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临床试验中癫痫发作严重程度的定量评估:癫痫发作成分评估方法综述

Quantitative assessment of seizure severity for clinical trials: a review of approaches to seizure components.

作者信息

Cramer J A, French J

机构信息

Departments of Neurology and Psychiatry, Yale University School of Medicine, New Haven, Connecticut, USA.

出版信息

Epilepsia. 2001 Jan;42(1):119-29. doi: 10.1046/j.1528-1157.2001.19400.x.

Abstract

Quantitative assessment of seizure severity has been approached using a variety of systems. This review describes currently available methods and possible new approaches to seizure assessment for clinical trials. A review of the literature on methods of seizure assessments resulted in tabulation of the seizure rating scales known as VA, Chalfont-National Hospital, Liverpool, Hague, and the Occupational Hazard Scale. Seizures have been evaluated by simply counting all events, counting events by type, by clinician ratings, patient ratings, and combinations. Each of the scales has advantages and disadvantages. Most scales share core components: seizure frequency, seizure type, seizure duration, postictal events, postictal duration, automatisms, seizure clusters, known patterns, warnings, tongue biting, incontinence, injuries, and functional impairment. This review revealed a partial consensus about aspects of seizures that are important markers for severity. However, usefulness of the existing scales is limited by lack of data on responsiveness. New approaches are needed to assess changes in seizure severity as a result of an intervention in a clinical trial.

摘要

已经使用多种系统对癫痫发作严重程度进行定量评估。本综述描述了目前可用于临床试验的癫痫发作评估方法以及可能的新方法。对有关癫痫发作评估方法的文献进行综述后,列出了称为VA、查尔方特-国家医院、利物浦、海牙和职业危害量表的癫痫发作评分量表。癫痫发作的评估方法包括简单地统计所有发作事件、按类型统计发作事件、由临床医生评分、患者评分以及多种方式的组合。每个量表都有其优缺点。大多数量表都有核心组成部分:发作频率、发作类型、发作持续时间、发作后事件、发作后持续时间、自动症、发作簇、已知模式、先兆、咬舌、大小便失禁、损伤和功能障碍。本综述揭示了对于作为严重程度重要标志的癫痫发作各方面存在部分共识。然而,现有量表的实用性因缺乏反应性数据而受到限制。需要新的方法来评估在临床试验中由于干预导致的癫痫发作严重程度的变化。

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