Ade-Hall R A, Moore A P
Clinical Trials Unit, Walton Centre for Neurology and Neurosurgery, Lower Lane, Fazakerley, Liverpool, UK, L9 7LJ.
Cochrane Database Syst Rev. 2000(2):CD001408. doi: 10.1002/14651858.CD001408.
To determine whether botulinum toxin (BtA) is an effective and safe treatment for lower limb spasticity in children with cerebral palsy. Functional outcomes are of particular interest.
Studies for inclusion in the review were identified using the Movement Disorders Review Group trials register, the Cochrane Controlled Trials Register, MEDLINE, pharmaceutical company databases, communication with other researchers in the field and reference lists of papers found using above search strategies.
Studies were considered eligible for inclusion in the review if they evaluated the efficacy of BtA for the treatment of leg spasticity in children with cerebral palsy. They must have been randomised and include a concurrent control group receiving another intervention.
A paper pro forma was used to collect data from the included studies using double extraction by two independent reviewers. Each trial was assessed for internal validity by each of the two reviewers. Meta-analysis was not possible because results were presented in an incompatable form. A Peto odds ratio was calculated where this was appropriate, otherwise a descriptive summary of the results of the individual studies was compiled.
Three eligible studies were found each with small numbers of subjects. They were short term, used single injection sessions with follow-up of between 4 and 26 weeks. One study (Koman), of twelve ambulant children, compared BtA with injection of a placebo and found non-significant improvements in gait in the BtA group compared to the placebo group. Two studies (Corry, Flett) compared BtA with the use of casts. Each included 20 ambulant children and found improvements in gait, range of ankle movement and muscle tone in both the BtA and cast groups. However there were no significant differences between the groups in either trial. One of these trials (Flett) also assessed motor function using the gross motor function measure (GMFM) (Russell, 1989) and found significant improvements in each group compared to baseline but no significant differences between the groups. The other trial (Corry) performed 3D gait analysis on those children able to co-operate. Maximal plantar flexion and maximal dorsiflexion during walking were both found to be significantly greater in the BtA group compared to the cast group. In all other dimensions there were no significant differences between the groups.
REVIEWER'S CONCLUSIONS: This systematic review has not revealed strong controlled evidence to support or refute the use of BtA for the treatment of leg spasticity in cerebral palsy. Ongoing randomised controlled trials are likely to provide useful data on the short term effects of BtA for leg spasticity. Future research should also assess the longer term use of BtA. Ideally studies should be pragmatic in their approach to dose and distribution of toxin to reflect practise. Outcome measures assessing function and disability would give the most useful information.
确定肉毒杆菌毒素（BtA）治疗脑瘫患儿下肢痉挛是否有效且安全。尤其关注功能预后。
通过运动障碍综述小组试验注册库、Cochrane对照试验注册库、MEDLINE、制药公司数据库、与该领域其他研究人员交流以及使用上述检索策略找到的论文参考文献列表，来确定纳入综述的研究。
若研究评估了BtA治疗脑瘫患儿腿部痉挛的疗效，则被认为符合纳入综述的条件。研究必须为随机对照试验，且包括一个接受其他干预措施的同期对照组。
使用论文模板，由两名独立审阅者进行双份提取，从纳入研究中收集数据。两名审阅者分别对每个试验的内部有效性进行评估。由于结果呈现形式不兼容，无法进行荟萃分析。在合适的情况下计算Peto比值比，否则对各研究结果进行描述性总结。
共找到三项符合条件的研究，每项研究的受试者数量都较少。这些研究均为短期研究，采用单次注射，随访时间为4至26周。一项针对12名能行走儿童的研究（科曼研究）将BtA与注射安慰剂进行比较，发现BtA组与安慰剂组相比，步态改善不显著。两项研究（科里研究、弗利特研究）将BtA与使用石膏进行比较。每项研究均纳入20名能行走儿童，发现BtA组和石膏组在步态、踝关节活动范围和肌张力方面均有改善。然而，两项试验中两组之间均无显著差异。其中一项试验（弗利特研究）还使用粗大运动功能测量量表（GMFM）（拉塞尔，1989年）评估运动功能，发现每组与基线相比均有显著改善，但两组之间无显著差异。另一项试验（科里研究）对能够配合的儿童进行了三维步态分析。结果发现，与石膏组相比，BtA组在行走过程中的最大跖屈和最大背屈均显著更大。在所有其他方面，两组之间均无显著差异。
本系统综述未发现有力的对照证据支持或反驳使用BtA治疗脑瘫患儿的腿部痉挛。正在进行的随机对照试验可能会提供关于BtA治疗腿部痉挛短期效果的有用数据。未来的研究还应评估BtA的长期使用情况。理想情况下，研究在毒素剂量和分布方法上应注重实用性，以反映实际应用情况。评估功能和残疾情况的结局指标将提供最有用的信息。
