Ashwell Simon G, Bradley Clare, Stephens James W, Witthaus Elke, Home Philip D
Newcastle University, Newcastle upon Tyne, UK.
Diabetes Care. 2008 Jun;31(6):1112-7. doi: 10.2337/dc07-1183. Epub 2008 Mar 13.
The purpose of this study was to compare quality of life (QoL) and treatment satisfaction using insulin glargine plus insulin lispro with that using NPH insulin plus unmodified human insulin in adults with type 1 diabetes managed with multiple injection regimens.
As part of a 32-week, five-center, two-way crossover study in 56 individuals with type 1 diabetes randomized to evening insulin glargine plus mealtime insulin lispro or to NPH insulin (once or twice daily) plus mealtime unmodified human insulin, the Diabetes Treatment Satisfaction Questionnaire (DTSQ) and the Audit of Diabetes Dependent Quality of Life questionnaire were completed at baseline and at weeks 16 and 32, with additional interim DTSQ measurements.
For all patients combined, the mean baseline present QoL score was 1.3, reflecting "good" QoL. Present QoL improved with glargine + lispro but did not change with NPH + human insulin (1.6 +/- 0.1 [mean +/- SEM] vs. 1.3 +/- 0.1, difference 0.3 [95% CI 0.1-0.6]; P = 0.014). Baseline mean average weighted impact score (AWI) of diabetes on QoL was -1.8, indicating a negative impact of diabetes on QoL. The AWI score at end point improved significantly with glargine + lispro but changed little with NPH + human insulin (-1.4 +/- 0.1 vs. -1.7 +/- 0.1, 0.3 [0.0-0.6]; P = 0.033). Treatment satisfaction (DTSQ 36-0 scale score) at end point was markedly greater with glargine plus lispro compared with that for NPH plus human insulin (32.2 +/- 3.4 vs. 23.9 +/- 7.2, 8.6 [6.5-10.6]; P < 0.001).
Insulin glargine plus insulin lispro improves treatment satisfaction, reduces the negative impact of diabetes on QoL, and improves QoL in comparison with NPH insulin plus unmodified human insulin in type 1 diabetes.
本研究旨在比较在采用多次注射方案治疗的1型糖尿病成年患者中，甘精胰岛素联合赖脯胰岛素与中性鱼精蛋白锌胰岛素（NPH）联合普通胰岛素的生活质量（QoL）及治疗满意度。
作为一项为期32周、五中心、双向交叉研究的一部分，56例1型糖尿病患者被随机分为两组，分别接受睡前甘精胰岛素联合餐时赖脯胰岛素治疗，或NPH胰岛素（每日1次或2次）联合餐时普通胰岛素治疗。在基线、第16周和第32周完成糖尿病治疗满意度问卷（DTSQ）和糖尿病相关生活质量调查问卷，期间还进行了额外的DTSQ测量。
所有患者的平均基线当前生活质量评分为1.3，表明生活质量“良好”。甘精胰岛素联合赖脯胰岛素治疗使当前生活质量得到改善，但NPH胰岛素联合普通胰岛素治疗未使其发生变化（1.6±0.1[均值±标准误]对1.3±0.1，差值0.3[95%置信区间0.1 - 0.6]；P = 0.014）。糖尿病对生活质量的基线平均加权影响评分（AWI）为 - 1.8，表明糖尿病对生活质量有负面影响。甘精胰岛素联合赖脯胰岛素治疗使终点时的AWI评分显著改善，但NPH胰岛素联合普通胰岛素治疗使其变化不大（-1.4±0.1对-1.7±0.1，0.3[0.0 - 0.6]；P = 0.033）。与NPH胰岛素联合普通胰岛素治疗相比，甘精胰岛素联合赖脯胰岛素治疗在终点时的治疗满意度（DTSQ 36 - 0量表评分）显著更高（32.2±3.4对23.9±7.2，8.6[6.5 - 10.6]；P < 0.001）。
与NPH胰岛素联合普通胰岛素相比，甘精胰岛素联合赖脯胰岛素可提高治疗满意度，降低糖尿病对生活质量的负面影响，并改善1型糖尿病患者的生活质量。
