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卑尔根卒中早期支持出院(ESD 卒中卑尔根):一项随机对照试验的 3 个月和 6 个月结果,比较两种早期支持出院方案与常规治疗。

Early supported discharge after stroke in Bergen (ESD Stroke Bergen): three and six months results of a randomised controlled trial comparing two early supported discharge schemes with treatment as usual.

作者信息

Hofstad Håkon, Gjelsvik Bente Elisabeth Bassøe, Næss Halvor, Eide Geir Egil, Skouen Jan Sture

出版信息

BMC Neurol. 2014 Dec 21;14:239. doi: 10.1186/s12883-014-0239-3.

Abstract

BACKGROUND

Stroke causes lasting disability and the burden of stroke is expected to increase substantially during the next decades. Optimal rehabilitation is therefore mandatory. Early supported discharge (ESD) has previously shown beneficial, but all major studies were carried out more than ten years ago. We wanted to implement and study the results of ESD in our community today with comparisons between ESD and treatment as usual, as well as between two different ESD models.

METHODS

Patients with acute stroke were included during a three year period (2008-11) in a randomised controlled study comparing two different ESD models to treatment as usual. The two ESD models differed by the location of treatment: either in a day unit or in the patients' homes. Patients in the ESD groups were followed by a multi-disciplinary ambulatory team in the stroke unit and discharged home as early as possible. The ESD models also comprised treatment by a multi-disciplinary community health team for up to five weeks and follow-up controls after 3 and 6 months. Primary outcome was modified Rankin Scale (mRS) at six months.

RESULTS

Three-hundred-and-six patients were included. mRS scores and change scores were non-significantly better in the two ESD groups at 3 and 6 months. Within-group improvement from baseline to 3 months was significant in the ESD 1 (p = 0.042) and ESD 2 (p = 0.001) groups, but not in the controls. More patients in the pooled ESD groups were independent at 3 (p = 0.086) and 6 months (p = 0.122) compared to controls and there also was a significant difference in 3 month change score between them (p = 0.049). There were no differences between the two ESD groups. Length of stay in the stroke unit was 11 days in all groups.

CONCLUSIONS

Patients in the ESD groups tended to be more independent than controls at 3 and 6 months, but no clear statistically significant differences were found. The added effect of supported discharge and improved follow-up seems to be rather modest. The improved stroke treatment of today may necessitate larger patient samples to demonstrate additional benefit of ESD.

CLINICAL TRIAL REGISTRATION

Unique identifier: NCT00771771.

摘要

背景

中风会导致永久性残疾,预计在未来几十年中风负担将大幅增加。因此,最佳康复治疗必不可少。早期支持出院(ESD)此前已显示出益处,但所有主要研究都是在十多年前进行的。我们希望在如今的社区中实施并研究ESD的效果,并比较ESD与常规治疗,以及两种不同ESD模式之间的差异。

方法

在一项为期三年(2008 - 2011年)的随机对照研究中,纳入急性中风患者,比较两种不同的ESD模式与常规治疗。两种ESD模式的治疗地点不同:一种是在日间病房,另一种是在患者家中。ESD组的患者由卒中单元的多学科门诊团队进行随访,并尽早出院回家。ESD模式还包括由多学科社区健康团队进行长达五周的治疗以及在3个月和6个月后的随访检查。主要结局指标是6个月时的改良Rankin量表(mRS)评分。

结果

共纳入306例患者。在3个月和6个月时,两个ESD组的mRS评分和变化评分虽有改善但无显著差异。从基线到3个月,ESD 1组(p = 0.042)和ESD 2组(p = 0.001)组内改善显著,而对照组无显著改善。与对照组相比,合并的ESD组中更多患者在3个月(p = 0.086)和6个月(p = 0.122)时能够独立,并且两组在3个月时的变化评分也存在显著差异(p = 0.049)。两个ESD组之间无差异。所有组在卒中单元的住院时间均为11天。

结论

ESD组患者在3个月和6个月时比对照组更倾向于能够独立,但未发现明显的统计学显著差异。支持出院和改善随访的附加效果似乎相当有限。如今中风治疗的改善可能需要更大的患者样本量才能证明ESD的额外益处。

临床试验注册

唯一标识符:NCT00771771。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8dc4/4301654/2cdc5299a6e7/12883_2014_239_Fig1_HTML.jpg

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