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肉毒杆菌毒素A治疗脑性瘫痪患儿内收肌痉挛:一项随机、双盲、安慰剂对照研究

Treatment of adductor spasticity with BTX-A in children with CP: a randomized, double-blind, placebo-controlled study.

作者信息

Mall Volker, Heinen Florian, Siebel Andrea, Bertram Christoph, Hafkemeyer Ulrich, Wissel Jörg, Berweck Steffen, Haverkamp Fritz, Nass Günter, Döderlein Leo, Breitbach-Faller Nico, Schulte-Mattler Wilhelm, Korinthenberg Rudolf

机构信息

Children's University Hospital, Freiburg University, Germany.

出版信息

Dev Med Child Neurol. 2006 Jan;48(1):10-3. doi: 10.1017/S0012162206000041.

DOI:10.1017/S0012162206000041
PMID:16359588
Abstract

Adductor spasticity in children with cerebral palsy (CP) impairs motor function and development. In a placebo-controlled, double-blind, randomized multicentre study, we evaluated the effects of botulinum toxin A(BTX-A) in 61 children (37 males, 24 females; mean age 6 years 1 month [SD 3y 1mo]) with CP (leg-dominated tetraparesis, n=39; tetraparesis, n=22; GMFCS level I, n=3; II, n=6; III, n=17; IV, n=29; V, n=6). Four weeks after treatment, a significant superiority of BTX-A was observed in the primary outcome measure (knee-knee distance 'fast catch', p=0.002), the Ashworth scale (p=0.001), and the Goal Attainment Scale (p=0.037).

摘要

脑性瘫痪(CP)患儿的内收肌痉挛会损害运动功能和发育。在一项安慰剂对照、双盲、随机多中心研究中,我们评估了A型肉毒毒素(BTX-A)对61例CP患儿(男37例,女24例;平均年龄6岁1个月[标准差3岁1个月])的疗效,这些患儿的CP类型为:以腿部为主的四肢轻瘫,n = 39;四肢轻瘫,n = 22;粗大运动功能分级系统(GMFCS)I级,n = 3;II级,n = 6;III级,n = 17;IV级,n = 29;V级,n = 6。治疗四周后,在主要结局指标(膝-膝距离“快速捕捉”,p = 0.002)、Ashworth量表(p = 0.001)和目标达成量表(p = 0.037)方面,观察到BTX-A具有显著优势。

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