Xu Kai-shou, Yan Tie-bin, Mai Jian-ning
Department of Neurology and Rehabilitation, Guangzhou Children's Hospital, Guangzhou 510120, China.
Zhonghua Er Ke Za Zhi. 2006 Dec;44(12):913-7.
To compare the effects of botulinum toxin A (BTX-A) injection guided by electric stimulation combined with physiotherapy, with physiotherapy only on the spasticity of the ankle plantar flexor in children with cerebral palsy (CP).
After signing the informed consent, 43 children with CP, aged 52.4 +/- 13.2 months (35 to 82 months), were randomly assigned into 2 groups, (1) BTX-A group (n = 23) treated with BTX-A injection guided by electric stimulation and (2) physiotherapy alone group (n = 20). Children in BTX-A group received injection of HengLi BTX-A in the ankle plantar flexors. A maximum dose of 12 units of BTX-A per kilogram body weight and maximumly 10 units of BTX-A per site were administered. Localization technique was the use of electrical stimulation guidance. Physiotherapy and ankle-foot orthosis were applied to children at 72 hours after injection in BTX-A group and at the time of being recruited into physiotherapy group. Ten days after entering into the study, the program was applied by the parents. Demographic data, including age, gender, number of the spastic lower limbs, affected side (left or right) were recorded. Clinical assessments included the range of passive movement (PROM) measured by goniometer while children maintained the knee extended, modified Ashworth scale (MAS), composite spasticity scale (CSS), D and E dimensions of the Gross Motor Function Measure (GMFM), and walking velocity (WV) was determined before treatment and at 2 weeks, 1, 2, and 3 months after treatment.
No statistically significant differences were found in age, gender, number of the spastic lower limbs, affected side, as well as clinical assessments (PROM, MAS, CSS, GMFM and WV) before treatment between the 2 groups (P > 0.05). All the children showed a reduction of spasticity (PROM, MAS and CSS) after 2 weeks, 1, 2, and 3 months of treatment (P < 0.05). When compared with the baseline findings, the improvement of standing and walking (GMFM), walking velocity were statistically significant after 2 weeks, 1, 2, and 3 months of treatment (P < 0.05). Furthermore, the differences of PROM, MAS and CSS between the 2 groups at 2 weeks, 1, 2, and 3 months examination were also statistically significant (after 3 months of treatment: t(PROM) = 6.48, t(MAS) = 9.74, t(CSS) = 9.59; P < 0.05). The difference in GMFM between the 2 groups was statistically significant (t(1M) = 2.20, t(2M) = 3.26, t(3M) = 4.13; P < 0.05) at 1, 2, and 3 months after treatment. The difference of WV between the 2 groups was statistically significant (t(2M) = 2.12, t(3M) = 2.57; P < 0.05) at 2 and 3 months after treatment.
BTX-A injection guided by electrical stimulation in combination with physiotherapy was more effective than physiotherapy alone in terms of reducing spasticity and improving functional performance in standing, walking, walking pattern and velocity on spasticity in ankle plantar flexors of ambulant children with CP.
比较电刺激引导下肉毒毒素A（BTX-A）注射联合物理治疗与单纯物理治疗对脑瘫（CP）患儿踝跖屈肌痉挛的影响。
签署知情同意书后，将43例年龄为52.4±13.2个月（35至82个月）的CP患儿随机分为两组，（1）BTX-A组（n = 23），采用电刺激引导下的BTX-A注射治疗；（2）单纯物理治疗组（n = 20）。BTX-A组患儿在踝跖屈肌注射衡力BTX-A。每千克体重最大注射剂量为12单位BTX-A，每个部位最大注射10单位。定位技术采用电刺激引导。BTX-A组患儿在注射后72小时以及单纯物理治疗组患儿在入组时接受物理治疗和踝足矫形器治疗。进入研究10天后，由家长实施该方案。记录人口统计学数据，包括年龄、性别、痉挛性下肢数量、患侧（左或右）。临床评估包括在患儿膝关节伸展时用角度计测量的被动活动范围（PROM）、改良Ashworth量表（MAS）、综合痉挛量表（CSS）、粗大运动功能测量（GMFM）的D和E维度，以及在治疗前、治疗后2周、1、2和3个月测定步行速度（WV）。
两组在年龄、性别、痉挛性下肢数量、患侧以及治疗前的临床评估（PROM、MAS、CSS、GMFM和WV）方面均无统计学显著差异（P>0.05）。所有患儿在治疗2周、1、2和3个月后痉挛程度（PROM、MAS和CSS）均有所降低（P<0.05）。与基线结果相比，治疗2周、1、2和3个月后站立和行走（GMFM）、步行速度的改善具有统计学意义（P<0.05）。此外，两组在治疗2周、1、2和3个月时PROM、MAS和CSS的差异也具有统计学意义（治疗3个月后：t(PROM)=6.48，t(MAS)=9.74，t(CSS)=9.59；P<0.05）。两组在治疗后1、2和3个月时GMFM的差异具有统计学意义（t(1M)=2.20，t(2M)=3.26，t(3M)=4.13；P<0.05）。两组在治疗后2和3个月时WV的差异具有统计学意义（t(2M)=2.12，t(3M)=2.57；P<0.05）。
对于能行走的CP患儿，电刺激引导下的BTX-A注射联合物理治疗在减轻踝跖屈肌痉挛以及改善站立、行走、步行模式和速度的功能表现方面比单纯物理治疗更有效。
