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A型肉毒毒素与短期电刺激治疗脑卒中后上肢屈肌痉挛:一项随机、双盲、安慰剂对照试验

Botulinum toxin type A and short-term electrical stimulation in the treatment of upper limb flexor spasticity after stroke: a randomized, double-blind, placebo-controlled trial.

作者信息

Hesse S, Reiter F, Konrad M, Jahnke M T

机构信息

Klinik Berlin, Department of Neurological Rehabilitation, Free University of Berlin, Germany.

出版信息

Clin Rehabil. 1998 Oct;12(5):381-8. doi: 10.1191/026921598668275996.

DOI:10.1191/026921598668275996
PMID:9796928
Abstract

OBJECTIVE

To investigate whether the combined approach of botulinum toxin type A (BtxA) and electrical stimulation was more effective than the toxin alone in the treatment of chronic upper limb spasticity after stroke.

DESIGN

Randomized, placebo-controlled study with four treatment groups: 1000 units BtxA (Dysport) + electrical stimulation (A), 1000 units BtxA (B), placebo + electrical stimulation (C) and placebo (D).

SETTING

A neurological rehabilitation clinic.

SUBJECTS

Twenty-four stroke patients with chronic upper limb spasticity after stroke, six patients in each treatment group.

INTERVENTIONS

Intramuscular injection of either toxin or placebo into six upper imb flexor muscles. In group A and C additional electrical stimulation of the injected muscles with surface electrodes, three times half an hour each day for three days.

MAIN OUTCOME MEASURES

Muscle tone rated with the modified Ashworth score, limb position at rest and difficulties encountered during three upper limb motor tasks assessed before and 2, 6 and 12 weeks after injection.

RESULTS

Most improvements were observed in patients of group A. Cleaning the palm (p = 0.004) differed across groups. Pairwise comparison for this target variable showed that group A differed from group B and D (p <0.01), but not from C. Indicative across-group differences were obtained for elbow spasticity reduction (p = 0.011), and improvement of putting the arm through a sleeve (p = 0.020).

CONCLUSIONS

The placebo-controlled trial favours the concept that electrical stimulation enhances the effectiveness of BtxA in the treatment of chronic upper limb flexor spasticity after stroke.

摘要

目的

探讨A型肉毒毒素(BtxA)联合电刺激疗法在治疗脑卒中后慢性上肢痉挛方面是否比单纯使用毒素更有效。

设计

随机、安慰剂对照研究,分为四个治疗组:1000单位BtxA(Dysport)+电刺激(A组)、1000单位BtxA(B组)、安慰剂+电刺激(C组)和安慰剂(D组)。

地点

一家神经康复诊所。

研究对象

24例脑卒中后患有慢性上肢痉挛的患者,每个治疗组6例。

干预措施

将毒素或安慰剂肌肉注射到六块上肢屈肌中。A组和C组对注射肌肉用表面电极进行额外电刺激,每天三次,每次半小时,共三天。

主要观察指标

采用改良Ashworth评分评估肌张力,在注射前及注射后2周、6周和12周评估静息时肢体位置以及三项上肢运动任务中遇到的困难。

结果

A组患者改善最为明显。不同组间在清洁手掌方面存在差异(p = 0.004)。对该目标变量进行两两比较显示,A组与B组和D组存在差异(p <0.01),但与C组无差异。在肘部痉挛减轻(p = 0.011)和穿袖子动作改善方面(p = 0.020)存在组间显著差异。

结论

安慰剂对照试验支持电刺激可增强BtxA治疗脑卒中后慢性上肢屈肌痉挛有效性的观点。

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