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[JAMA最新论文]:急性脑卒中患者常规使用低剂量氧疗不能改善3个月后病死率及致残率
2017年10月08日 时讯速递, 进展交流 暂无评论

Original Investigation

September 26, 2017

Effect of Routine Low-Dose Oxygen Supplementation on Death and Disability in Adults With Acute Stroke: The Stroke Oxygen Study Randomized Clinical Trial

Christine Roffe, Tracy Nevatte, Julius Sim, et al

JAMA. 2017;318(12):1125-1135. doi:10.1001/jama.2017.11463

Importance 背景

Hypoxia is common in the first few days after acute stroke, is frequently intermittent, and is often undetected. Oxygen supplementation could prevent hypoxia and secondary neurological deterioration and thus has the potential to improve recovery.

缺氧在急性卒中后最初数日内极为常见,且常为间断发生,经常未被发现。氧疗能够预防缺氧以及继发性神经系统功能恶化,从而可能改善患者病情恢复。

Objective 目的

To assess whether routine prophylactic low-dose oxygen therapy was more effective than control oxygen administration in reducing death and disability at 90 days, and if so, whether oxygen given at night only, when hypoxia is most frequent, and oxygen administration is least likely to interfere with rehabilitation, was more effective than continuous supplementation.

评价与控制氧疗相比,常规预防性低剂量氧疗能否更有效地降低90天病死率及致残率;如果答案是肯定的,那么仅在缺氧更为常见的夜间进行氧疗(此时氧疗对康复影响最小)是否较持续氧疗更有效。

Design, Setting, and Participants 设计,场景及研究对象

In this single-blind randomized clinical trial, 8003 adults with acute stroke were enrolled from 136 participating centers in the United Kingdom within 24 hours of hospital admission if they had no clear indications for or contraindications to oxygen treatment (first patient enrolled April 24, 2008; last follow-up January 27, 2015).

在这项单盲随机临床试验中,英国136个参研中心共入选8003名急性脑卒中成年患者(住院24小时内入选,如患者没有明确的氧疗适应症或禁忌症)(首例患者于2008年4月24日入选;最后随访于2015年1月27日完成)。

Interventions 干预措施

Participants were randomized 1:1:1 to continuous oxygen for 72 hours (n = 2668), nocturnal oxygen (21:00 to 07:00 hours) for 3 nights (n = 2667), or control (oxygen only if clinically indicated; n = 2668). Oxygen was given via nasal tubes at 3 L/min if baseline oxygen saturation was 93% or less and at 2 L/min if oxygen saturation was greater than 93%.

患者按照1:1:1的比例被随机分为持续氧疗72小时组(n = 2688),夜间氧疗 (21:00 to 07:00) 持续3个晚上组 (n = 2667),或对照组(仅当有临床指证时才进行氧疗;n = 2668)。如果基线氧饱和度不超过93%,则经鼻导管吸氧3 L/min,若基线氧饱和度超过93%,则经鼻导管吸氧2 L/min。

Main Outcomes and Measures 主要预后指标

The primary outcome was reported using the modified Rankin Scale score (disability range, 0 [no symptoms] to 6 [death]; minimum clinically important difference, 1 point), assessed at 90 days by postal questionnaire (participant aware, assessor blinded). The modified Rankin Scale score was analyzed by ordinal logistic regression, which yields a common odds ratio (OR) for a change from one disability level to the next better (lower) level; OR greater than 1.00 indicates improvement.

主要预后终点为改良Rankin评分(残疾程度,0 [无症状] 至 6 [死亡];有临床意义的最小差值,1分),通过邮寄调查问卷在90天进行评估(患者知晓,评估者设盲)。采用顺序logistic回归分析对改良Rankin评分进行分析,报告为聪一个残疾级别到下一个较好(较低)级别的公共比数比(OR);OR < 1.00提示结局改善。

Results 结果

A total of 8003 patients (4398 (55%) men; mean [SD] age, 72 [13] years; median National Institutes of Health Stroke Scale score, 5; mean baseline oxygen saturation, 96.6%) were enrolled. The primary outcome was available for 7677 (96%) participants. The unadjusted OR for a better outcome (calculated via ordinal logistic regression) was 0.97 (95% CI, 0.89 to 1.05; P = .47) for oxygen vs control, and the OR was 1.03 (95% CI, 0.93 to 1.13; P = .61) for continuous vs nocturnal oxygen. No subgroup could be identified that benefited from oxygen. At least 1 serious adverse event occurred in 348 (13.0%) participants in the continuous oxygen group, 294 (11.0%) in the nocturnal group, and 322 (12.1%) in the control group. No significant harms were identified.

共有8003名患者入选(4398 (55%) 名男性;平均 [SD] 年龄 72 [13] 岁;中位NIH卒中评分,5分;平均基线氧饱和度,96.6%)。共7677名 (96%) 患者可得到主要预后终点。与对照组相比,氧疗组更好预后的未校正OR(根据顺序logistic回归计算)为 0.97 (95% CI, 0.89 to 1.05; P = .47),与夜间氧疗相比,持续氧疗组更好预后的OR 为 1.03 (95% CI, 0.93 to 1.13; P = .61)。未能发现氧疗获益的亚组。持续氧疗组348 名 (13.0%) 患者至少发生一次严重不良事件,夜间氧疗组为294 例 (11.0%),对照组 322 例 (12.1%)。未发现显著危害。

Conclusions and Relevance 结论与意义

Among nonhypoxic patients with acute stroke, the prophylactic use of low-dose oxygen supplementation did not reduce death or disability at 3 months. These findings do not support low-dose oxygen in this setting.

在未发生缺氧的急性脑卒中患者,预防性使用低剂量氧疗不能降低3个月时的病死率或致残率。这些发现不支持在这种情况下进行低剂量氧疗。

Trial Registration

ISRCTN Identifier: ISRCTN52416964

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