University of Sydney, Sydney, NSW, Australia.
The Children's Hospital at Westmead, Westmead, NSW, Australia.
Dev Med Child Neurol. 2018 May;60(5):498-504. doi: 10.1111/dmcn.13686. Epub 2018 Feb 16.
To determine the incidence of common adverse events after botulinum toxin A (BoNT-A) injections in children with cerebral palsy (CP) and to identify whether the severity of CP influences the incidence of adverse events.
This was an observational study of patients attending a BoNT-A clinic at a tertiary paediatric hospital (2010-2014). Data examined included procedural adverse events at the time of injection and at follow-up. Systemic adverse events were defined as lower respiratory tract illnesses, generalized weakness, dysphagia, and death. Severity of CP was categorized by the Gross Motor Function Classification System (GMFCS). The relationships between GMFCS and adverse events were analysed using negative binomial regression models.
In total, 591 children underwent 2219 injection episodes. Adverse events were reported during the procedure (130 [6%] injection episodes) and at follow-up (492 [22%] injection episodes). There were significantly increased rates of systemic adverse events in injection episodes involving children in GMFCS level IV (incidence rate ratio [IRR] 3.92 [95% confidence interval] 1.45-10.57]) and GMFCS level V (IRR 7.37 [95% confidence interval 2.90-18.73]; p<0.001).
Adverse events after BoNT-A injections are common but mostly mild and self-limiting. Children in GMFCS levels IV and V are at increased risk of systemic adverse events. The relationship between CP severity and BoNT-A adverse events is complex and further research is required to better understand this relationship.
Adverse events reported at the time of botulinum toxin A injection occurred in 6% of injection episodes. Adverse events were reported at follow-up in 22% of injection episodes. Children in Gross Motor Function Classification System (GMFCS) levels IV and V have increased rates of systemic adverse events. Children in GMFCS levels IV and V report less local weakness and pain.
确定脑瘫(CP)患儿接受肉毒毒素 A(BoNT-A)注射后的常见不良反应发生率,并确定 CP 严重程度是否影响不良反应发生率。
这是一项在一家三级儿科医院的 BoNT-A 诊所进行的观察性研究(2010-2014 年)。检查的数据包括注射时和随访时的程序不良反应。全身性不良反应定义为下呼吸道疾病、全身无力、吞咽困难和死亡。CP 严重程度通过粗大运动功能分类系统(GMFCS)进行分类。使用负二项回归模型分析 GMFCS 与不良反应之间的关系。
共有 591 名儿童进行了 2219 次注射。在注射过程中和随访期间报告了不良反应(130[6%]次注射,492[22%]次注射)。GMFCS 水平 IV(发病率比 [IRR]3.92[95%置信区间 1.45-10.57])和 GMFCS 水平 V(IRR7.37[95%置信区间 2.90-18.73])的儿童注射后全身不良反应发生率显著增加(p<0.001)。
BoNT-A 注射后不良反应常见,但大多为轻度和自限性。GMFCS 水平 IV 和 V 的儿童发生全身性不良反应的风险增加。CP 严重程度与 BoNT-A 不良反应之间的关系很复杂,需要进一步研究以更好地理解这种关系。
注射时报告的不良反应发生在 6%的注射事件中。在注射后的随访中,有 22%的注射事件报告了不良反应。GMFCS 水平 IV 和 V 的儿童发生全身性不良反应的发生率较高。GMFCS 水平 IV 和 V 的儿童报告的局部无力和疼痛较少。