Wissel J, Heinen F, Schenkel A, Doll B, Ebersbach G, Müller J, Poewe W
Department of Neurology, Universitätsklinik Innsbruck, Austria.
Neuropediatrics. 1999 Jun;30(3):120-4. doi: 10.1055/s-2007-973475.
The present study was performed to assess dose-response relationships of local botulinum toxin A (BtxA) treatment in children and teenagers with spastic gait due to cerebral palsy (CP) in a randomized, double-blind study employing a "high-dose" (200 units Botox per leg) and a "low-dose" (100 units Botox per leg) treatment arm in 33 patients with CP. Response parameters included changes in muscle tone assessed by the Ashworth scale at knee joint, range-of-motion (ROM) measurements at knee and ankle joint, objective analysis of longitudinal gait parameters as well as subjective assessments of improvement. Patients in the "high-dose" arm received 40-80 units Botox/muscle versus 20-40 units Botox/muscle in the "low-dose" group. Patients in both treatment arms showed significant improvement of Ashworth score (p<0.001) and ROM (p<0.01), while gait analysis revealed significant increase in gait velocity (p<0.01) and stride-length (p<0.001) over baseline. Subjects in the "high-dose" group showed significantly greater improvement on objective response measurements compared to "low-dose" patients. Also, children aged 7 years or less had greater functional benefit compared to the subgroup of patients older than 7 years. Incidence and severity of side-effects were similar in both treatment groups. The present study demonstrated dose-dependent functional improvement of dynamic deformities and spastic gait pattern in children and young adults with CP treated with local injections of botulinum toxin. A dose of 200 units Botox per leg distributed to 4 or 5 muscle bellies per leg is superior compared to 100 units Botox per leg without significantly affecting the risk of side-effects.
本研究旨在通过一项随机双盲研究，评估局部注射A型肉毒杆菌毒素（BtxA）治疗因脑瘫（CP）导致痉挛步态的儿童和青少年的剂量反应关系。该研究设立了“高剂量”（每腿注射200单位保妥适）和“低剂量”（每腿注射100单位保妥适）两个治疗组，共纳入33例CP患者。反应参数包括通过阿什沃思量表评估的膝关节肌张力变化、膝关节和踝关节的活动范围（ROM）测量、纵向步态参数的客观分析以及主观改善评估。“高剂量”组患者每块肌肉注射40 - 80单位保妥适，而“低剂量”组为每块肌肉注射20 - 40单位保妥适。两个治疗组的患者阿什沃思评分（p<0.001）和ROM（p<0.01）均有显著改善，同时步态分析显示与基线相比，步态速度（p<0.01）和步长（p<0.001）显著增加。与“低剂量”组患者相比，“高剂量”组患者在客观反应测量方面显示出更显著的改善。此外，7岁及以下儿童比7岁以上患者亚组获得了更大的功能益处。两个治疗组的副作用发生率和严重程度相似。本研究表明，局部注射肉毒杆菌毒素治疗的CP儿童和青年患者，其动态畸形和痉挛步态模式存在剂量依赖性功能改善。每腿注射200单位保妥适并分配到每腿4或5个肌腹优于每腿注射100单位保妥适，且不会显著影响副作用风险。
