门冬胰岛素30可改善2型糖尿病患者的生活质量

Improvements in quality of life associated with biphasic insulin aspart 30 in people with type 2 diabetes in China

目的：评估2型糖尿病患者起始或改用门冬胰岛素30治疗后健康相关生活质量（HRQoL）的变化。方法2008年11月至2011年3月，在全国130家研究中心招募起始或改用门冬胰岛素30、地特胰岛素或门冬胰岛素治疗的患者，观察24周的治疗效果，并在基线和24周时采用欧洲五维健康量表（EQ-5D）对患者的HRQoL进行评估。本文报告起始或改用门冬胰岛素30的中国2型糖尿病患者在基线和24周时HRQoL的变化，并进一步分析由口服降糖药转为门冬胰岛素30和由预混人胰岛素转为门冬胰岛素30的亚组人群信息。采用配对t检验、卡方检验等进行统计学分析。结果共纳入8578例中国患者接受门冬胰岛素30治疗。24周后，总体研究人群、由口服降糖药转为门冬胰岛素30组、由预混人胰岛素转为门冬胰岛素30组人群的EQ-5D VAS评分分别增加6分（76至82）、6分（76至82）和7分（75至82），健康效用值分别增加0.018（0.875至0.893）、0.019（0.876至0.894）和0.034（0.845至0.879），前后差异均有统计学意义（t=28.10、19.80、10.90、5.90、4.30、3.90，均P〈0.05）。EQ-5D量表的多个维度报告没有问题的患者比例均有所增加。结论血糖控制不佳的中国2型糖尿病患者起始或转用门冬胰岛素30治疗后生活质量显著改善。

Objective To evaluate the changes of health-related quality of life （HRQoL） in Chinese patients with type 2 diabetes （T2DM） after starting with, or switching to, biphasic insulin aspart 30 （BIAsp 30）. Methods From November 2008 to March 2011, eligible T2DM patients, initiating or switching to premix （BIAsp 30）, basal （insulin detemir）, and meal-time （insulin aspart） insulin analogs, were recruited from 130 hospitals in China. HRQoL was evaluated by European Quality of Life-5 Dimensions （EQ-5D） questionnaire at baseline and 24 weeks. This study reported how HRQoL changed in Chinese people with T2DM after starting with, or switching to, BIAsp 30. Subgroup analyses were conducted. The paired t test, and Chi-square test were conducted for statistical analysis. Results The reported HRQoL measured by EQ-5D visual analogue scale score in total cohort, subgroup switching from oral anti-diabetic drugs （OADs） and subgroup switching from human premix insulin increased by 6.2 （from 75.8 to 82.0）, 5.9（from 75.7 to 81.6） and 6.6（from 75.0 to 81.6） respectively;and the EQ-5D index score over 24 weeks increased by 0.018 （from 0.875 to 0.893）, 0.019（from 0.876 to 0.894） and 0.034（from 0.845 to 0.879）, respectively; all the changes were statically significant （t=28.10, 19.80, 10.90, 5.90, 4.30, 3.90, all P〈0.05）. The percentage of patients reporting no problems in the mobility, pain/discomfort, and anxiety/depression dimensions of EQ-5D increased to some extent too. Conclusion BIAsp 30 treatment is associated with improved HRQoL in patients with T2DM in China.