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治疗性随机对照试验中急性呼吸窘迫综合征的迅速改善。

Rapidly Improving ARDS in Therapeutic Randomized Controlled Trials.

机构信息

Department of Medicine, Division of Pulmonary and Critical Care Medicine, New York-Presbyterian Hospital-Weill Cornell Medical Center, Weill Cornell Medicine, New York, NY.

Department of Healthcare Policy and Research, Division of Biostatistics and Epidemiology, Weill Cornell Medicine, New York, NY.

出版信息

Chest. 2019 Mar;155(3):474-482. doi: 10.1016/j.chest.2018.09.031. Epub 2018 Oct 22.

DOI:10.1016/j.chest.2018.09.031
PMID:30359616
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6414787/
Abstract

BACKGROUND

Observational studies suggest that some patients meeting criteria for ARDS no longer fulfill the oxygenation criterion early in the course of their illness. This subphenotype of rapidly improving ARDS has not been well characterized. We attempted to assess the prevalence, characteristics, and outcomes of rapidly improving ARDS and to identify which variables are useful to predict it.

METHODS

A secondary analysis was performed of patient level data from six ARDS Network randomized controlled trials. We defined rapidly improving ARDS, contrasted with ARDS > 1 day, as extubation or a Pao to Fio ratio (Pao:Fio) > 300 on the first study day following enrollment.

RESULTS

The prevalence of rapidly improving ARDS was 10.5% (458 of 4,361 patients) and increased over time. Of the 1,909 patients enrolled in the three most recently published trials, 197 (10.3%) were extubated on the first study day, and 265 (13.9%) in total had rapidly improving ARDS. Patients with rapidly improving ARDS had lower baseline severity of illness and lower 60-day mortality (10.2% vs 26.3%; P < .0001) than ARDS > 1 day. Pao:Fio at screening, change in Pao:Fio from screening to enrollment, use of vasopressor agents, Fio at enrollment, and serum bilirubin levels were useful predictive variables.

CONCLUSIONS

Rapidly improving ARDS, mostly defined by early extubation, is an increasingly prevalent and distinct subphenotype, associated with better outcomes than ARDS > 1 day. Enrollment of patients with rapidly improving ARDS may negatively affect the prognostic enrichment and contribute to the failure of therapeutic trials.

摘要

背景

观察性研究表明,一些符合 ARDS 标准的患者在疾病早期不再满足氧合标准。这种 ARDS 迅速改善的亚表型尚未得到很好的描述。我们试图评估迅速改善的 ARDS 的患病率、特征和结局,并确定哪些变量可用于预测其发生。

方法

对 6 项 ARDS 网络随机对照试验的患者水平数据进行二次分析。我们将迅速改善的 ARDS 定义为与 ARDS > 1 天相比,在入组后的第一个研究日拔管或 PaO2/Fio2 比(Pao:Fio)> 300。

结果

迅速改善的 ARDS 患病率为 10.5%(4361 例患者中有 458 例),且呈上升趋势。在最近发表的三项试验中,1909 例入组患者中,有 197 例(10.3%)在第一个研究日拔管,共有 265 例(13.9%)患者出现迅速改善的 ARDS。与 ARDS > 1 天相比,迅速改善的 ARDS 患者的基线疾病严重程度更低,60 天死亡率更低(10.2%比 26.3%;P <.0001)。筛选时的 Pao:Fio、从筛选到入组的 Pao:Fio 变化、血管加压药的使用、入组时的 Fio 和血清胆红素水平是有用的预测变量。

结论

迅速改善的 ARDS,主要通过早期拔管来定义,是一种越来越普遍且独特的亚表型,与 ARDS > 1 天相比,其结局更好。迅速改善的 ARDS 患者的入组可能会对预后富集产生负面影响,并导致治疗试验失败。

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