Michael Kreuter, Joyce S Lee, A. Tzouvelekis, J. Oldham, P. Molyneaux, Derek Weycker, M. Atwood, Katerina Samara, K. Kirchgässler, Toby M Maher
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引用次数: 0
Abstract
The Gender, Age and Physiology (GAP) model is a simple mortality prediction tool in patients with idiopathic pulmonary fibrosis (IPF) using demographic and physiological variables available at initial evaluation. White blood cell (WBC) variables may have associations with IPF outcomes. We evaluated whether incorporation of blood cell counts in modified GAP (cGAP) models would improve outcome prediction in patients with IPF.This retrospective analysis included pooled data from randomised Phase III trials of pirfenidone in IPF (ASCEND, CAPACITY 004, CAPACITY 006). Study outcomes (IPF progression, all-cause mortality, all-cause hospitalisation, respiratory-related hospitalisation) were evaluated during the initial 1-year period. Shared frailty models were used to evaluate associations between continuous and categorical baseline WBC and red blood cell (RBC) parameters and study outcomes in a bivariate context; and the impact of adding continuous monocyte count (cGAP1) or WBC and RBC parameters (cGAP2) to traditional GAP variables in a multivariable context based on C-statistics changes.Data were pooled from 1247 patients (pirfenidone, n=623; placebo, n=624). Significant associations (bivariate analyses) were: IPF progression with neutrophil and eosinophil counts; all-cause mortality with monocyte and neutrophil counts; all-cause hospitalisation with monocyte count, neutrophil count and haemoglobin level; and respiratory-related hospitalisation with monocyte count, neutrophil count and haemoglobin level. In multivariate analyses, C-statistics were highest for the cGAP2 model for each of the outcomes.Modified GAP models incorporating monocyte counts alone or plus other WBC and RBC variables may be useful to improve prediction of outcomes in patients with IPF.ClinicalTrials.gov identifiersNCT01366209;NCT00287716;NCT00287729.
性别、年龄和生理(GAP)模型是一种简单的特发性肺纤维化(IPF)患者死亡率预测工具,它使用了初步评估时可获得的人口和生理变量。白细胞(WBC)变量可能与 IPF 的预后有关。我们评估了将血细胞计数纳入改良 GAP(cGAP)模型是否会改善 IPF 患者的预后预测。这项回顾性分析包括 IPF 吡非尼酮随机 III 期试验(ASCEND、CAPACITY 004、CAPACITY 006)的汇总数据。研究结果(IPF进展、全因死亡率、全因住院、呼吸相关住院)在最初的1年期间进行了评估。共享虚弱模型用于评估连续和分类基线白细胞和红细胞 (RBC) 参数与双变量研究结果之间的关联;以及在多变量情况下,根据 C 统计量变化将连续单核细胞计数(cGAP1)或白细胞和红细胞参数(cGAP2)添加到传统 GAP 变量的影响。显著相关性(双变量分析)为IPF进展与中性粒细胞和嗜酸性粒细胞计数有关;全因死亡率与单核细胞和中性粒细胞计数有关;全因住院与单核细胞计数、中性粒细胞计数和血红蛋白水平有关;呼吸相关住院与单核细胞计数、中性粒细胞计数和血红蛋白水平有关。在多变量分析中,cGAP2 模型对每种结果的 C 统计量都是最高的。仅纳入单核细胞计数或加上其他白细胞和红细胞变量的改良 GAP 模型可能有助于改善对 IPF 患者结果的预测。
期刊介绍:
ERJ Open Research is a fully open access original research journal, published online by the European Respiratory Society. The journal aims to publish high-quality work in all fields of respiratory science and medicine, covering basic science, clinical translational science and clinical medicine. The journal was created to help fulfil the ERS objective to disseminate scientific and educational material to its members and to the medical community, but also to provide researchers with an affordable open access specialty journal in which to publish their work.