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右旋苯丙胺改善脑卒中后康复期间上肢结局:一项先导随机对照试验。

Dexamphetamine improves upper extremity outcome during rehabilitation after stroke: a pilot randomized controlled trial.

机构信息

Reha Rheinfelden, Rheinfelden, Switzerland.

出版信息

Neurorehabil Neural Repair. 2011 Oct;25(8):749-55. doi: 10.1177/1545968311405674. Epub 2011 Jun 28.

DOI:10.1177/1545968311405674
PMID:21712481
Abstract

BACKGROUND

For early inpatient stroke rehabilitation, the effectiveness of amphetamine combined with physiotherapy varies across studies.

OBJECTIVE

To investigate whether the recovery of activities of daily living (ADL, primary outcome) and motor function (secondary outcome) can be improved by dexamphetamine added to physiotherapy.

METHODS

In a double-blind, placebo-controlled trial, 16 patients, from 918 who were screened, were randomized to the experimental group (EG, dexamphetamine + physiotherapy) or control group (CG, placebo + physiotherapy). Both groups received multidisciplinary inpatient rehabilitation. Dexamphetamine (10 mg oral) or placebo was administered 2 days per week before physiotherapy. ADL and motor function were measured using the Chedoke-McMaster Stroke Assessment (CMSA) twice during baseline, every week during the 5-week treatment period, and at follow-up 1 week, 6 months, and 12 months after intervention.

RESULTS

The majority of ineligible patients had too little paresis, were on anticoagulants, or had a stroke >60 days prior to entry. Participants (EG, n = 7, age 70.3 ± 10 years, 5 women, 37.9 ± 9 days after stroke; CG, n = 9, age 65.2 ± 17 years, 3 women, 40.3 ± 9 days after stroke) did not differ at baseline except for the leg subscale. Analysis of variance from baseline to 1 week follow-up revealed significant improvements in favor of EG for subscales ADL (P = .023) and arm function (P = .020) at end of treatment. No adverse events were detected.

CONCLUSION

In this small trial that was based on prior positive trials, significant gains in ADL and arm function suggest that the dose and timing of dexamphetamine can augment physiotherapy. Effect size calculation suggests inclusion of at least 25 patients per group in future studies.

摘要

背景

在早期住院卒中康复中,安非他命联合物理疗法的疗效在不同研究中存在差异。

目的

研究添加右苯丙胺(dexamphetamine)是否可以改善物理疗法对日常生活活动(ADL,主要结局)和运动功能(次要结局)的恢复。

方法

在一项双盲、安慰剂对照试验中,从 918 名筛选出的患者中,有 16 名患者被随机分配到实验组(EG,右苯丙胺+物理疗法)或对照组(CG,安慰剂+物理疗法)。两组均接受多学科住院康复治疗。在物理治疗前每周 2 天给予右苯丙胺(10mg 口服)或安慰剂。在基线时使用 Chedoke-McMaster 卒中评估量表(CMSA)测量 ADL 和运动功能,在 5 周治疗期间每周测量两次,在干预后 1 周、6 个月和 12 个月进行随访。

结果

大多数不合格的患者肌无力程度较小、正在服用抗凝药物或卒中发生时间超过 60 天。参与者(EG,n = 7,年龄 70.3 ± 10 岁,5 名女性,卒中后 37.9 ± 9 天;CG,n = 9,年龄 65.2 ± 17 岁,3 名女性,卒中后 40.3 ± 9 天)除了腿部亚量表外,在基线时没有差异。从基线到 1 周随访的方差分析显示,在治疗结束时,EG 对 ADL(P =.023)和手臂功能(P =.020)亚量表的改善具有显著优势。未发现不良事件。

结论

在这项基于先前阳性试验的小型试验中,ADL 和手臂功能的显著改善表明右苯丙胺的剂量和时间可以增强物理疗法的效果。效应量计算表明,未来的研究中每组至少需要纳入 25 名患者。

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