中国神经再生研究(英文版)

中国神经再生研究(英文版) ›› 2017, Vol. 12 ›› Issue (9): 1451-1457.doi: 10.4103/1673-5374.215257

• 原著:脑损伤修复保护与再生 • 上一篇    下一篇

不同浓度和剂量A型肉毒毒素治疗脑卒中足痉挛：有效性与安全性评价

  

  • 收稿日期:2017-07-03 出版日期:2017-09-15 发布日期:2017-09-15
  • 基金资助:

    山东省科技发展计划项目（2012YD18031）

Therapeutic efficacy and safety of various botulinum toxin A doses and concentrations in spastic foot after stroke: a randomized controlled trial

Jiang Li1, Ru Zhang1, Bo-li Cui1, Yong-xiang Zhang1, Guang-tao Bai1, Si-shan Gao2, Wen-jian Li1   

  1. 1 Affiliated Hospital of Qingdao University, Qingdao, Shandong Province, China
    2 Department of Neurology, Traditional Medicine Hospital of Huangdao District, Qingdao, Shandong Province, China
  • Received:2017-07-03 Online:2017-09-15 Published:2017-09-15
  • Contact: Wen-jian Li, M.D.,lwj917@sina.com.
  • Supported by:

    This study was supported by a grant from the Shandong Science and Technology Development Plan Project in China, No. 2012YD18031.

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摘要：

A型肉毒毒素在治疗肢体痉挛上缺乏标准，因此试验设计拟确定A型肉毒毒素治疗肢体痉挛的最佳剂量和浓度。作者将89例卒中后足痉挛程度基本一致的患者按随机数字表法分为4组，分别以不同剂量(200 U/400 U)及浓度(50U/mL/100U/mL)组合的A型肉毒毒素注射患侧小腿三头肌和胫骨后肌。通过检测注射前及注射后4d，1，2，4，12周时改良的Ashworth分级评分、10米计时步行测试、Holden步行分级量表以及计时站起步行测试，结果显示不同剂量及浓度的A型肉毒毒素均可有效改善卒中后足痉挛患者的行走能力，起效时间为4-7d，作用持续12周，其中高剂量低浓度组合的效果最佳。结果表明A型肉毒毒素可以有效治疗卒中后足痉挛，且最佳剂量及浓度分别是400 U和50 U/mL。

orcid:0000-0002-7731-4812(Wen-jian Li)

关键词: 神经再生, 卒中, 足痉挛, A型肉毒毒素, 足内翻, 足下垂, 行走功能

Abstract:

No recommended guidelines currently exist for the therapeutic concentration or dose of botulinum toxin type A (BTXA) injected into the muscle to treat limb spasticity. Therefore, in this randomized controlled trial, we explored the safety and efficacy of two concentrations and two doses of BTXA in the treatment of spastic foot after stroke to optimize this treatment in these patients. Eligible patients (n = 104) were randomized into four groups. The triceps surae and tibialis posterior on the affected side were injected with BTXA at one of two doses (200 U or 400 U) and two concentrations (50 U/mL or 100 U/mL). The following assessments were conducted before as well as 4 days and 1, 2,4, and 12 weeks after treatment: spasticity, assessed using the modified Ashworth scale; basic functional mobility, assessed using a timed up and go test; pace, assessed using a 10-meter timed walking test; and the ability to walk, assessed using Holden’s graded scale and a visual analog scale. The reported results are based on the 89 patients that completed the study. We found significant differences for the two doses and concentrations of BTXA to improve the ability of patients to walk independently, with the high-dose/low-concentration combination providing the best effect. Onset and duration of the ameliorating effects of BTXA were 4–7 days and 12 weeks, respectively. Thus, BTXA effectively treated foot spasms after stroke at an optimal dose of 400 U and concentration of 50 U/mL.

Key words: nerve regeneration, stroke, foot spasms, botulinum toxin type A, foot varus, foot drop, walking function, neural regeneration