The stroke oxygen pilot study: a randomized controlled trial of the effects of routine oxygen supplementation early after acute stroke--effect on key outcomes at six months.
The stroke oxygen pilot study: a randomized controlled trial of the effects of routine oxygen supplementation early after acute stroke--effect on key outcomes at six months.
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DOI：
10.1371/journal.pone.0059274
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发表时间：
2014
期刊：
影响因子：
3.7
通讯作者：
Roffe C
中科院分区：
文献类型：
--
作者：
Ali K;Warusevitane A;Lally F;Sim J;Sills S;Pountain S;Nevatte T;Allen M;Roffe C
卒中后缺氧很常见，可能会对预后产生不利影响。我们最近的研究表明，氧气补充可以改善早期神经功能恢复。在这里，我们报告了这项试点研究的六个月结果。将临床诊断为急性卒中的患者随机分为两组，一组在入院后24小时内以2或3 L/分钟的速度补充氧气，持续72小时；另一组为对照组(室内空气)。结果(见下文)在6个月时通过邮寄问卷进行评估。按意向处理进行分析，统计学意义设为p≤0.05。在301例患者中，随机抽取2例拒绝/撤回同意，289例(氧气组148例，对照组141例)进入分析：男性44%，51%；平均年龄73(12)岁，71(12)岁；美国国立卫生研究院卒中评分中位数(IQR)6(3，10)分，5(3，10)分。在6个月时，氧气组有22例(15%)患者死亡，对照组有20例(14%)死亡；两组患者的平均存活时间均为162d(p = 0.99)。氧气组和对照组的主要结果的中位数(IQR)评分分别为3(1，5)分和3(1，4)分。协变量调整后的优势比为1.0 4(95%CI 0.6 7，1.6 0)，表明氧气组得分较低(即较好)的优势比无显著差异(p = 0.86)。在日常生活的基本能力(Barthel指数)和扩展活动能力(NEADL)以及生活质量(EuroQol)方面的平均差异也不显著。在6个月时，两组之间的关键结果都没有不同。尽管这些影响在统计学上并不显著，而且通常幅度不大，但主要有利于氧气组；一项旨在显示长期功能结果差异的更大规模的试验目前正在进行中。受控试验网站ISRCTN12362720；Eudract.ema.Europa.eu 2004-001866-41
Post-stroke hypoxia is common, and may adversely affect outcome. We have recently shown that oxygen supplementation may improve early neurological recovery. Here, we report the six-month outcomes of this pilot study. Patients with a clinical diagnosis of acute stroke were randomized within 24 h of admission to oxygen supplementation at 2 or 3 L/min for 72 h or to control treatment (room air). Outcomes (see below) were assessed by postal questionnaire at 6 months. Analysis was by intention-to-treat, and statistical significance was set at p≤0.05. Out of 301 patients randomized two refused/withdrew consent and 289 (148 in the oxygen and 141 in the control group) were included in the analysis: males 44%, 51%; mean (SD) age 73 (12), 71 (12); median (IQR) National Institutes of Health Stroke Scale score 6 (3, 10), 5 (3, 10) for the two groups respectively. At six months 22 (15%) patients in the oxygen group and 20 (14%) in the control group had died; mean survival in both groups was 162 days (p = 0.99). Median (IQR) scores for the primary outcome, the modified Rankin Scale, were 3 (1, 5) and 3 (1, 4) for the oxygen and control groups respectively. The covariate-adjusted odds ratio was 1.04 (95% CI 0.67, 1.60), indicating that the odds of a lower (i.e. better) score were non-significantly higher in the oxygen group (p = 0.86). The mean differences in the ability to perform basic (Barthel Index) and extended activities of daily living (NEADL), and quality of life (EuroQol) were also non-significant. None of the key outcomes differed at 6 months between the groups. Although not statistically significant and generally of small magnitude, the effects were predominantly in favour of the oxygen group; a larger trial, powered to show differences in longer-term functional outcomes, is now on-going. Controlled-Trials.com ISRCTN12362720; Eudract.ema.europa.eu 2004-001866-41
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