| アブストラクト | AIM: 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. METHOD: 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). RESULTS: 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. INTERPRETATION: 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. |
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| ジャーナル名 | Developmental medicine and child neurology |
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| 投稿日 | 2016/09/30 |
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| 投稿者 | Montastruc, Jeanne; Marque, Philippe; Moulis, Florence; Bourg, Veronique; Lambert, Valerie; Durrieu, Genevieve; Montastruc, Jean-Louis; Montastruc, Francois |
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| 組織名 | Service de Medecine Physique et de Readaptation, Centre Hospitalier;Universitaire, Toulouse, France.;Service de Pharmacologie Medicale et Clinique, Centre Midi-Pyrenees de;Pharmacovigilance, de Pharmacoepidemiologie et d'informations sur le Medicament,;CIC INSERM 1436, INSERM U 1027, Faculte de Medecine et Centre Hospitalier;Universitaire de Toulouse, Toulouse, France.;Centre Paul Dottin ASEI, Soins de suite et de readaptation pediatriques;specialises, Toulouse, France. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/27682175/ |
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