A biomarker is a characteristic that can be objectively measured as an indicator of normal biologic processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions. Biomarker modalities include molecular, histologic, radiographic, or physiologic characteristics. To improve the understanding and use of biomarker terminology in biomedical research, clinical practice, and medical product development, the Food and Drug Administration (FDA)-National Institutes of Health (NIH) Joint Leadership Council developed the BEST Resource (Biomarkers, EndpointS, and other Tools). The seven BEST biomarker categories include the following: (a) susceptibility/risk biomarkers, (b) diagnostic biomarkers, (c) monitoring biomarkers, (d) prognostic biomarkers, (e) predictive biomarkers, (f) pharmacodynamic/response biomarkers, and (g) safety biomarkers. We hypothesize some potential overlap between the reported biomarkers of traumatic brain injury (TBI), epilepsy, and posttraumatic epilepsy (PTE). Here, we tested this hypothesis by reviewing studies focusing on biomarker discovery for posttraumatic epileptogenesis and epilepsy. The biomarker modalities reviewed here include plasma/serum and cerebrospinal fluid molecular biomarkers, imaging biomarkers, and electrophysiologic biomarkers. Most of the reported biomarkers have an area under the receiver operating characteristic curve greater than 0.800, suggesting both high sensitivity and high specificity. Our results revealed little overlap in the biomarker candidates between TBI, epilepsy, and PTE. In addition to using single parameters as biomarkers, machine learning approaches have highlighted the potential for utilizing patterns of markers as biomarkers. Although published data suggest the possibility of identifying biomarkers for PTE, we are still in the early phase of the development curve. Many of the seven biomarker categories lack PTE-related biomarkers. Thus, further exploration using proper, statistically powered, and standardized study designs with validation cohorts, and by developing and applying novel analytical methods, is needed for PTE biomarker discovery.

中文翻译：

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创伤后癫痫的生物标志物

生物标志物是一种特征，可以作为正常生物过程、致病过程或对暴露或干预（包括治疗干预）反应的指标进行客观测量。生物标志物形式包括分子、组织学、放射学或生理学特征。为了提高生物医学研究、临床实践和医疗产品开发中生物标志物术语的理解和使用，美国食品和药物管理局 (FDA)-美国国立卫生研究院 (NIH) 联合领导委员会开发了 BEST 资源（生物标志物、端点和其他工具）。七个最佳生物标志物类别包括：(a) 易感性/风险生物标志物，(b) 诊断生物标志物，(c) 监测生物标志物，(d) 预后生物标志物，(e) 预测生物标志物，(f) 药效学/反应生物标志物，和 (g) 安全性生物标志物。我们假设所报告的外伤性脑损伤 (TBI)、癫痫和创伤后癫痫 (PTE) 的生物标志物之间存在一些潜在的重叠。在这里，我们通过回顾专注于创伤后癫痫发生和癫痫的生物标志物发现的研究来检验这一假设。此处审查的生物标志物方式包括血浆/血清和脑脊液分子生物标志物、成像生物标志物和电生理生物标志物。大多数报道的生物标志物的接受者操作特征曲线下面积大于 0.800，表明具有高灵敏度和高特异性。我们的结果显示 TBI、癫痫和 PTE 之间的候选生物标志物几乎没有重叠。除了使用单一参数作为生物标志物外，机器学习方法突出了利用标记模式作为生物标志物的潜力。尽管已发表的数据表明有可能识别 PTE 的生物标志物，但我们仍处于发展曲线的早期阶段。七个生物标志物类别中的许多都缺乏 PTE 相关的生物标志物。因此，PTE 生物标志物的发现需要使用适当的、统计上有效的和标准化的研究设计与验证队列进行进一步探索，并通过开发和应用新的分析方法。