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脑肿瘤切除术中围手术期癫痫预防的系统评价:多中心随机临床试验的案例。

A systematic review of perioperative seizure prophylaxis during brain tumor resection: the case for a multicenter randomized clinical trial.

机构信息

Department of Neurosurgery, Virginia Commonwealth University Health System, Medical College of Virginia; and.

Department of Biostatistics, Virginia Commonwealth University, Richmond, Virginia.

出版信息

Neurosurg Focus. 2017 Nov;43(5):E18. doi: 10.3171/2017.8.FOCUS17442.

DOI:10.3171/2017.8.FOCUS17442
PMID:29088958
Abstract

OBJECTIVE The majority of neurosurgeons administer antiepileptic drugs (AEDs) prophylactically for supratentorial tumor resection without clear evidence to support this practice. The putative benefit of perioperative seizure prophylaxis must be weighed against the risks of adverse effects and drug interactions in patients without a history of seizures. Consequently, the authors conducted a systematic review of prospective randomized controlled trials (RCTs) that have evaluated the efficacy of perioperative seizure prophylaxis among patients without a history of seizures. METHODS Five databases (PubMed/MEDLINE, Cochrane Central Register of Controlled Trials, CINAHL/Academic Search Complete, Web of Science, and ScienceDirect) were searched for RCTs published before May 2017 and investigating perioperative seizure prophylaxis in brain tumor resection. Of the 496 unique research articles identified, 4 were selected for inclusion in this review. RESULTS This systematic review revealed a weighted average seizure rate of 10.65% for the control groups. There was no significant difference in seizure rates among the groups that received seizure prophylaxis and those that did not. Further, this expected incidence of new-onset postoperative seizures would require a total of 1258 patients to enroll in a RCT, as determined by a Farrington-Manning noninferiority test performed at the 0.05 level using a noninferiority difference of 5%. CONCLUSIONS According to a systematic review of major RCTs, the administration of prophylactic AEDs after brain tumor resection shows no significant reduction in the incidence of seizures compared with that in controls. A large multicenter randomized clinical trial would be required to assess whether perioperative seizure prophylaxis provides benefit for patients undergoing brain tumor resection.

摘要

目的

大多数神经外科医生在进行幕上肿瘤切除时预防性地使用抗癫痫药物(AEDs),但没有明确的证据支持这种做法。必须权衡围手术期癫痫预防的潜在益处与无癫痫病史患者的不良反应和药物相互作用的风险。因此,作者对评估无癫痫病史患者围手术期癫痫预防效果的前瞻性随机对照试验(RCT)进行了系统回顾。

方法

检索了 5 个数据库(PubMed/MEDLINE、Cochrane 中央对照试验注册库、CINAHL/学术搜索完整、Web of Science 和 ScienceDirect),以查找 2017 年 5 月之前发表的评估脑肿瘤切除术中围手术期癫痫预防的 RCT。在 496 篇独特的研究文章中,有 4 篇被选入本综述。

结果

本系统综述显示对照组的癫痫发作率加权平均值为 10.65%。接受癫痫预防和未接受癫痫预防的组之间的癫痫发作率没有显著差异。此外,通过在 0.05 水平上使用非劣效性差异为 5%的 Farrington-Manning 非劣效性检验,需要总共 1258 例患者入组 RCT,才能确定这一预期的新发术后癫痫发生率。

结论

根据对主要 RCT 的系统回顾,与对照组相比,脑肿瘤切除术后预防性使用 AEDs 并不能显著降低癫痫发作的发生率。需要进行大型多中心随机临床试验来评估围手术期癫痫预防是否对接受脑肿瘤切除术的患者有益。

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