电刺激定位引导肉毒毒素治疗脑性瘫痪患儿踝蹠屈肌群痉挛的对照研究

Effects of botulinum toxin guided by electric stimulation on spasticity in ankle plantar flexor of children with cerebral palsy: a randomized trial

目的 比较电刺激定位引导肉毒毒素A（BTX-A）注射结合物理治疗与单纯物理治疗对脑性瘫痪（脑瘫）患儿踝蹠屈肌群痉挛的临床疗效。方法 43例脑瘫患儿，年龄35～82个月（52．4±13．2个月），随机分为2组：①电刺激定位引导BTX-A注射结合物理治疗组（BTX-A组，23例）；②单纯物理治疗组（20例）。患儿入选后分别在治疗前，治疗后的2周、1、2．3个月进行以下评定：①踝关节被动活动范围（PROM），②改良Ashworth量表（MAS），③综合痉挛量表（css），④粗大运动功能量表（GMFM）中的D和E两项，⑤步行速度。BTX-A组在注射后72h、单纯物理治疗组入组后开始为期10d的物理治疗并配戴踝足矫形器，所有患儿10d后改由家长在家进行治疗。结果 两组患儿踝PROM、MAS、CSS、GMFM评分及步行速度治疗前差异无统计学意义（P〉0．05），治疗后2周、1、2．3个月组内差异均有统计学意义（P均〈0．001）。PROM、MAS、CSS评分治疗后2周、1、2．3个月组间差异均有统计学意义（治疗后3个月：t值分别为6．48、9．74、9．59，P均〈0．05）。GMFM评分治疗后1、2、3个月组间差异均有统计学意义（t值分别为2．20、3．26、4．13，P均〈0．05）。步行速度治疗后2、3个月组间差异均有统计学意义（t值分别为2．12、2．57，P均〈0．05）。结论 电刺激定位引导BTX-A注射结合物理治疗较单纯物理治疗能更好地缓解脑瘫患儿踝蹠屈肌群痉挛，提高患儿的运动能力。

Objective 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）. Methods 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. Results 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 ： tPROM = 6.48, tMAS = 9. 74, tCSS = 9. 59 ; P 〈 0. 05 ）. The difference in GMFM between the 2 groups was statistically significant （ t1M = 2. 20, t2m = 3. 26, t3M = 4. 13 ; P 〈 0.05 ） at 1, 2, and 3 months after treatment. The difference of WV between the 2 groups was statistically significant （ t2M = 2. 12, t3M = 2. 57 ; P 〈 0. 05 ） at 2 and 3 months after treatment. Conclusion 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.