中风吸氧初步研究：急性中风后早期常规吸氧效果的随机对照试验——对六个月时关键结局的影响
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.
作者信息
Ali Khalid, Warusevitane Anushka, Lally Frank, Sim Julius, Sills Sheila, Pountain Sarah, Nevatte Tracy, Allen Martin, Roffe Christine
机构信息
Academic Department of Geriatrics, Brighton and Sussex Medical School, Brighton, United Kingdom.
出版信息
PLoS One. 2013 Jun 3;8(6):e59274. doi: 10.1371/journal.pone.0059274. Print 2014.
INTRODUCTION
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.
METHODS
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.
RESULTS
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.
CONCLUSIONS
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.
TRIAL REGISTRATION
Controlled-Trials.com ISRCTN12362720; Eudract.ema.europa.eu 2004-001866-41.
引言
中风后缺氧很常见，可能对预后产生不利影响。我们最近发现，补充氧气可能会改善早期神经功能恢复。在此，我们报告这项试点研究的六个月结果。
方法
临床诊断为急性中风的患者在入院后24小时内被随机分为两组，一组以2或3升/分钟的速度补充氧气72小时，另一组接受对照治疗（室内空气）。6个月时通过邮寄问卷评估结果（见下文）。分析采用意向性分析，设定统计学显著性为p≤0.05。
结果
在301名随机分组的患者中，两名拒绝/撤回同意，289名（吸氧组148名，对照组141名）纳入分析：两组男性分别占44%、51%；平均（标准差）年龄73（12）岁、71（12）岁；两组美国国立卫生研究院卒中量表评分中位数（四分位间距）分别为6（3，10）、5（3，10）。六个月时，吸氧组22名（15%）患者和对照组20名（14%）患者死亡；两组平均生存期均为162天（p = 0.99）。主要结局改良Rankin量表评分中位数（四分位间距），吸氧组和对照组分别为3（1，5）和3（1，4）。协变量调整后的优势比为1.04（95%可信区间0.67，1.60），表明吸氧组得分较低（即较好）的优势无显著提高（p = 0.86）。在进行基本日常生活活动（Barthel指数）和扩展日常生活活动（NEADL）的能力以及生活质量（欧洲生活质量量表）方面的平均差异也无显著性。
结论
两组在6个月时的关键结局均无差异。尽管差异无统计学显著性且一般幅度较小，但效应主要有利于吸氧组；一项旨在显示长期功能结局差异的更大规模试验正在进行中。
试验注册
Controlled-Trials.com ISRCTN12362720；Eudract.ema.europa.eu 2004-001866-41。
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