Lefebvre Patrick, Vekeman Francis, Sarokhan Brenda, Enny Christopher, Provenzano Robert, Cremieux Pierre-Yves
Groupe d'analyse, Ltée, Montréal, Québec, Canada.
Curr Med Res Opin. 2006 Oct;22(10):1929-37. doi: 10.1185/030079906X132541.
To evaluate the relationship between hemoglobin (Hb) level and quality of life (QOL) in anemic patients with non-dialysis chronic kidney disease receiving epoetin alfa.
A post-hoc analysis using data from a multicenter, open-label, prospective study of epoetin alfa for anemia in patients with chronic kidney disease not on dialysis was conducted. The relationship between Hb and QOL was analyzed using correlation and longitudinal analyses, the latter adjusting for sample selection bias. The Linear Analog Scale Assessment (LASA) and the Kidney Disease Questionnaire (KDQ) subscales were used to measure QOL. The impact of an incremental 1 g/dL increase in Hb level on LASA and KDQ scores was determined using an incremental analysis.
A total of 1183 and 1044 patients formed the study populations for the LASA and KDQ analyses, respectively. There was a positive and significant relationship between Hb levels and QOL (p < 0.05). Using non-linear regression analysis, we characterized the sigmoid-shape of the relationship between Hb levels and QOL scores. Hemoglobin change was a statistically significant determinant of QOL improvement for both LASA and KDQ scales (p < 0.05). The model predicted that, based on a 2 unit change in Hb, the greatest incremental QOL improvement per unit of Hb increase occurred when Hb was in the range of 11 to 12 g/dL.
This study demonstrates that, beyond the well-known relationship between Hb increases and QOL improvements, the maximal incremental gain in QOL occurred when Hb reached 11 to 12 g/dL. This suggests that treating anemic patients with non-dialysis chronic kidney disease until their Hb level reaches 12 g/dL will result in the greatest QOL improvement per Hb unit increase. The analyses were conducted based on an open-label study of epoetin alfa and could be further validated using a randomized, controlled trial, comparing incremental gains in QOL associated with treatment initiation at varying levels of Hb across arms.
评估接受促红细胞生成素α治疗的非透析慢性肾脏病贫血患者血红蛋白（Hb）水平与生活质量（QOL）之间的关系。
采用来自一项多中心、开放标签、前瞻性研究的数据进行事后分析，该研究旨在探讨促红细胞生成素α对未接受透析的慢性肾脏病患者贫血的治疗效果。使用相关性分析和纵向分析来分析Hb与QOL之间的关系，后者对样本选择偏倚进行了校正。采用线性模拟量表评估（LASA）和肾脏病问卷（KDQ）子量表来测量QOL。使用增量分析确定Hb水平每增加1 g/dL对LASA和KDQ评分的影响。
分别有1183例和1044例患者构成了LASA分析和KDQ分析的研究人群。Hb水平与QOL之间存在正相关且具有统计学意义（p < 0.05）。通过非线性回归分析，我们描绘了Hb水平与QOL评分之间呈S形关系的特征。Hb变化是LASA和KDQ量表QOL改善的统计学显著决定因素（p < 0.05）。该模型预测，基于Hb的2个单位变化，当Hb在11至12 g/dL范围内时，每单位Hb增加所带来的QOL改善增量最大。
本研究表明，除了Hb升高与QOL改善之间的已知关系外，当Hb达到11至12 g/dL时，QOL的最大增量收益出现。这表明，将非透析慢性肾脏病贫血患者的Hb水平治疗至12 g/dL，每增加一个单位的Hb将带来最大的QOL改善。这些分析是基于一项促红细胞生成素α的开放标签研究进行的，可通过随机对照试验进一步验证，比较不同Hb水平起始治疗的各治疗组之间QOL的增量收益。
