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A型肉毒毒素联合支具能否预防脑瘫且“髋关节有风险”儿童的髋关节移位?一项随机对照试验。

Does botulinum toxin a combined with bracing prevent hip displacement in children with cerebral palsy and "hips at risk"? A randomized, controlled trial.

作者信息

Graham H Kerr, Boyd Roslyn, Carlin John B, Dobson Fiona, Lowe Kevin, Nattrass Gary, Thomason Pam, Wolfe Rory, Reddihough Dinah

机构信息

Departments of Orthopaedics, The Royal Children's Hospital, Flemington Road, Parkville, Victoria 3052, Australia.

出版信息

J Bone Joint Surg Am. 2008 Jan;90(1):23-33. doi: 10.2106/JBJS.F.01416.

Abstract

BACKGROUND

Cerebral palsy is the most common cause of childhood physical disability in developed countries, affecting two children per 1000 live births. Hip displacement affects about one-third of children with cerebral palsy and may result in pain, deformity, and impaired function. The prevention of hip displacement has not been studied in a randomized trial as far as we know.

METHODS

A randomized, controlled trial was conducted to examine the effect of intramuscular injections of botulinum toxin A combined with use of a variable hip abduction brace on the progression of hip displacement in children with cerebral palsy. The patients in the treatment group received injections of botulinum toxin A to the adductor and hamstring muscles every six months for three years and were prescribed a hip abduction brace to be worn for six hours per day. In the control group, no hip bracing was used nor were injections performed. The primary outcome measure was hip displacement from the acetabulum as determined by serial measurements of the migration percentage.

RESULTS

Ninety children with bilateral cerebral palsy and so-called hips at risk (a migration percentage of >10% but <40%) were entered into the study. Fifty-nine patients were boys, and the mean age was three years. Progressive hip displacement, as determined by serial measurements of the migration percentage, was found in both the treatment and control groups. The rate of hip displacement was reduced in the treatment group by 1.4% per year (95% confidence interval, -0.6% to 3.4%; p = 0.16) when weighted for the uncertainty in rates due to the differing numbers of migration percentage measurements per subject.

CONCLUSIONS

There may be a small treatment benefit for the combined intervention of intramuscular injection of botulinum toxin A and abduction hip bracing in the management of spastic hip displacement in children with cerebral palsy. However, progressive hip displacement continued to occur in the treatment group, and our data do not support recommending this treatment.

摘要

背景

在发达国家,脑瘫是儿童身体残疾的最常见原因,每1000例活产中有两名儿童受影响。髋关节脱位影响约三分之一的脑瘫儿童,可能导致疼痛、畸形和功能受损。据我们所知,尚未在随机试验中研究髋关节脱位的预防。

方法

进行了一项随机对照试验,以检查肌肉注射A型肉毒杆菌毒素联合使用可变髋关节外展支具对脑瘫儿童髋关节脱位进展的影响。治疗组患者每六个月向内收肌和腘绳肌注射一次A型肉毒杆菌毒素,持续三年,并开具髋关节外展支具,每天佩戴六小时。对照组未使用髋关节支具,也未进行注射。主要结局指标是通过连续测量迁移百分比确定的髋关节相对于髋臼的脱位情况。

结果

90名双侧脑瘫且髋关节有风险(迁移百分比>10%但<40%)的儿童进入研究。59名患者为男孩,平均年龄为3岁。通过连续测量迁移百分比确定,治疗组和对照组均出现了进行性髋关节脱位。在考虑到由于每个受试者迁移百分比测量次数不同导致的率的不确定性进行加权后,治疗组髋关节脱位率每年降低1.4%(95%置信区间,-0.6%至3.4%;p = 0.16)。

结论

对于脑瘫儿童痉挛性髋关节脱位的治疗,肌肉注射A型肉毒杆菌毒素和外展髋关节支具的联合干预可能有小的治疗益处。然而,治疗组仍继续出现进行性髋关节脱位,我们的数据不支持推荐这种治疗方法。

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