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A型肉毒毒素注射治疗脑瘫儿童上肢痉挛:随机对照试验的系统评价。

Botulinum Toxin A Injection in Treatment of Upper Limb Spasticity in Children with Cerebral Palsy: A Systematic Review of Randomized Controlled Trials.

机构信息

Department of Physical Medicine and Rehabilitation, National Institute of Neuromuscular Disorders, Cairo, Egypt.

Department of Physical Medicine and Rehabilitation (M.O.M., N.A.E., and A.K.E.) and Division of Pediatric Orthopedics, Department of Orthopedic Surgery (T.A.E.), Ain-Shams University, Cairo, Egypt.

出版信息

JBJS Rev. 2020 Mar;8(3):e0119. doi: 10.2106/JBJS.RVW.19.00119.

Abstract

BACKGROUND

Cerebral palsy (CP) is the most common cause of childhood disability globally. Botulinum toxin A injections are widely used to manage limb spasticity in children with CP. Intramuscular botulinum toxin A has been used in the upper limbs of children with CP to manage preoperative and postoperative pain, facilitate nursing, and achieve functional and/or cosmetic improvement of hand position. These goals are achieved primarily through reduction of spasticity. The aim of this review was to assess the evidence for the effect of botulinum toxin A injections used to manage upper limb spasticity in children with spastic CP. Specifically, we examined the role of botulinum toxin A as an adjunctive treatment to other physical therapy modalities. Additionally, we analyzed the associated complications.

METHODS

The literature extraction process involved 4 phases: identification, screening, eligibility, and inclusion. We used a combination of Google Scholar, PubMed, and ScienceDirect. The choice of the search terms was based on the Medical Subject Headings. We extracted the relevant studies using a combination of words or terms related to (1) patient population, (2) pathology, (3) clinical intervention, and (4) anatomical distribution of pathology. Studies were included if they were randomized controlled trials conducted on children and/or adolescents with CP targeting the upper extremities in which botulinum toxin A was used as an adjunctive treatment to a primary intervention.

RESULTS

The literature extraction process yielded 15 randomized controlled trials for inclusion in this review. The total number of participants enrolled in the included studies was 499, with 255 in the intervention group (51%) and 244 controls (49%). All participants in the eligible studies had unilateral spastic CP except for those in 4 studies (27%) with 198 participants (40%) that included a heterogeneous sample of unilateral and bilateral spastic CP. The mean age of participants in the intervention group ranged from 2.6 to 10.7 years among the individual studies. The mean age of participants in the control group ranged from 3.1 to 10.55 years among the individual studies. This review indicated that botulinum toxin A had a positive effect on the degree of spasticity and cosmetic appearance of the injected upper limb. The results with respect to functional gains and quality of life were either conflicting or not significant.

CONCLUSIONS

Randomized controlled trials of botulinum toxin A injection in the treatment of upper limb spasticity in children with CP used variable outcome measures and yielded mixed results. Overall, there is some evidence to support the use of botulinum toxin A as an adjuvant treatment to other physical therapy regimens or placebo to reduce spasticity in the short term. There is insufficient evidence to support its use as an adjunctive treatment to improve upper limb function or quality of life. The complications were acceptable and did not outweigh the clinical gains incurred.

LEVEL OF EVIDENCE

Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

摘要

背景

脑瘫(CP)是全球儿童残疾的最常见原因。肉毒杆菌毒素 A 注射被广泛用于治疗 CP 儿童的肢体痉挛。肉毒杆菌毒素 A 已被用于 CP 儿童的上肢,以管理术前和术后疼痛,便于护理,并实现手部位置的功能和/或美容改善。这些目标主要通过减少痉挛来实现。本综述的目的是评估肉毒杆菌毒素 A 注射治疗痉挛性 CP 儿童上肢痉挛的疗效证据。具体来说,我们研究了肉毒杆菌毒素 A 作为其他物理治疗方式的辅助治疗的作用。此外,我们分析了相关并发症。

方法

文献提取过程包括 4 个阶段:识别、筛选、合格和纳入。我们使用了 Google Scholar、PubMed 和 ScienceDirect。选择搜索词的依据是医学主题词。我们使用与(1)患者人群、(2)病理学、(3)临床干预和(4)病理学解剖分布相关的词或术语的组合来提取相关研究。如果研究是针对上肢的、针对 CP 儿童和/或青少年的、且将肉毒杆菌毒素 A 作为主要干预的辅助治疗的随机对照试验,则将其纳入本综述。

结果

文献提取过程产生了 15 项随机对照试验,纳入本综述。纳入研究的总参与者人数为 499 人,其中干预组 255 人(51%),对照组 244 人(49%)。除了 4 项研究(27%)中有 198 名参与者(40%)包括单侧和双侧痉挛性 CP 的混合样本外,所有纳入研究的参与者均为单侧痉挛性 CP。干预组参与者的平均年龄在各项研究中为 2.6 至 10.7 岁。对照组参与者的平均年龄在各项研究中为 3.1 至 10.55 岁。本综述表明,肉毒杆菌毒素 A 对注射上肢的痉挛程度和美容外观有积极影响。关于功能获益和生活质量的结果存在冲突或无统计学意义。

结论

CP 儿童上肢痉挛肉毒杆菌毒素 A 注射治疗的随机对照试验使用了不同的结局测量指标,结果不一。总体而言,有一些证据支持将肉毒杆菌毒素 A 作为其他物理治疗方案或安慰剂的辅助治疗,以在短期内减轻痉挛。尚无足够证据支持其作为辅助治疗以改善上肢功能或生活质量。并发症是可以接受的,且没有超过获得的临床获益。

证据水平

治疗性 1 级。请参阅作者说明以获取完整的证据水平描述。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bf22/7161716/60e51f7713f8/jbjsr-8-e0119-g001.jpg

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