From the MossRehab Gait and Motion Analysis Laboratory, Elkins Park, Pennsylvania (AE); McGill University, Division of Neurology, Montreal General Hospital, Montreal, Quebec, Canada (THW); Staffordshire University, Faculty of Health and North Staffordshire Rehabilitation Centre, Haywood Hospital, Stoke-on-Trent, United Kingdom (ABW); Halifax Health, Brooks Rehabilitation, Daytona Beach, Florida (CG); Allergan plc, Bridgewater, New Jersey (CL); and Allergan plc, Irvine, California (RD).
Am J Phys Med Rehabil. 2019 May;98(5):360-368. doi: 10.1097/PHM.0000000000001101.
The aim of the study was to identify optimal muscle selection patterns for onabotulinumtoxinA treatment of poststroke lower-limb spasticity.
Adults with poststroke lower-limb spasticity (ankle Modified Ashworth Scale ≥3) were randomized to onabotulinumtoxinA (300 U, mandatory ankle plantar flexors; ≤100 U, optional lower-limb muscles) or placebo. Post hoc analysis assessed the impact of muscle selection patterns on ankle Modified Ashworth Scale and physician-assessed Clinical Global Impression of Change based on change from baseline to average of weeks 4/6 versus placebo.
Among 468 patients randomized, onabotulinumtoxinA improved ankle Modified Ashworth Scale (-0.81 vs -0.61, P = 0.01) and Clinical Global Impression of Change (0.86 vs 0.65, P = 0.012) versus placebo. Injection of mandatory muscles alone was not sufficient in improving ankle Modified Ashworth Scale (P = 0.255) or Clinical Global Impression of Change (P = 0.576) versus placebo but was adequate 24 mos or less after stroke (Modified Ashworth Scale, -1.13 vs -0.62, P = 0.019; Clinical Global Impression of Change, 1.24 vs 0.68, P = 0.006). Additional injections into toe muscles (flexor digitorum longus, flexor hallucis longus) improved ankle Modified Ashworth Scale (-0.98 vs -0.52, P = 0.002) and Clinical Global Impression of Change (0.80 vs 0.38, P = 0.023) versus placebo regardless of time since stroke. OnabotulinumtoxinA was well tolerated, with no new safety findings.
Post hoc analyses suggested additional injections of onabotulinumtoxinA into toe flexors improved ankle Modified Ashworth Scale and Clinical Global Impression of Change scores versus mandatory muscles alone overall and with treatment initiation more than 24 mos after stroke.
本研究旨在确定肉毒毒素 A 治疗脑卒中后下肢痉挛的最佳肌肉选择模式。
踝关节改良 Ashworth 量表≥3 的脑卒中后下肢痉挛患者（强制性踝跖屈肌 300U，可选下肢肌肉≤100U）被随机分为肉毒毒素 A（300U，强制性踝跖屈肌；≤100U，可选下肢肌肉）或安慰剂组。事后分析评估了肌肉选择模式对踝关节改良 Ashworth 量表和医生评估的基于从基线到第 4/6 周平均变化的临床整体印象变化的影响。
在 468 名随机患者中，肉毒毒素 A 改善了踝关节改良 Ashworth 量表（-0.81 比-0.61，P=0.01）和临床整体印象变化（0.86 比 0.65，P=0.012）与安慰剂相比。单独注射强制性肌肉不足以改善踝关节改良 Ashworth 量表（P=0.255）或临床整体印象变化（P=0.576）与安慰剂相比，但在脑卒中后 24 个月或更短时间内是足够的（改良 Ashworth 量表，-1.13 比-0.62，P=0.019；临床整体印象变化，1.24 比 0.68，P=0.006）。额外注射趾肌（趾长屈肌、踇长屈肌）可改善踝关节改良 Ashworth 量表（-0.98 比-0.52，P=0.002）和临床整体印象变化（0.80 比 0.38，P=0.023）与安慰剂相比，无论脑卒中发生时间如何。肉毒毒素 A 耐受性良好，无新的安全性发现。
事后分析表明，与单独注射强制性肌肉相比，整体而言，在脑卒中后 24 个月以上开始治疗时，额外注射肉毒毒素 A 至趾屈肌可改善踝关节改良 Ashworth 量表和临床整体印象变化评分。
