Department of Neurosurgery, Medical Faculty, Heinrich-Heine-University, Düsseldorf, Germany.
Medical Affairs Europe, Neuromodulation, LivaNova Deutschland GmbH (a LivaNova PLC owned subsidiary), Munich, Germany.
Acta Neurol Scand. 2021 May;143(5):497-508. doi: 10.1111/ane.13375. Epub 2020 Dec 1.
Lennox-Gastaut syndrome (LGS) is among the most severe epileptic and developmental encephalopathies. A meta-analysis was performed to evaluate the effectiveness of adjunctive vagus nerve stimulation (VNS Therapy) in patients with LGS.
MATERIALS & METHODS: PubMed database was queried (January 1997 to September 2018) to identify publications reporting on the efficacy of VNS Therapy in patients with LGS, with or without safety findings. Primary endpoint of the meta-analysis was the proportion of responders (≥50% reduction in seizure frequency). Random-effects analysis was used to calculate weighted mean estimates and confidence intervals. Heterogeneity was evaluated by statistical tests including I .
Of 2752 citations reviewed, 17 articles (480 patients) were eligible including 10 retrospective studies and seven prospective studies. A random-effects model produced a pooled proportion of 54% (95% confidence intervals [CI]: 45%, 64%) of patients with LGS who responded to adjunctive VNS Therapy (p for heterogeneity <0.001, I =72.9%). Per an exploratory analysis, the calculated incidence of serious adverse events associated with VNS Therapy was 9% (95% CI: 5%, 14%); the rate was higher than in long-term efficacy studies of heterogeneous cohorts with drug-resistant epilepsy and likely attributed to variable definitions of serious adverse events across studies.
The meta-analysis of 480 patients with LGS suggests that 54% of patients responded to adjunctive VNS Therapy and that the treatment option was safe and well-tolerated. The response in patients with LGS was comparable to heterogeneous drug-resistant epilepsy populations. A clinical and surgical overview has been included to facilitate the use of VNS in LGS.
Lennox-Gastaut 综合征(LGS)是最严重的癫痫和发育性脑病之一。进行了一项荟萃分析,以评估迷走神经刺激(VNS 疗法)辅助治疗 LGS 患者的有效性。
检索 PubMed 数据库(1997 年 1 月至 2018 年 9 月),以确定报告 VNS 疗法治疗 LGS 患者有效性(有无安全性发现)的出版物。荟萃分析的主要终点是应答者的比例(发作频率减少≥50%)。使用随机效应分析计算加权均数估计值和置信区间。通过包括 I²在内的统计检验评估异质性。
在审查的 2752 篇引文中有 17 篇文章(480 例患者)符合纳入标准,包括 10 项回顾性研究和 7 项前瞻性研究。随机效应模型得出的 LGS 患者对辅助性 VNS 治疗有反应的比例为 54%(95%置信区间[CI]:45%,64%)(异质性检验 p<0.001,I²=72.9%)。根据一项探索性分析,与 VNS 治疗相关的严重不良事件发生率为 9%(95%CI:5%,14%);这一比率高于药物难治性癫痫的异质性队列的长期疗效研究,可能归因于研究间严重不良事件的定义不同。
对 480 例 LGS 患者的荟萃分析表明,54%的患者对辅助性 VNS 治疗有反应,并且该治疗选择是安全且耐受良好的。LGS 患者的反应与异质性药物难治性癫痫人群相当。已纳入临床和手术概述,以促进 VNS 在 LGS 中的应用。