Adverse events after chemodenervation with onabotulinum neurotoxin A in children with hypertonia and sialorrhea.

IF 3.8 2区 医学 Q1 CLINICAL NEUROLOGY Developmental Medicine and Child Neurology Pub Date : 2024-10-21 DOI:10.1111/dmcn.16125
Jacqueline Krieger, Laura Prosser, Sarah Helen Evans
{"title":"Adverse events after chemodenervation with onabotulinum neurotoxin A in children with hypertonia and sialorrhea.","authors":"Jacqueline Krieger, Laura Prosser, Sarah Helen Evans","doi":"10.1111/dmcn.16125","DOIUrl":null,"url":null,"abstract":"<p><strong>Aim: </strong>To identify the incidence and type of adverse events reported after chemodenervation with onabotulinum neurotoxin A (BoNT-A) in children with hypertonia and sialorrhea and compare adverse events in the on-label or off-label use of BoNT-A with regard to dose, patient's age, and location of the injection.</p><p><strong>Method: </strong>Using a retrospective chart review, we studied BoNT-A injections occurring from January 2017 to December 2020 in patients at a pediatric hospital. The electronic health record was examined to identify adverse events reported within 2 months of the injection. Data included the patient's age, sex, race, and ethnicity, as well as the type of toxin injected, the dose, the location of injection, and the patient's weight.</p><p><strong>Results: </strong>We analyzed 1733 procedures. Adverse events were infrequent (2.5%) and not serious, most commonly reported as pain or discomfort. All adverse events were temporary and there were no deaths. We did not observe a meaningful difference in the frequency of adverse events for injections that exceeded the 2022 US Food and Drug Administration (FDA)-approved maximum dose compared to injections that were within the FDA-approved dose range. The likelihood of adverse events did not increase with higher doses of BoNT-A. More adverse events were reported for injection into the salivary glands (4.37%) than into the extremities (2.26%).</p><p><strong>Interpretation: </strong>Higher doses of injected BoNT-A in a pediatric population may be safe. Further work is needed to investigate the relationship between dose and efficacy.</p>","PeriodicalId":50587,"journal":{"name":"Developmental Medicine and Child Neurology","volume":" ","pages":""},"PeriodicalIF":3.8000,"publicationDate":"2024-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Developmental Medicine and Child Neurology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1111/dmcn.16125","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
引用次数: 0

Abstract

Aim: To identify the incidence and type of adverse events reported after chemodenervation with onabotulinum neurotoxin A (BoNT-A) in children with hypertonia and sialorrhea and compare adverse events in the on-label or off-label use of BoNT-A with regard to dose, patient's age, and location of the injection.

Method: Using a retrospective chart review, we studied BoNT-A injections occurring from January 2017 to December 2020 in patients at a pediatric hospital. The electronic health record was examined to identify adverse events reported within 2 months of the injection. Data included the patient's age, sex, race, and ethnicity, as well as the type of toxin injected, the dose, the location of injection, and the patient's weight.

Results: We analyzed 1733 procedures. Adverse events were infrequent (2.5%) and not serious, most commonly reported as pain or discomfort. All adverse events were temporary and there were no deaths. We did not observe a meaningful difference in the frequency of adverse events for injections that exceeded the 2022 US Food and Drug Administration (FDA)-approved maximum dose compared to injections that were within the FDA-approved dose range. The likelihood of adverse events did not increase with higher doses of BoNT-A. More adverse events were reported for injection into the salivary glands (4.37%) than into the extremities (2.26%).

Interpretation: Higher doses of injected BoNT-A in a pediatric population may be safe. Further work is needed to investigate the relationship between dose and efficacy.

查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
在患有肌张力亢进和巩膜下垂的儿童中使用奥那布林神经毒素 A 进行化学神经支配后出现的不良事件。
摘要:目的:确定在患有肌张力亢进和霰粒肿的儿童中使用奥那布宁神经毒素A(BoNT-A)进行化学神经支配后报告的不良事件的发生率和类型,并比较在标签内或标签外使用BoNT-A的不良事件与剂量、患者年龄和注射位置的关系:通过回顾性病历审查,我们对一家儿科医院 2017 年 1 月至 2020 年 12 月期间发生的 BoNT-A 注射进行了研究。我们对电子病历进行了检查,以确定注射后 2 个月内报告的不良事件。数据包括患者的年龄、性别、种族和民族,以及注射毒素的类型、剂量、注射位置和患者体重:我们分析了 1733 例手术。不良反应并不常见(2.5%),也不严重,最常见的是疼痛或不适。所有不良反应都是暂时的,没有死亡病例。我们没有观察到超过 2022 年美国食品和药物管理局 (FDA) 批准的最大剂量的注射与 FDA 批准的剂量范围内的注射在不良事件发生频率上存在有意义的差异。发生不良事件的可能性并没有随着 BoNT-A 剂量的增加而增加。注射到唾液腺(4.37%)比注射到四肢(2.26%)发生的不良反应更多:在儿科人群中注射较高剂量的 BoNT-A 可能是安全的。需要进一步研究剂量与疗效之间的关系。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 去求助
来源期刊
CiteScore
7.80
自引率
13.20%
发文量
338
审稿时长
3-6 weeks
期刊介绍: Wiley-Blackwell is pleased to publish Developmental Medicine & Child Neurology (DMCN), a Mac Keith Press publication and official journal of the American Academy for Cerebral Palsy and Developmental Medicine (AACPDM) and the British Paediatric Neurology Association (BPNA). For over 50 years, DMCN has defined the field of paediatric neurology and neurodisability and is one of the world’s leading journals in the whole field of paediatrics. DMCN disseminates a range of information worldwide to improve the lives of disabled children and their families. The high quality of published articles is maintained by expert review, including independent statistical assessment, before acceptance.
期刊最新文献
Longitudinal relationship between hip displacement and hip function in children and adolescents with cerebral palsy: A scoping review. Neuroprotection for neonatal hypoxic-ischemic encephalopathy: A review of novel therapies evaluated in clinical studies. Experiences of caregivers of children with severe self-injurious behavior: An interpretive, descriptive study. Effect of selective dorsal rhizotomy on neuromuscular symptoms, muscle morphology, and motor function in children with spastic cerebral palsy. Informed consent in assisted reproductive technology: Implications for pediatric clinicians.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1