肉毒毒素治疗脑瘫儿童上肢痉挛的短期、中期和长期效果：随机对照试验的荟萃分析。
Short- medium- and long-term effects of botulinum toxin on upper limb spasticity in children with cerebral palsy: A meta-analysis of randomized controlled trials.
机构信息
Department of Rehabilitation, Guangzhou Women and Children's Medical Centre, Guangzhou Medical University, No. 318 Renmin Middle Road, Guangzhou, 510120, China; Guangdong Provincial Clinical Research Center for Child Health, No. 9 Jinsui Road, Guangzhou, 510623, China.
Department of Rehabilitation, Guangzhou Women and Children's Medical Centre, Guangzhou Medical University, No. 318 Renmin Middle Road, Guangzhou, 510120, China; Guangdong Provincial Clinical Research Center for Child Health, No. 9 Jinsui Road, Guangzhou, 510623, China.
出版信息
Ann Phys Rehabil Med. 2024 Oct;67(7):101869. doi: 10.1016/j.rehab.2024.101869. Epub 2024 Aug 23.
BACKGROUND
Botulinum toxin (BTX) is an effective management method for spasticity in children with cerebral palsy (CP), but the short- medium- and long-term effects remain unclear.
OBJECTIVE
The primary objective was to quantify the effects of BTX injections on upper limb spasticity over time in children with CP. The secondary objective was to evaluate efficacy according to the International Classification of Functioning, Disability, and Health-Children & Youth version framework.
METHODS
We conducted a systematic review and meta-analysis of randomized controlled trials that included control/comparison groups treated with a placebo or other treatments. We searched CINAHL, Embase, PubMed, Scopus, Web of Science, and PsycINFO from their inception to April 2024. The pooled mean difference (MD) or standard mean difference (SMD) with 95 % CI was calculated using a random effects model at the short-term (up to 3 months), medium-term (3 to 6 months), and long-term (over 6 months).
RESULTS
A total of 658 children with CP aged 1.8 to 19 years old in 12 eligible trials were involved. The primary outcome of the Melbourne Assessment percentile showed a significant increase in the medium- (MD = 2.63, 95 % CI 0.22 to 5.04, I² = 0 %) and long-term (MD = 4.72, 95 % CI 0.93 to 8.51, I² = 0 %) in favor of BTX. Pooled effects also showed that BTX significantly improved Modified Ashworth Scale scores in the short- (MD = -0.44, 95 % CI -0.88 to -0.01, I² = 88 %) and medium-term (MD = -0.20, 95 % CI -0.28 to -0.13, I² = 0 %), and individual goals and bimanual performance up to 6-months. No significantly higher risk of adverse events was observed with BTX.
CONCLUSIONS AND IMPLICATIONS
BTX injections sustainably improved the quality of affected upper limb function and temporarily improved individual goals and bimanual performance in children with CP. Our findings cautiously support a time interval of 3 to 6 months between BTX injections in the upper limbs of children with CP.
TRIAL REGISTRATION
This study was registered in the International Prospective Register of Systematic Reviews (PROSPERO) (Registration ID: CRD42022323672).
背景
肉毒毒素（BTX）是治疗脑瘫（CP）儿童痉挛的有效方法，但短期、中期和长期效果仍不清楚。
目的
主要目的是量化 BTX 注射对 CP 儿童上肢痉挛的随时间变化的影响。次要目的是根据国际功能、残疾和健康分类-儿童与青少年版框架评估疗效。
方法
我们对包括安慰剂或其他治疗的对照/比较组的随机对照试验进行了系统评价和荟萃分析。我们从其开始到 2024 年 4 月在 CINAHL、Embase、PubMed、Scopus、Web of Science 和 PsycINFO 进行了搜索。使用随机效应模型计算短期（最长 3 个月）、中期（3 至 6 个月）和长期（超过 6 个月）的汇总均数差（MD）或标准均数差（SMD）及 95 % CI。
结果
共有 12 项合格试验中 658 名年龄在 1.8 至 19 岁的 CP 儿童参与。墨尔本评估百分位数的主要结局显示，BTX 在中期（MD=2.63，95 % CI 0.22 至 5.04，I²=0 %）和长期（MD=4.72，95 % CI 0.93 至 8.51，I²=0 %）均有显著增加，有利于 BTX。汇总效应还表明，BTX 可显著改善短期（MD=-0.44，95 % CI-0.88 至-0.01，I²=88 %）和中期（MD=-0.20，95 % CI-0.28 至-0.13，I²=0 %）的改良 Ashworth 量表评分，以及 6 个月内的个体目标和双手表现。未观察到 BTX 治疗的不良反应风险显著增加。
结论和意义
BTX 注射可持续改善受影响上肢功能的质量，并暂时改善 CP 儿童的个体目标和双手表现。我们的研究结果谨慎地支持 CP 儿童上肢 BTX 注射的时间间隔为 3 至 6 个月。
试验注册
本研究已在国际前瞻性系统评价注册库（PROSPERO）（注册号：CRD42022323672）注册。
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