SOS 初步研究：急性脑卒中后早期常规氧疗的随机对照试验——对 1 周时神经功能恢复的影响。
The SOS pilot study: a RCT of routine oxygen supplementation early after acute stroke--effect on recovery of neurological function at one week.
机构信息
Stoke Stroke Research Group, North Staffordshire Combined Healthcare Trust, Stoke-On-Trent, Staffordshire, United Kingdom.
出版信息
PLoS One. 2011;6(5):e19113. doi: 10.1371/journal.pone.0019113. Epub 2011 May 19.
UNLABELLED
Mild hypoxia is common after stroke and associated with poor long-term outcome. Oxygen supplementation could prevent hypoxia and improve recovery. A previous study of routine oxygen supplementation showed no significant benefit at 7 and 12 months. This pilot study reports the effects of routine oxygen supplementation for 72 hours on oxygen saturation and neurological outcomes at 1 week after a stroke.
METHODS
Patients with a clinical diagnosis of acute stroke were recruited within 24 h of hospital admission between October 2004 and April 2008. Participants were randomized to oxygen via nasal cannulae (72 h) or control (room air, oxygen given only if clinically indicated). Clinical outcomes were assessed by research team members at 1 week. Baseline data for oxygen (n = 148) and control (n = 141) did not differ between groups.
RESULTS
The median (interquartile range) National Institutes of Health Stroke Scale (NIHSS) score for the groups at baseline was 6 (7) and 5 (7) respectively. The median Nocturnal Oxygen Saturation during treatment was 1.4% (0.3) higher in the oxygen than in the control group (p<0.001) during the intervention. At 1 week, the median NIHSS score had reduced by 2 (3) in the oxygen and by 1 (2) in the control group. 31% of participants in the oxygen group and 14% in the control group had an improvement of ≥4 NIHSS points at 1 week doubling the odds of improvement in the oxygen group (OR: 2.9).
CONCLUSION
Our data show that routine oxygen supplementation started within 24 hours of hospital admission with acute stroke led to a small, but statistically significant, improvement in neurological recovery at 1 week. However, the difference in NIHSS improvement may be due to baseline imbalance in stroke severity between the two groups and needs to be confirmed in a larger study and linked to longer-term clinical outcome.
TRIAL REGISTRATION
Controlled-Trials.com ISRCTN12362720; European Clinical Trials Database 2004-001866-41.
背景
中风后常出现轻度缺氧，且与长期预后不良相关。氧疗可预防缺氧并促进康复。既往常规氧疗的研究显示，7 个月和 12 个月时无显著获益。本研究旨在报道中风后 72 小时内常规氧疗对 1 周时氧饱和度和神经功能结局的影响。
方法
2004 年 10 月至 2008 年 4 月间，患者入院 24 小时内，经临床诊断为急性中风后，即被纳入本研究。参与者随机分为氧疗组（72 小时经鼻导管吸氧）和对照组（空气，仅在临床需要时给予氧疗）。研究团队成员于 1 周时评估临床结局。氧疗组（n=148）和对照组（n=141）的基线数据无组间差异。
结果
两组的基线 NIHSS 评分中位数（四分位数间距）分别为 6（7）和 5（7）。治疗期间，氧疗组的夜间氧饱和度中位数较对照组高 1.4%（0.3）（p<0.001）。1 周时，氧疗组 NIHSS 评分降低 2（3）分，对照组降低 1（2）分。氧疗组 31%和对照组 14%的患者在 1 周时 NIHSS 评分改善≥4 分，氧疗组改善的可能性是对照组的两倍（OR：2.9）。
结论
我们的数据表明，中风入院后 24 小时内开始常规氧疗可导致 1 周时神经功能恢复的小但有统计学意义的改善。然而，NIHSS 改善的差异可能是由于两组间基线中风严重程度的不平衡，需要在更大的研究中加以证实，并与更长期的临床结局相关联。
试验注册
controlled-trials.com ISRCTN83206465；European Clinical Trials Database 2004-001866-41。
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