Not all that glitters is gold: A guide to critical appraisal of animal drug trials in epilepsy.
Not all that glitters is gold: A guide to critical appraisal of animal drug trials in epilepsy.
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DOI：
10.1002/epi4.12021
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发表时间：
2016-12-01
期刊：
影响因子：
3
通讯作者：
Mowrey, Wenzhu B
中科院分区：
文献类型：
--
作者：
Galanopoulou, Aristea S;Mowrey, Wenzhu B
临床前研究已经产生了许多具有抗癫痫特性的药物，这些药物目前是临床护理中的护理标准。三分之一的癫痫患者仍然继续癫痫发作，尽管正在进行的发现。需要解决的公认的临床护理差距是确定抗癫痫和疾病修饰治疗，治疗难治性癫痫发作或癫痫发作和癫痫治疗有限或不满意，如早期癫痫性脑病。在这篇特邀评论中，我们提供了一个国际努力的历史总结，以重新评估临床前癫痫治疗发现研究中采用的策略。我们讨论了可能影响临床前研究的质量、解释和验证的问题，以及将其转化为成功治疗癫痫患者的问题。这些包括动物模型的选择和研究设计，影响严谨性的研究实践，例如适当使用统计数据和报告研究方法和结果，它们在模型，实验室和临床前-临床研究中的验证，协调研究方法和结果评估的必要性，以及改善临床适当情况的重要性。癫痫研究界正在逐步采用合作研究，包括联盟或多中心研究，以满足这些需求。改善能够支持这些努力的基础设施将有助于未来的成功。
Preclinical studies have produced numerous drugs with antiseizure properties which currently are the standard of care in clinical care. A third of the human population with epilepsy still continues having seizures despite the ongoing discoveries. The recognized clinical gaps of care that need to be addressed are the identification of antiepileptogenic and disease modifying treatments, treatments for refractory seizures or for seizures and epilepsies with limited or unsatisfactory treatments, such as early life epileptic encephalopathies. In this invited review, we provide a historical summary of the international efforts to re-evaluate the strategies adopted in preclinical epilepsy therapy discovery studies. We discuss issues that may impact the quality, interpretation and validation of preclinical studies and their translation to successful therapies for humans affected with epilepsy. These include the selection of animal models and the study design, research practices that affect rigor, such as appropriate use of statistics and reporting of study methods and results, their validation across models, labs and preclinical-clinical studies, the need to harmonize research methods and outcome assessment, and the importance to improve translation to clinically appropriate situations. The epilepsy research community is incrementally adopting collaborative research, including consortia or multicenter studies to meet these needs. Improving the infrastructure that can support these efforts will be instrumental in the future success.