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TRENdS 研究:复发性电临床无抽搐发作的治疗。

Treatment of Recurrent Electrographic Nonconvulsive Seizures (TRENdS) study.

机构信息

Department of Medicine (Neurology), Duke University Medical Center and Neurodiagnostic Center, Veterans Affairs Medical Center, Durham, NC 27710, U.S.A.

出版信息

Epilepsia. 2013 Sep;54 Suppl 6:84-8. doi: 10.1111/epi.12287.

Abstract

Nonconvulsive seizures (NCS) and nonconvulsive status epilepticus (NCSE) are electrographic seizures (ESz) that are not associated with overt clinical seizure activity. NCS are distinct ESz, whereas NCSE has ongoing, continuous electrographic seizure activity. Both are common in critically ill patients admitted to hospital intensive care units (ICUs), and studies have shown that about 20% of ICU patients undergoing continuous electroencephalography (cEEG) monitoring will have NCS/NCSE. Although the treatment for convulsive SE is well established, there is no clear consensus for the treatment of NCS/NCSE. Antiepileptic drugs (AEDs), such as phenytoin (PHT) and fosphenytoin (fPHT), used in convulsive SE are also used to treat NCS/NCSE despite lack of data for their appropriateness for these conditions. Recent studies have shown that very aggressive treatment of NCSss/NCSE can lead to worse outcomes because the AEDs used can have significant adverse effects. Recently, several intravenous (IV) AEDs have become available for substitution therapy when their oral use is not possible. There are retrospective case reports and case series that suggest that these AEDs may be beneficial for treatment of NCS/NCSE. The Treatment of Recurrent Electrographic Nonconvulsive Seizures (TRENdS) Study will compare the efficacy and tolerability of fPHT and lacosamide in patients having NCS as noted by cEEG monitoring. The study is currently open to recruitment and has 13 sites in the United States. A total of 200 subjects will be randomized, 100 to each treatment arm.

摘要

非惊厥性发作(NCS)和非惊厥性癫痫持续状态(NCSE)是与明显临床发作活动无关的电发作(ESz)。NCS 是独特的 ESz,而 NCSE 则具有持续不断的电发作活动。两者在入住医院重症监护病房(ICU)的危重病患者中都很常见,研究表明,大约 20%接受连续脑电图(cEEG)监测的 ICU 患者会出现 NCS/NCSE。尽管治疗惊厥性 SE 的方法已经确立,但对于 NCS/NCSE 的治疗尚无明确共识。抗癫痫药(AED),如苯妥英(PHT)和磷苯妥英(fPHT),在惊厥性 SE 中使用,也用于治疗 NCS/NCSE,尽管缺乏这些情况下使用它们的适当性的数据。最近的研究表明,对 NCS/NCSE 的非常积极的治疗可能会导致更糟糕的结果,因为使用的 AED 可能会产生重大的不良反应。最近,几种静脉(IV)AED 已可用于替代治疗,当无法口服使用时。有回顾性病例报告和病例系列表明,这些 AED 可能对治疗 NCS/NCSE 有益。复发性脑电图非惊厥性发作(TRENdS)研究将比较 cEEG 监测到 NCS 时磷苯妥英和拉考酰胺在患者中的疗效和耐受性。该研究目前正在招募参与者,在美国有 13 个研究地点。共有 200 名受试者将被随机分配,每个治疗组 100 名。

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