Royal Melbourne Hospital, Melbourne, Australia.
Neurology. 2012 Jul 3;79(1):92-9. doi: 10.1212/WNL.0b013e31825dcdd9.
To evaluate the safety and efficacy of botulinum toxin type A in disabling multiple sclerosis (MS)-related upper limb tremor.
Twenty-three patients with MS contributed data from 33 upper limbs to this study. Each limb was randomized in a crossover design to receive botulinum toxin type A or placebo at baseline and the reverse treatment at 12 weeks. The 3 main outcomes were the median changes in Bain tremor rating scores for tremor severity, writing, and drawing an Archimedes spiral from baseline to 6 and 12 weeks after treatment with botulinum toxin type A compared with those after treatment with saline placebo. An independent rater scored randomized video assessments performed every 6 weeks over 6 months.
There was a significant improvement after botulinum toxin compared with that after placebo treatment in the Bain score for tremor severity at 6 weeks (p = 0.0005) and 12 weeks (p = 0.0001), writing at 6 weeks (p = 0.0001) and 12 weeks (p = 0.0003), and Archimedes spiral drawing at 6 weeks (p = 0.0006) and 12 weeks (p = 0.0002). More patients developed weakness after botulinum toxin treatment (42.2%) than after placebo injection (6.1%; (p = 0.0005). Weakness was mild (just detectable) to moderate (still able to use limb) and resolved within 2 weeks.
Targeted botulinum toxin type A injections significantly improve arm tremor and tremor-related disability in patients with MS.
This study provides Class III evidence that targeted injection of botulinum toxin type A is associated with significant improvement in MS-related upper limb tremor.
评估肉毒毒素 A 治疗多发性硬化症（MS）相关上肢震颤的安全性和有效性。
本研究纳入了 23 名 MS 患者的 33 只上肢，每只上肢均采用交叉设计，在基线时随机接受肉毒毒素 A 或安慰剂治疗，12 周后进行反向治疗。3 个主要结局指标为：与生理盐水安慰剂治疗相比，治疗后 6 周和 12 周时，肉毒毒素 A 治疗组 Bain 震颤严重程度评分、书写和绘制阿基米德螺旋的中位数变化。由独立评估者对随机视频评估进行评分，评估时间为 6 个月内的每 6 周一次。
与安慰剂治疗相比，肉毒毒素 A 治疗后 6 周（p = 0.0005）和 12 周（p = 0.0001）时震颤严重程度的 Bain 评分、6 周（p = 0.0001）和 12 周（p = 0.0003）时书写评分以及 6 周（p = 0.0006）和 12 周（p = 0.0002）时阿基米德螺旋绘图评分均显著改善。与安慰剂注射相比（6.1%），更多患者在肉毒毒素 A 治疗后出现无力（42.2%）（p = 0.0005）。无力程度为轻度（仅可检测到）至中度（仍能使用肢体），并在 2 周内得到缓解。
靶向肉毒毒素 A 注射可显著改善 MS 患者的手臂震颤和震颤相关残疾。
本研究提供了 III 级证据，表明靶向注射肉毒毒素 A 可显著改善 MS 相关上肢震颤。
