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癫痫手术的多中心研究:手术的招募与选择

The multicenter study of epilepsy surgery: recruitment and selection for surgery.

作者信息

Berg Anne T, Vickrey Barbara G, Langfitt John T, Sperling Michael R, Walczak Thaddeus S, Shinnar Shlomo, Bazil Carl W, Pacia Steven V, Spencer Susan S

机构信息

BIOS/NIU, DeKalb, Illinois 60115, USA.

出版信息

Epilepsia. 2003 Nov;44(11):1425-33. doi: 10.1046/j.1528-1157.2003.24203.x.

Abstract

PURPOSE

Multiple studies have examined predictors of seizure outcomes after epilepsy surgery. Most are single-center series with limited sample size. Little information is available about the selection process for surgery and, in particular, the proportion of patients who ultimately have surgery and the characteristics that identify those who do versus those who do not. Such information is necessary for providing the epidemiologic and clinical context in which epilepsy surgery is currently performed in the United States and in other developed countries.

METHODS

An observational cohort of 565 surgical candidates was prospectively recruited from June 1996 through January 2001 at six Northeastern and one Midwestern surgical centers. Standardized eligibility criteria and protocol for presurgical evaluations were used at all seven sites.

RESULTS

Three hundred ninety-six (70%) study subjects had resective surgery. Clinical factors such as a well-localized magnetic resonance imaging (MRI) abnormality and consistently localized EEG findings were most strongly associated with having surgery. Of those who underwent intracranial monitoring (189, 34%), 85% went on to have surgery. Race/ethnicity and marital status were marginally associated with having surgery. Age, education, and employment status were not. Demographic factors had little influence over the surgical decision. More than half of the patients had intractable epilepsy for >/=10 years and five or more drugs had failed by the time they initiated their surgical evaluation. During the recruitment period, eight new antiepileptic drugs were approved by the Food and Drug Administration for use in the United States and came into increasing use in this study's surgical candidates. Despite the increased availability of new therapeutic options, the proportion that had surgery each year did not fluctuate significantly from year to year. This suggests that, in this group of patients, the new drugs did not provide a substantial therapeutic benefit.

CONCLUSIONS

Up to 30% of patients who undergo presurgical evaluations for resective epilepsy surgery ultimately do not have this form of surgery. This is a group whose needs are not currently met by available therapies and procedures. Lack of clear localizing evidence appears to be the main reason for not having surgery. To the extent that these data can address the question, they suggest that repeated attempts to control intractable epilepsy with new drugs will not result in sustained seizure control, and eligible patients will proceed to surgery eventually. This is consistent with recent arguments to consider surgery earlier rather than later in the course of epilepsy. Postsurgical follow-up of this group will permit a detailed analysis of presurgical factors that predict the best and worst seizure outcomes.

摘要

目的

多项研究探讨了癫痫手术后发作结果的预测因素。大多数研究是单中心系列研究,样本量有限。关于手术的选择过程,尤其是最终接受手术的患者比例以及区分接受手术和未接受手术患者的特征,相关信息较少。此类信息对于了解美国及其他发达国家目前进行癫痫手术的流行病学和临床背景是必要的。

方法

1996年6月至2001年1月期间,在东北部的六个和中西部的一个外科中心前瞻性招募了565名手术候选者组成观察队列。所有七个地点均采用标准化的入选标准和术前评估方案。

结果

396名(70%)研究对象接受了切除性手术。临床因素,如定位良好的磁共振成像(MRI)异常和脑电图结果持续定位,与接受手术的关联最为密切。在接受颅内监测的患者中(189名,34%),85%最终接受了手术。种族/民族和婚姻状况与接受手术有微弱关联。年龄、教育程度和就业状况则无关联。人口统计学因素对手术决策影响不大。超过一半的患者患有难治性癫痫超过10年,在开始手术评估时,五种或更多药物治疗均失败。在招募期间,有八种新型抗癫痫药物获得美国食品药品监督管理局批准在美国使用,并在本研究的手术候选者中越来越多地被使用。尽管有更多新的治疗选择,但每年接受手术的比例并没有显著波动。这表明,在这组患者中,新药并未带来实质性的治疗益处。

结论

接受切除性癫痫手术术前评估的患者中,高达30%最终未接受这种手术形式。这是一组现有治疗方法和程序目前无法满足其需求的患者。缺乏明确的定位证据似乎是未进行手术的主要原因。就这些数据能够回答的问题而言,它们表明,用新药反复尝试控制难治性癫痫不会导致癫痫发作持续得到控制,符合条件的患者最终将接受手术。这与近期主张在癫痫病程中尽早而非推迟考虑手术的观点一致。对这组患者进行术后随访将有助于详细分析预测最佳和最差癫痫发作结果的术前因素。

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