van Hulst Karen, Kouwenberg Carlyn V, Jongerius Pieter H, Feuth Ton, van den Hoogen Franciscus J A, Geurts Alexander C H, Erasmus Corrie E
Department of Rehabilitation, Donders Centre for Neuroscience, Radboud University Medical Centre, Nijmegen, The Netherlands.
Department of Neurology, Donders Centre for Neuroscience, Radboud University Medical Centre, Nijmegen, The Netherlands.
Dev Med Child Neurol. 2017 May;59(5):531-537. doi: 10.1111/dmcn.13333. Epub 2016 Nov 30.
The aims of this study were: (1) to determine the incidence and nature of adverse effects on oral motor function after first injections of botulinum neurotoxin A (BoNT-A) in submandibular glands for excessive drooling in children with central nervous system disorders; and (2) to identify independent predictors of these adverse effects.
A cohort study involved 209 children (123 males, 86 females, aged 4-27y, median 8y 4mo), who received submandibular BoNT-A injections for drooling. Adverse effects were categorized into swallowing, eating, drinking, articulation, and other problems. Univariable logistic regression was used to study differences in patients with and without adverse effects. Possible predictors were identified using multivariable logistic regression.
Transient adverse effects occurred in 33% of the 209 BoNT-A treatments. Almost 80% of these were mild, versus 8.7% severe. Approximately 54% of the adverse effects spontaneously resolved within 4 weeks; 3% still existed after 32 weeks. A diagnosis of cerebral palsy, higher range of BoNT-A dosage, and a pre-treatment drooling quotient <18% were found to be independent predictors of adverse effects.
Before using submandibular BoNT-A injections for drooling, potential adverse effects should be discussed. Oral motor function needs to be monitored, because existing dysphagia may be worsened. The identified clinical predictors could be helpful to optimize patient selection.
本研究的目的是：（1）确定首次注射肉毒杆菌神经毒素A（BoNT-A）治疗中枢神经系统疾病患儿下颌下腺流涎过多后对口腔运动功能产生不良反应的发生率和性质；（2）确定这些不良反应的独立预测因素。
一项队列研究纳入了209名儿童（123名男性，86名女性，年龄4-27岁，中位数8岁4个月），他们接受了下颌下BoNT-A注射治疗流涎。不良反应分为吞咽、进食、饮水、发音及其他问题。采用单变量逻辑回归研究有无不良反应患者之间的差异。通过多变量逻辑回归确定可能的预测因素。
在209次BoNT-A治疗中，33%出现了短暂的不良反应。其中近80%为轻度，重度占8.7%。约54%的不良反应在4周内自行缓解；32周后仍有3%存在。脑瘫诊断、较高剂量的BoNT-A以及治疗前流涎商<18%被发现是不良反应的独立预测因素。
在使用下颌下BoNT-A注射治疗流涎之前，应讨论潜在的不良反应。需要监测口腔运动功能，因为现有的吞咽困难可能会加重。确定的临床预测因素有助于优化患者选择。
