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脑卒中后早期康复或强化遥测:一项先导随机试验。

Very early rehabilitation or intensive telemetry after stroke: a pilot randomised trial.

机构信息

Academic Section of Geriatric Medicine, University of Glasgow, Glasgow, UK. p.langhorne @ clinmed.gla.ac.uk

出版信息

Cerebrovasc Dis. 2010;29(4):352-60. doi: 10.1159/000278931. Epub 2010 Jan 30.

DOI:10.1159/000278931
PMID:20130401
Abstract

BACKGROUND

Stroke patients are more likely to make a good recovery if they receive care in a well-organised stroke unit. However, there are uncertainties about how best to provide such care. We studied 2 key aspects of early stroke unit care: early active mobilisation (EM) and automated monitoring (AM) for physiological complications such as hypoxia.

METHODS

This was an observer-blinded, factorial (2 x 2) pilot randomised controlled trial recruiting stroke patients within 36 h of symptom onset. The patients were randomised to 1 of 4 nurse-led treatment protocols: (a) standard stroke unit care, (b) EM, (c) AM or (d) combined EM and AM. The primary outcome was the Rankin score at 3 months. We also report the data on feasibility and safety.

RESULTS

We randomised 32 patients (mean age = 65 years; mean baseline modified NIH score = 6). On unadjusted comparisons, the EM patients were significantly (p < 0.05) more likely to mobilise very early (within 1 h of randomisation) and to achieve walking by day 5 and were less likely to develop complications of immobility. The AM group was significantly (p < 0.05) more likely to have pre-defined physiological complication events detected. All these associations remained, but were less statistically significant, after correcting for age, baseline NIH score and co-interventions. There were no significant safety concerns.

DISCUSSION

We have demonstrated the feasibility of implementing EM and AM for physiological complications in a randomised controlled trial. Larger trials are warranted to determine whether these interventions have clinical benefits.

摘要

背景

如果中风患者在组织良好的中风单元中接受治疗,他们更有可能康复。然而,如何最好地提供这种护理存在不确定性。我们研究了中风单元护理的两个关键方面:早期主动活动(EM)和自动监测(AM)以预防缺氧等生理并发症。

方法

这是一项观察者盲、两因素(2×2)的先导随机对照试验,在发病后 36 小时内招募中风患者。患者被随机分配到 4 种护士主导的治疗方案之一:(a)标准中风单元护理;(b)EM;(c)AM;或(d)EM 和 AM 联合。主要结局是 3 个月时的 Rankin 评分。我们还报告了可行性和安全性的数据。

结果

我们随机分配了 32 名患者(平均年龄=65 岁;平均基线 NIH 评分=6)。在未调整的比较中,EM 组患者明显(p<0.05)更有可能在随机分组后 1 小时内进行早期活动,并在第 5 天实现行走,并且不太可能出现因活动受限引起的并发症。AM 组明显(p<0.05)更有可能检测到预先定义的生理并发症事件。在考虑年龄、基线 NIH 评分和合并干预后,这些关联仍然存在,但统计学意义较小。没有明显的安全问题。

讨论

我们已经证明了在随机对照试验中实施 EM 和 AM 以预防生理并发症的可行性。需要更大规模的试验来确定这些干预措施是否具有临床益处。

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