A型肉毒毒素局部注射治疗儿童痉挛型脑瘫马蹄足畸形有效性及安全性的Meta分析

Efficacy and safety of botulinum toxin A injection for the spastic equinus foot in children with cerebral palsy：a meta-analysis

摘要:

目的：通过分析国内外相关文献，系统评价A型肉毒毒素局部注射治疗儿童痉挛型脑瘫马蹄足畸形的有效性及安全性。方法：参考Cochrane协作网制定的随机对照试验（randomized controlled trials，RCTs）检索策略，计算机检索Cochrane Li－brary、Medline、PubMed、中国期刊全文数据库、万方数据库等中英文数据库，以及手工检索相关期刊、会议论文汇编中所有关于A型肉毒毒素局部注射治疗儿童痉挛型脑瘫马蹄足畸形疗效的临床对照研究。对纳入研究进行质量评价，采用RevMan 5.3进行Meta分析的相关计算。结果：共纳入7项研究，患者共576例，A型肉毒毒素组360例，安慰剂组216例。A型肉毒毒素与安慰剂局部注射治疗儿童痉挛型脑瘫马蹄足畸形比较，不良事件发生率（RR=1.40，95%CI=0.99～1.97，P=0.060）无统计学差异，在步态分析（RR=2.29，95%CI=1.56～3.37，P=0.000）、主动状态下肌肉痉挛程度（MD=8.76，95%CI=5.86～11.66，P=0.000）、被动状态下肌肉痉挛程度（MD=4.88，95%CI=0.96～8.80，P=0.010）、生活质量变化（RR=1.49，95%CI=1.08～2.06，P=0.020）上差异有统计学意义。结论：A型肉毒毒素局部注射是治疗儿童痉挛型脑瘫马蹄足畸形安全有效的方法，值得在临床上推广。

Abstract:

Objective：To systematically review the efficacy and safety of botulinum toxin A injection for the spastic equinus foot in children with cerebral palsy by analyzing the domestic and foreign relevant literature. Methods：All relevant controlled clinical re－searches（randomized controlled trials，RCTs） about the efficacy and safety of botulinum toxin A injection for the spastic equinus foot in children with cerebral palsy from Cochrane Collaboration，Cochrane Library，Medline，PubMed，Chinese periodical full-text database，Wanfang Standards Database and other Chinese and English database were searched，as well as the relevant literatures and confer－ence proceedings. Quality of enrolled literatures was assessed；Meta analysis calculations are made by ReyMan 5.3. Results：A total of seven studies with a total of 576 cases were enrolled including 360 cases of botulinum toxin A and 216 cases of placebo. There was no significant differences in the incidence of adverse events（RR=1.40，95%CI=0.99 to 1.97，P=0.06） between botulinum toxin A and placebo in the treatment of the spastic equinus foot in cerebral palsy. In the gait analysis（RR=2.29，95%CI=1.56 to 3.37，P＝0.000），There were significant differences in the degree of dynamic muscle spasm（MD=8.76，95%CI=5.86 to 11.66，P＝0.000），the degree of arrest muscle spasm（MD=4.88，95%CI=0.96 to 8.80，P=0.01），quality of life change difference（RR=1.49，95%CI=1.08 to 2.06，P=0.02） between two groups. Conclusion：Botulinum toxin A in－jection for the spastic equinus foot in children with cerebral palsy is safe and effective. Therefore，it is worth promoting and applying in clinic.