Neurodevelopmental Effects of Antiepileptic Drugs II

抗癫痫药物对神经发育的影响 II

• 批准号: 7118472
• 负责人: KIMFORD J MEADOR
• 金额: $ 5.26万
• 依托单位: UNIVERSITY OF FLORIDA
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-09-30 至 2010-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7118472
• 关键词: clinical research

The proposed investigation is a continuation of the ongoing NEAD study, which addresses an important health care issue for women and their children. The use of antiepileptic drugs (AEDs) in women of childbearing age for epilepsy and for other indications (e.g., pain and psychiatric disorders) is common, but physicians need additional data, which are critical to adequately advise and direct treatment in these women. Animal studies have clearly demonstrated that commonly employed AEDs impair behavioral neurodevelopment. The potential consequences of such cognitive and behavioral deficits in humans are severe in terms of both personal and societal costs. However, controversy exists on the following issue to be addressed by this proposal. Do the most commonly used AEDs have differential effects on neurobehavioral outcomes in children exposed in utero? The primary objective of this study is to differentiate the relative risks/benefits of the four most commonly used AEDs in the treatment of women with epilepsy in terms of their children's neurobehavioral development after in utero exposure to AED monotherapy (carbamazepine, lamotrigine, phenytoin, or valproate). The NEAD study is a prospective, parallel-group, cohort design, multicenter investigation. The major strength of the NEAD study is that it has enrolled a large and unique cohort of 323 mother/child pairs during pregnancy and collected prospective data on factors, which could affect neurobehavioral outcome. The primary outcome variables are IQ scores of the children and other measures of neurobehavioral development at 6 years/old. This grant extension is designed to follow the children to 6 years/old at which time neurobehavioral measures predict school performance and ultimate adult IQ. Samples have and will be collected for future pharmacogenetic investigations. The NEAD study has an invaluable cohort, and the results of this continuation proposal will impact the clinical management of women receiving these medications, and improve the health of their children.

拟议的调查是正在进行的NEAD研究的延续，该研究解决了妇女及其子女的一个重要保健问题。育龄妇女使用抗癫痫药物治疗癫痫和其他适应症（如疼痛和精神疾病）的情况很常见，但医生需要额外的数据，这对于充分建议和指导这些妇女的治疗至关重要。动物研究清楚地表明，常用的aed会损害行为神经发育。就个人和社会成本而言，人类这种认知和行为缺陷的潜在后果是严重的。然而，在该提案要解决的以下问题上存在争议。最常用的aed对子宫内接触的儿童的神经行为结果有不同的影响吗？本研究的主要目的是根据子宫内暴露于AED单药治疗（卡马西平、拉莫三嗪、苯妥英或丙戊酸）后儿童神经行为发育，区分四种最常用的AED治疗女性癫痫患者的相对风险/益处。NEAD研究是一项前瞻性、平行组、队列设计、多中心调查。NEAD研究的主要优势在于，它招募了一个庞大而独特的323对怀孕期间的母亲/孩子，并收集了可能影响神经行为结果的因素的前瞻性数据。主要的结果变量是儿童的智商分数和6岁时神经行为发展的其他指标。这项延长拨款的目的是跟踪儿童到6岁，在这个时候，神经行为测量可以预测学校表现和最终的成人智商。样本已经收集并将用于未来的药理学研究。NEAD研究有一个非常宝贵的队列，这一继续建议的结果将影响接受这些药物的妇女的临床管理，并改善其子女的健康。