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肉毒杆菌毒素注射治疗颈部肌张力障碍的双盲、安慰剂对照研究。

Double-blind, placebo-controlled study of botulinum toxin injections in the treatment of cervical dystonia.

作者信息

Lu C S, Chen R S, Tsai C H

机构信息

First Department of Neurology, Chang Gung Memorial Hospital, Taipei, Taiwan ROC.

出版信息

J Formos Med Assoc. 1995 Apr;94(4):189-92.

PMID:7606182
Abstract

Botulinum toxin injections were given to 23 patients with cervical dystonia in a double-blind, placebo-controlled, crossover study. Each patient was randomly given 100 units of botulinum A toxin and placebo in two respective sets of injections into the two most active contracting neck muscles at least 3 months apart. Before and 3 weeks after each set of injections, the cervical dystonia was "blindly" scored by the investigator. Each patient was also asked to independently score the improvement of the dystonia and neck pain. Four patients dropped out and one patient showed spontaneous remission. The remaining 18 patients completed the study and showed a significant improvement after the injections of botulinum toxin in comparison with that of the placebo. The effect started about 1 week after injection and the maximal effect lasted about 11 weeks in patients with a satisfactory response. The neck pain was satisfactorily relieved in 9 of 10 patients affected. There were no significant side effects. Thus, botulinum toxin injection is effective in treating cervical dystonias; injection of a higher dose of botulinum toxin in a greater number of neck muscles is required for those patients with complex cervical dystonia.

摘要

在一项双盲、安慰剂对照、交叉研究中,对23例颈部肌张力障碍患者进行了肉毒杆菌毒素注射。每位患者被随机给予100单位的A型肉毒杆菌毒素和安慰剂,分别在两组注射中注入两块最活跃收缩的颈部肌肉,且两次注射间隔至少3个月。在每组注射前和注射后3周,由研究者对颈部肌张力障碍进行“盲法”评分。每位患者还被要求独立对肌张力障碍和颈部疼痛的改善情况进行评分。4例患者退出研究,1例患者出现自发缓解。其余18例患者完成了研究,与注射安慰剂相比,注射肉毒杆菌毒素后有显著改善。对于反应良好的患者,效果在注射后约1周开始显现,最大效果持续约11周。10例受影响患者中有9例颈部疼痛得到满意缓解。未出现明显副作用。因此,肉毒杆菌毒素注射治疗颈部肌张力障碍有效;对于复杂颈部肌张力障碍患者,需要在更多颈部肌肉中注射更高剂量的肉毒杆菌毒素。

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Double-blind, placebo-controlled study of botulinum toxin injections in the treatment of cervical dystonia.肉毒杆菌毒素注射治疗颈部肌张力障碍的双盲、安慰剂对照研究。
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