Kurenkov A L, Klochkova O A, Bursagova B I, Karimova H M, Kuzenkova L M, Mamedyarov A M, Namazova-Baranova L S, Agranovich O V, Agranovich A O, Soboleva O A, Khapaeva M M, Batysheva T T, Sarzhina M N
National medical research center of Children Health, Ministry of Health of Russia, Moscow, Russia.
Stavropol State Medical University, Ministry of Healthcare of Russia, Stavropol, Russia.
Zh Nevrol Psikhiatr Im S S Korsakova. 2017;117(11):37-44. doi: 10.17116/jnevro201711711137-44.
To assess the safety and clinical and neurophysiological efficacy of xeomin in children with spastic equinus and equinovarus foot deformity in cerebral palsy.
Sixty-four patients with spastic forms of cerebral palsy (levels I-IV on the GMFCS) were enrolled into this multi-center open-label comparative randomized trial. The patients were administered xeomin or botox once, each drug being administered to 32 patients. Efficacy was evaluated based on clinical characteristics (the modified Ashworth scale, goniometry) and electromyography data. The subjects were observed for 3 months (90±7 days) after injections. The incidence, severity and intensity of adverse events (AE) was also determined.
Treatment with xeomin according to the suggested protocol has proven its high clinical efficacy. The efficacy was demonstrated by significant, stable and long-term decrease in the gastrocnemius muscle tone: in the xeomin group, the score on the modified Ashworth scale decreased from 2.6±0.49 points at baseline to 1.8±0.54 points (р<0.000001, paired t-test; р<0.000004, Wilcoxon test). In the botox group, this score decreased from 2.4±0.56 points to 1.6±0.45 points (р<0.000001, paired t-test; р<0.000002, Wilcoxon test). The increased range of ankle joint movements at passive and voluntary feet extension. In the xeomin group, the significant proportion of patients (45.1%) moved to the group of lower spasticity defined as less than two score points on the modified Ashworth scale. The clinical data fully matched the changes in electromyography parameters, which were characterized by the lower amplitude and area of the target muscle (lateral and medial gastrocnemius heads) M-responses. AE developed in three patients (9.4%) administered xeomin and in two patients (6.3%) administered botox. The AE recorded in the study are described in the recommendations on the use of xeomin and botox. In three cases (50.0%), AE intensity was determined as mild, in the remaining three cases (50.0%) as moderate.
The results have shown the safety and efficacy of xeomin in the treatment of gastrocnemius spasticity in pediatric patients with cerebral palsy. These data are confirmed by the lack of significant differences in any clinical or electromyography parameters with the results in the reference group administered botox.
评估Xeomin（肉毒杆菌素）治疗脑瘫患儿痉挛性马蹄内翻足畸形的安全性、临床疗效及神经生理学疗效。
64例痉挛型脑瘫患者（GMFCS分级为I-IV级）纳入这项多中心开放标签对照随机试验。患者接受一次Xeomin或肉毒杆菌素注射，每种药物各治疗32例患者。根据临床特征（改良Ashworth量表、角度测量）和肌电图数据评估疗效。注射后对受试者观察3个月（90±7天）。还确定了不良事件（AE）的发生率、严重程度和强度。
按照推荐方案使用Xeomin治疗已证明其具有较高的临床疗效。疗效表现为腓肠肌肌张力显著、稳定且长期降低：Xeomin组改良Ashworth量表评分从基线时的2.6±0.49分降至1.8±0.54分（配对t检验，р<0.000001；Wilcoxon检验，р<0.000004）。肉毒杆菌素组该评分从2.4±0.56分降至1.6±0.45分（配对t检验，р<0.000001；Wilcoxon检验，р<0.000002）。被动和主动伸足时踝关节活动范围增加。Xeomin组有相当比例的患者（45.1%）进入改良Ashworth量表评分低于2分的低痉挛组。临床数据与肌电图参数变化完全相符，其特征为目标肌肉（腓肠肌内外侧头）M波幅和面积降低。接受Xeomin治疗的3例患者（9.4%）和接受肉毒杆菌素治疗的2例患者（6.3%）出现AE。研究中记录的AE在Xeomin和肉毒杆菌素使用建议中有描述。3例（50.0%）AE强度为轻度，其余3例（50.0%）为中度。
结果表明Xeomin治疗小儿脑瘫患者腓肠肌痉挛安全有效。与肉毒杆菌素治疗的参照组结果相比，任何临床或肌电图参数均无显著差异，证实了这些数据。
