The effect of botulinum toxin type A on the functional ability of the child with spastic hemiplegia a randomized controlled trial
The effect of botulinum toxin type A on the functional ability of the child with spastic hemiplegia a randomized controlled trial
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DOI：
10.1046/j.1468-1331.2001.00038.x
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发表时间：
2001-11-01
影响因子：
5.1
通讯作者：
Chauvel, PJ
中科院分区：
文献类型：
--
作者：
Love, SC;Valentine, JP;Chauvel, PJ
已证明，A 型肉毒毒素 (BTX-A) 注射可减轻痉挛儿童的痉挛状态并改善肌肉生长。据推测，BTX-A 允许学习更正常的运动模式。本研究的目的是测量这种治疗对功能能力的影响。通过粗大运动功能测量（GMFM）对痉挛性偏瘫脑瘫儿童进行测量。符合选择标准的3-13岁儿童采用配对设计随机分配到对照组或注射组。一场比赛构成了一名 6 个月内的儿童，其腓肠比目鱼肌的改良 Ashworth 评分 (MAS) 相同，并且粗大运动功能测量的目标分数与相同目标分数相差 10% 以内。十二对匹配的人被登记。在入组时以及注射后 1、3 和 6 个月测量结果。通过测量 MAS 来评估对 BTX-A 反应的时间过程。动态运动范围 (R1) 和静态肌肉长度 (R2)。使用 88 项 GMFM 评估运动功能，并使用 10 点视觉模拟量表评估家长满意度。使用 Wilcoxon 符号秩检验对 GMFM 进行配对比较表明，治疗组在 3 个月时的收益显着高于对照组 (P = 0.02)，在 6 个月时的差异甚至更大 (P = 0.004)。使用参数统计。 GMFM 比例变化的配对内差异从 3 个月时的 35%（4 至 65）增加到 6 个月时的 52%（17-87）。治疗组 MAS 下降，而对照组变化很小，证实了对注射的反应。这种差异在 3 个月时显着 (P = 0.002)，在 6 个月时有所减弱，但仍然显着 (P = 0.016)：比例变化的差异从 3 个月时的 44% 下降到 6 个月时的 22%。 R1 的变化反映了治疗组中 MAS 的变化，而对照组在研究期间显着恶化。治疗组儿童的家长比对照组的家长更满意。但满意度得分与功能或技术结果的变化无关，表明这可能是安慰剂效应。 GMFM 的变化与 3 个月时技术成果的变化相关。暗示因果关系。即使在局部注射反应开始减弱后，GMFM 的对内差异仍在继续增加。
It has been demonstrated that botulinum toxin type A (BTX-A) injections reduce spasticity and improve muscle growth in children with spasticity. It has been postulated that BTX-A allows the learning of more normal movement patterns. The aim of this study was to measure the effect of this treatment on functional ability. as measured by the Gross Motor Function Measure (GMFM), in children with spastic hemiplegic cerebral palsy. Children of 3-13 years and meeting the selection criteria were randomly allocated to the control or injection group using a matched pair design. A match constituted a child within 6 months of age with the same Modified Ashworth Score (MAS) for the gastroc-soleus and within 10% of the same goal scores on the Gross Motor Function Measure. Twelve matched pairs were enrolled. Outcomes were measured on enrolment and at 1. 3 and 6 months post injection. The time course of the response to BTX-A was assessed with measurements of the MAS. dynamic range of motion (R1) and static muscle length (R2). Motor function was assessed using the 88-item GMFM and parental satisfaction with a 10-point visual analogue scale. Within pair comparisons of the GMFM using the Wilcoxon signed rank test indicated that the treatment group made significantly greater gains than controls at 3 months (P = 0.02) with even greater differences seen at 6 months (P = 0.004). Using parametric statistics. the intrapair difference in proportional change of GMFM increased from 35% (4 to 65) at 3 months to 52% (17-87) at 6 months. Response to injection was confirmed by a decrease in MAS in the treatment group and very little change in controls. This difference was significant (P = 0.002) at 3 months and was attenuated but still significant (P = 0.016) at 6 months: the difference in proportional change decreased from 44% at 3 months to 22% at 6 months. Changes in R1 reflected those of MAS in the treatment group and deteriorated significantly over the study period in controls. Parents of children in the treatment group were more satisfied than controls. but satisfaction scores did not correlate with changes in function or technical outcomes suggesting that this may be a placebo effect. The changes in GMFM correlated with changes in technical outcomes at 3 months. suggesting a causal relationship. The intrapair differences in GMFM continued to increase even after the local response to injection had started to wane.