英国儿童抗癫痫药物不良反应前瞻性观察研究方案
Protocol for a prospective observational study of adverse drug reactions of anti-epileptic drugs in children in the UK.
作者信息
Egunsola Oluwaseun, Sammons Helen M, Ojha Shalini, Whitehouse William, Anderson Mark, Hawcutt Dan, Choonara Imti
机构信息
Department of Child Health, School of Medicine, University of Nottingham, Derby, UK.
Department of Paediatrics, North Devon District Hospital, Nottingham, UK.
出版信息
BMJ Paediatr Open. 2017 Aug 4;1(1):e000116. doi: 10.1136/bmjpo-2017-000116. eCollection 2017.
BACKGROUND
Epilepsy is a common chronic disease of children that can be treated with anti-epileptic drugs (AEDs). AEDs, however, have significant side effects. Newer AEDs are thought to have fewer side effects. There have, however, been few comparative studies of AED toxicity. The aim is to compare the safety profile of the most frequently used AEDs by performing a multicentre prospective cohort study. This protocol describes the planned study.
DESIGN
A multicentre prospective cohort study of children on AED treatment in hospitals across the UK. Ethical approval will be obtained.
SAMPLE SIZE
Three thousand children on treatment for epilepsy will be recruited from paediatric clinics. It is expected that this sample size will have the potential to compare toxicity between the most frequently used AEDs.
DURATION OF STUDY
24 months.
OUTCOME MEASURE
Adverse drug reactions (ADRs) to AEDs. These will be identified by the use of a validated questionnaire, the Paediatric Epilepsy Side Effect Questionnaire. They will be evaluated using the Naranjo algorithm. Preventability will be assessed using the Schumock and Thornton scale.
DISCUSSION
Toxicity of individual AEDs when given as monotherapy and polytherapy will be determined. Additionally, discontinuation rates due to ADRs will be determined. The data will assist clinicians in choosing AEDs with the least toxicity.
背景
癫痫是一种常见的儿童慢性疾病，可用抗癫痫药物（AEDs）进行治疗。然而，AEDs具有显著的副作用。人们认为新型AEDs的副作用较少。然而，关于AEDs毒性的比较研究却很少。目的是通过开展一项多中心前瞻性队列研究，比较最常用AEDs的安全性。本方案描述了计划开展的研究。
设计
对英国各地医院接受AED治疗的儿童进行一项多中心前瞻性队列研究。将获得伦理批准。
样本量
将从儿科诊所招募3000名接受癫痫治疗的儿童。预计这个样本量有潜力比较最常用AEDs之间的毒性。
研究时长
24个月。
观察指标
对AEDs的药物不良反应（ADRs）。这些将通过使用经过验证的问卷《儿科癫痫副作用问卷》来确定。将使用纳朗霍算法对其进行评估。可预防性将使用舒莫克和桑顿量表进行评估。
讨论
将确定单一疗法和联合疗法使用时各AEDs的毒性。此外，还将确定因ADRs导致的停药率。这些数据将帮助临床医生选择毒性最小的AEDs。
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