Department of Neurology, Royal Perth Hospital, Western Australia, Australia.
Clin Rehabil. 2012 Sep;26(9):787-97. doi: 10.1177/0269215511432016. Epub 2012 Feb 3.
To examine the safety and efficacy of onabotulinumtoxinA (Botox) for plantarflexor overactivity following stroke.
Double-blind randomized controlled trial, open-label extension phase.
Neurology rehabilitation facilities.
Eighty-five subjects with lower limb hypertonia received 200 U (n = 28) or 300 U (n = 28) of onabotulinumtoxinA or saline (n = 29) injection.
Plantarflexor Ashworth scores at 12 weeks post injection and adverse events. Secondary measures: self-reported spasm frequency and pain, physician rating of hypertonia severity, gait quality and active dorsiflexion.
Differences were not seen between onabotulinumtoxinA groups; hence data were pooled. Incidence of adverse events was not different between groups (P = 0.61). Reduction in hypertonia was not different between groups at 12 weeks (P = 0.53); however for subjects with Ashworth scores of >3 at baseline, 14/31 in the onabotulinumtoxinA group demonstrated a reduction of >1 grade versus 1/17 receiving placebo injection (P = 0.01). Overall, onabotulinumtoxinA-injected subjects demonstrated significantly greater improvement in spasm frequency (22/54 versus 4/29, P = 0.01), pain reduction (8/54 versus 1/29, P = 0.02), active dorsiflexion (8/54 versus 1/29 P = 0.03) and gait quality (17/54 versus 6/29, P = 0.02) than controls. In the open-label phase, a second onabotulinumtoxinA injection was associated with greater hypertonia reduction (P = 0.005) and gait quality (P = 0.002) compared with single injection.
OnabotulinumtoxinA injection for ankle flexor overactivity after stroke was safe and well tolerated but did not alter local spasticity at 12 weeks; it did reduce spasms and improve gait quality. There were no detectable differences between higher and lower doses. A second injection may be associated with greater change.
研究肉毒毒素 A（Botox）治疗脑卒中后腓肠肌过度活动的安全性和有效性。
双盲随机对照试验，开放标签扩展阶段。
神经病学康复设施。
85 名下肢张力过高的受试者接受了 200U（n=28）或 300U（n=28）肉毒毒素 A 或生理盐水（n=29）注射。
注射后 12 周时的腓肠肌 Ashworth 评分和不良反应。次要测量指标：自我报告的痉挛频率和疼痛、医生对肌张力严重程度的评估、步态质量和主动背屈。
肉毒毒素 A 组之间无差异，故数据合并。各组不良反应发生率无差异（P=0.61）。12 周时，各组的肌张力降低无差异（P=0.53）；然而，对于基线 Ashworth 评分>3 的受试者，肉毒毒素 A 组中有 14/31 例的评分降低>1 级，而接受安慰剂注射的受试者仅有 1/17 例（P=0.01）。总体而言，肉毒毒素 A 注射组的痉挛频率（22/54 与 4/29，P=0.01）、疼痛减轻（8/54 与 1/29，P=0.02）、主动背屈（8/54 与 1/29，P=0.03）和步态质量（17/54 与 6/29，P=0.02）均显著优于对照组。在开放标签阶段，与单次注射相比，第二次肉毒毒素 A 注射与更大的肌张力降低（P=0.005）和步态质量改善（P=0.002）相关。
肉毒毒素 A 注射治疗脑卒中后踝屈肌过度活动安全且耐受良好，但在 12 周时并未改变局部痉挛；它确实减少了痉挛并改善了步态质量。高剂量和低剂量之间没有可检测到的差异。第二次注射可能与更大的变化相关。
