematic review of randomized controlled trials that evaluated the effectiveness of insulin regimens (basal, biphasic, prandial, and basal-bolus) with insulin analogues to reach the haemoglobin A1c target of <7% in patients with type 2 diabetes. We identified 48 trials, with 85 arms and 30,588 patients. There were 38 arms using basal insulin, with 17,588 patients, and a primary outcome of 41.4% (95% CI=35.6-47.4%); 26 arms using biphasic insulin, with 9237 patients, and a primary outcome of 46.5% (40.8-52.3%); 9 arms using prandial insulin, with 1605 patients, and a primary outcome of 39.6% (95% CI, 28.6-51.3%); and 12 arms using basal-bolus insulin, with 2114 patients, and a primary outcome of 53.9% (43.5-64). The high heterogeneity was related, in part, to first time insulin use, final insulin dose, and use of oral drug. The overall incidence of hypoglycaemia ranged from 0 to 4.71 events/patient/30 days; weight gain ranged from 1.75 kg for basal to 3 kg for biphasic insulin. The HbA1c target of <7% can be achieved in a percentage of type 2 diabetic patients ranging from 40% to 54% depending on the particular insulin regimen.
我们对评估了不同胰岛素方案(基础、双相、餐时和基础-餐时)联合胰岛素类似物治疗 2 型糖尿病患者,使糖化血红蛋白(HbA1c)目标值<7%的随机对照试验进行了系统评价。我们共纳入 48 项试验,85 个治疗组,涉及 30588 例患者。其中,38 个治疗组使用基础胰岛素,涉及 17588 例患者,主要结局为 41.4%(95%可信区间为 35.6%-47.4%);26 个治疗组使用双相胰岛素,涉及 9237 例患者,主要结局为 46.5%(40.8%-52.3%);9 个治疗组使用餐时胰岛素,涉及 1605 例患者,主要结局为 39.6%(95%可信区间为 28.6%-51.3%);12 个治疗组使用基础-餐时胰岛素,涉及 2114 例患者,主要结局为 53.9%(43.5%-64.0%)。高异质性部分与首次使用胰岛素、最终胰岛素剂量和口服药物的使用有关。低血糖总体发生率为 0-4.71 事件/患者/30 天;体重增加从基础胰岛素的 1.75kg 到双相胰岛素的 3kg。不同胰岛素方案可使 2 型糖尿病患者的 HbA1c 目标值<7%的比例为 40%-54%。