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A型肉毒杆菌毒素对中风后患者的痉挛性肩部疼痛治疗有效吗?一项双盲随机临床试验。

Is botulinum toxin type A effective in the treatment of spastic shoulder pain in patients after stroke? A double-blind randomized clinical trial.

作者信息

Marco Ester, Duarte Esther, Vila Joan, Tejero Marta, Guillen Anna, Boza Roser, Escalada Ferran, Espadaler Josep M

机构信息

Physical Medicine and Rehabilitation Department, Hospital de l'Esperança, Sant Josep de la Muntanya, Barcelona, Spain.

出版信息

J Rehabil Med. 2007 Jul;39(6):440-7. doi: 10.2340/16501977-0066.

DOI:10.2340/16501977-0066
PMID:17624477
Abstract

OBJECTIVE

To determine the efficacy of botulinum toxin type A for the treatment of spastic shoulder pain in patients after stroke.

DESIGN

Double-blind randomized clinical trial.

PATIENTS

Of 31 patients enrolled from an acute-care hospital in Spain, 2 cases dropped out (drop-out rate 6.5%). Fourteen subjects were treated with infiltration of 500 units of botulinum toxin type A in the pectoralis major muscle of the paretic side, and 15 with a placebo.

METHODS

After infiltration, both groups received transcutaneous electrical nerve stimulation for 6 weeks. Patients were assessed by the use of the Visual Analogue Scale for pain. A good result concerning pain was considered when the Visual Analogue Scale score was below 33.3 mm or less than half the initial score. The patients were followed-up for 6 months.

RESULTS

The patients treated with botulinum toxin type A showed a significantly greater pain improvement from the first week post-infiltration. Persistent shoulder pain was observed more frequently in the placebo group, with relative risks in the range 0.32-0.41 during the follow-up period.

CONCLUSION

Patients with spastic shoulder pain treated with a botulinum toxin type A infiltration in the pectoralis major muscle of the paretic side have a higher likelihood of pain relief (between 2.43- and 3.11-fold).

摘要

目的

确定A型肉毒毒素治疗中风后患者痉挛性肩部疼痛的疗效。

设计

双盲随机临床试验。

患者

从西班牙一家急症医院招募的31例患者中,2例退出(退出率6.5%)。14名受试者在患侧胸大肌注射500单位A型肉毒毒素进行治疗,15名接受安慰剂治疗。

方法

注射后,两组均接受经皮电神经刺激治疗6周。使用视觉模拟评分法评估患者的疼痛情况。当视觉模拟评分低于33.3mm或低于初始评分的一半时,认为疼痛情况良好。对患者进行6个月的随访。

结果

注射A型肉毒毒素治疗的患者从注射后第一周起疼痛改善情况明显更佳。安慰剂组更频繁地出现持续性肩部疼痛,随访期间相对风险在0.32至0.41之间。

结论

在患侧胸大肌注射A型肉毒毒素治疗痉挛性肩部疼痛的患者,疼痛缓解的可能性更高(为2.43至3.11倍)。

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