Montastruc Jeanne, Marque Philippe, Moulis Florence, Bourg Véronique, Lambert Valérie, Durrieu Geneviève, Montastruc Jean-Louis, Montastruc François
Service de Médecine Physique et de Réadaptation, Centre Hospitalier Universitaire, Toulouse, France.
Service de Pharmacologie Médicale et Clinique, Centre Midi-Pyrénées de Pharmacovigilance, de Pharmacoépidémiologie et d'informations sur le Médicament, CIC INSERM 1436, INSERM U 1027, Faculté de Médecine et Centre Hospitalier Universitaire de Toulouse, Toulouse, France.
Dev Med Child Neurol. 2017 Mar;59(3):329-334. doi: 10.1111/dmcn.13286. Epub 2016 Sep 28.
The aim of this study was to assess the risk of adverse drug reactions (ADRs) with botulinum neurotoxin type A (BoNT-A) in children with cerebral palsy (CP) using the World Health Organization global individual case safety report (ICSR) database, VigiBase.
We extracted all children ICSRs for ADRs with BoNT-A used as anti-spastic drug in CP recorded between 1995 and 2015 in VigiBase. We also performed a case/non-case method (disproportionality analysis) to assess the link between exposure to BoNT-A and each ADR of interest in children and adults, calculating reporting odds ratios (RORs).
In VigiBase, 162 ICSRs were registered. They involved mainly males (n=95, 59%) and mean (SD) age was 7 years 11 months (4y 4mo). The most frequent ADR was dysphagia (27 ICSRs, 17%) followed by asthenia and muscular weakness (25 ICSRs each, 16%). Nineteen ICSRs (12%) were lethal. There was a significant association between BoNT-A and death in children (ROR=11.1 95%, confidence interval [CI] 7.0-17.7) but not in adults.
In children with CP, most ADRs seem to be linked to a systemic spread of BoNT-A. Our study suggests a higher risk of ADRs with BoNT-A in children than in adults.
本研究旨在利用世界卫生组织全球个体病例安全报告（ICSR）数据库VigiBase评估A型肉毒杆菌毒素（BoNT-A）用于脑瘫（CP）患儿时发生药物不良反应（ADR）的风险。
我们从VigiBase中提取了1995年至2015年间记录的所有将BoNT-A用作CP抗痉挛药物的儿童ADR的ICSR。我们还采用病例/非病例方法（不成比例分析）来评估BoNT-A暴露与儿童和成人每种感兴趣的ADR之间的关联，计算报告比值比（ROR）。
在VigiBase中，登记了162份ICSR。主要涉及男性（n = 95，59%），平均（标准差）年龄为7岁11个月（4岁4个月）。最常见的ADR是吞咽困难（27份ICSR，17%），其次是乏力和肌无力（各25份ICSR，16%）。19份ICSR（12%）是致命的。BoNT-A与儿童死亡之间存在显著关联（ROR = 11.1，95%置信区间[CI] 7.0 - 17.7），但在成人中不存在。
在CP患儿中，大多数ADR似乎与BoNT-A的全身扩散有关。我们的研究表明，BoNT-A在儿童中发生ADR的风险高于成人。
