Le Bonheur Children's Hospital, University of Tennessee Health Science Center, Memphis, Tennessee, USA.
New York University Grossman School of Medicine, New York, New York, USA.
Epilepsia. 2022 Sep;63 Suppl 1(Suppl 1):S55-S68. doi: 10.1111/epi.17363.
Clinical studies of rescue medications for seizure clusters are limited and are designed to satisfy regulatory requirements, which may not fully consider the needs of the diverse patient population that experiences seizure clusters or utilize rescue medication. The purpose of this narrative review is to examine the factors that contribute to, or may influence the quality of, seizure cluster research with a goal of improving clinical practice. We address five areas of unmet needs and provide advice for how they could enhance future trials of seizure cluster treatments. The topics addressed in this article are: (1) unaddressed end points to pursue in future studies, (2) roles for devices to enhance rescue medication clinical development programs, (3) tools to study seizure cluster prediction and prevention, (4) the value of other designs for seizure cluster studies, and (5) unique challenges of future trial paradigms for seizure clusters. By focusing on novel end points and technologies with value to patients, caregivers, and clinicians, data obtained from future studies can benefit the diverse patient population that experiences seizure clusters, providing more effective, appropriate care as well as alleviating demands on health care resources.
临床研究中，用于治疗癫痫群发作的抢救药物有限，这些研究旨在满足监管要求，而这些要求可能并不能完全考虑到经历癫痫群发作的患者群体的多样化需求，也可能无法充分利用抢救药物。本叙述性综述的目的是研究影响癫痫群发作研究质量的因素，以期改善临床实践。我们讨论了五个未满足的需求领域，并就如何加强癫痫群治疗的未来试验提供了建议。本文讨论的主题包括：（1）未来研究中需要关注的未解决终点，（2）设备在增强抢救药物临床开发项目中的作用，（3）研究癫痫群预测和预防的工具，（4）其他设计方案在癫痫群研究中的价值，以及（5）癫痫群未来试验范式的独特挑战。通过关注对患者、护理人员和临床医生有价值的新终点和技术，未来研究获得的数据将使经历癫痫群发作的患者群体受益，提供更有效、更合适的治疗方法，同时减轻对医疗资源的需求。
