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唾液腺肉毒毒素注射治疗脑瘫和神经发育障碍儿童流涎:系统评价。

Salivary gland botulinum toxin injections for drooling in children with cerebral palsy and neurodevelopmental disability: a systematic review.

机构信息

Queensland Paediatric Rehabilitation Service, The Royal Children's Hospital, Herston, Brisbane, Australia.

出版信息

Dev Med Child Neurol. 2012 Nov;54(11):977-87. doi: 10.1111/j.1469-8749.2012.04370.x. Epub 2012 Sep 5.

Abstract

AIM

The aim of this paper was to systematically review the efficacy and safety of botulinum toxin (BoNT) injections to the salivary glands to treat drooling in children with cerebral palsy and neurodevelopmental disability.

METHOD

A systematic search of The Cochrane Central Register of Controlled Trials, PubMed, CINAHL (Cumulative Index to Nursing and Allied Health Literature), EMBASE, and the Physiotherapy Evidence Database (PEDro) was conducted (up to 1 October 2011). Data sources included published randomized controlled trials (RCTs) and prospective studies.

RESULTS

Sixteen studies met inclusion criteria. Three outcome measures support the effectiveness of BoNT for drooling. One RCT found an almost 30% reduction in the impact of drooling on patients' lives, as measured by the Drooling Impact Scale (mean difference -27.45; 95% confidence interval [CI] -35.28 to -19.62). There were sufficient data to pool results on one outcome measure, the Drooling Frequency and Severity Scale, which supports this result (mean difference -2.71; 95% CI -4.82 to -0.60; p<0.001). There was a significant reduction in the observed number of bibs required per day. The incidence of adverse events ranged from 2 to 41%, but was inconsistently reported. One trial was terminated early because of adverse events.

INTERPRETATION

BoNT is an effective, temporary treatment for sialorrhoea in children with cerebral palsy. Benefits need to be weighed against the potential for serious adverse events. More studies are needed to address the safety of BoNT and to compare BoNT with other treatment options for drooling.

摘要

目的

本文旨在系统评价肉毒毒素(BoNT)注射治疗脑瘫和神经发育障碍儿童流涎的疗效和安全性。

方法

对 Cochrane 中央对照试验注册库、PubMed、CINAHL(护理与联合健康文献累积索引)、EMBASE 和物理治疗证据数据库(PEDro)进行了系统检索(截至 2011 年 10 月 1 日)。资料来源包括已发表的随机对照试验(RCT)和前瞻性研究。

结果

16 项研究符合纳入标准。有 3 项结局指标支持 BoNT 治疗流涎的有效性。1 项 RCT 发现,使用流涎影响量表(Drooling Impact Scale)衡量,患者的流涎对生活的影响几乎降低了 30%(平均差值-27.45;95%置信区间 [CI] -35.28 至-19.62)。有足够的数据对 1 项结局指标,即流涎频率和严重程度量表(Drooling Frequency and Severity Scale)的结果进行汇总,结果支持这一结论(平均差值-2.71;95% CI -4.82 至-0.60;p<0.001)。观察到的每日所需围嘴数量明显减少。不良事件的发生率为 2%至 41%,但报告不一致。有 1 项试验因不良事件而提前终止。

结论

BoNT 是脑瘫儿童流涎的一种有效、暂时的治疗方法。需要权衡益处与潜在的严重不良事件。需要更多的研究来解决 BoNT 的安全性问题,并比较 BoNT 与其他流涎治疗选择。

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