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拉考沙胺治疗胶质瘤伴发癫痫发作控制不佳的患者:一项观察性研究的结果。

Lacosamide in patients with gliomas and uncontrolled seizures: results from an observational study.

机构信息

Department of Neuro-Oncology, University and City of Health and Science Hospital, via Cherasco 15, 10126, Turin, Italy.

Unit of Cancer Epidemiology (CPO Piemonte) and University of Turin, Turin, Italy.

出版信息

J Neurooncol. 2018 Jan;136(1):105-114. doi: 10.1007/s11060-017-2628-0. Epub 2017 Oct 13.

DOI:10.1007/s11060-017-2628-0
PMID:29030718
Abstract

To report the efficacy and tolerability of lacosamide as an add-on treatment in patients with gliomas and uncontrolled seizures despite conventional antiepileptic drugs (AEDs). We conducted an observational study on 71 patients to describe patterns of response to lacosamide and the association between clinico-pathological factors and seizure control. We observed at 3, 6 and 9 months a seizure reduction ≥ 50% in 74.6, 76 and 86.2% of patients and a seizure freedom in 42.2, 43 and 50%, respectively. The median number of seizures in the 3 months before treatment was 13, and decreased to 3 between baseline and 6 months, and to 0.5 between 6 and 9 months. The best seizure response was observed at 3 months (62%). Sixty per cent of patients displayed the maximum seizure control with doses of lacosamide of 100-250 mg/day, while 21% needed doses up to 400 mg/day. Seizure reduction ≥ 50% and seizure freedom were higher in patients who received lacosamide as first add-on compared to those who received a later adjunctive therapy. A reduction ≥ 50% of seizures was observed in a proportion of patients with progressive disease on MRI. Age > 45 years (OR 0.11, 95% CI 0.02-0.63, p = 0.013) was a significant predictor of seizure freedom at 9 months on multivariate analysis. The study suggests that lacosamide, when added to any baseline AEDs, is effective in obtaining a high seizure reduction and seizure freedom regardless of the tumor activity and response to antineoplastic therapies.

摘要

报告拉科酰胺作为附加治疗在患有胶质瘤和尽管使用了传统抗癫痫药物(AEDs)但仍无法控制的癫痫发作患者中的疗效和耐受性。我们对 71 例患者进行了一项观察性研究,以描述拉科酰胺的反应模式以及临床病理因素与癫痫控制之间的关系。我们观察到,在 3、6 和 9 个月时,分别有 74.6%、76%和 86.2%的患者癫痫发作减少≥50%,分别有 42.2%、43%和 50%的患者癫痫发作消失。治疗前 3 个月的平均癫痫发作次数为 13 次,从基线到 6 个月时减少到 3 次,从 6 个月到 9 个月时减少到 0.5 次。最佳的癫痫发作缓解出现在 3 个月时(62%)。60%的患者在使用拉科酰胺 100-250mg/天的剂量时达到最大的癫痫控制效果,而 21%的患者需要使用高达 400mg/天的剂量。拉科酰胺作为一线附加治疗的患者比那些接受二线附加治疗的患者癫痫发作减少≥50%和癫痫发作消失的比例更高。在 MRI 上显示疾病进展的患者中,有一部分患者观察到癫痫发作减少≥50%。多变量分析显示,年龄>45 岁(OR 0.11,95%CI 0.02-0.63,p=0.013)是 9 个月时癫痫发作消失的显著预测因素。该研究表明,拉科酰胺作为附加治疗,无论肿瘤活性和抗肿瘤治疗的反应如何,在添加到任何基线 AEDs 时都能有效获得较高的癫痫发作减少和癫痫发作消失。

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本文引用的文献

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Neuro Oncol. 2017 Jan;19(1):12-21. doi: 10.1093/neuonc/now190. Epub 2016 Sep 20.
2
Intravenous lacosamide in clinical practice-Results from an independent registry.临床实践中静脉注射拉科酰胺——一项独立注册研究的结果
Seizure. 2016 Jul;39:5-9. doi: 10.1016/j.seizure.2016.01.008. Epub 2016 Jan 12.
3
A long-term noninterventional safety study of adjunctive lacosamide therapy in patients with epilepsy and uncontrolled partial-onset seizures.
左乙拉西坦和拉科酰胺在替莫唑胺联合放疗辅助治疗期间对异柠檬酸脱氢酶野生型胶质母细胞瘤患者生存及癫痫控制的影响
Brain Spine. 2023 Dec 14;4:102732. doi: 10.1016/j.bas.2023.102732. eCollection 2024.
4
Surgical management of Glioma Grade 4: technical update from the neuro-oncology section of the Italian Society of Neurosurgery (SINch®): a systematic review.SINch®:意大利神经外科学会神经肿瘤学分会关于 4 级神经胶质瘤的手术治疗:技术更新:系统评价。
J Neurooncol. 2023 Apr;162(2):267-293. doi: 10.1007/s11060-023-04274-x. Epub 2023 Mar 24.
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Epilepsy treatment in neuro-oncology: A rationale for drug choice in common clinical scenarios.神经肿瘤学中的癫痫治疗:常见临床场景下药物选择的基本原理。
Front Pharmacol. 2022 Oct 6;13:991244. doi: 10.3389/fphar.2022.991244. eCollection 2022.
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拉科酰胺辅助治疗癫痫及部分性发作控制不佳患者的长期非干预性安全性研究。
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Neuro Oncol. 2016 Jun;18(6):779-89. doi: 10.1093/neuonc/nov269. Epub 2015 Nov 2.
7
A noninterventional study evaluating the effectiveness and safety of lacosamide added to monotherapy in patients with epilepsy with partial-onset seizures in daily clinical practice: The VITOBA study.一项在日常临床实践中评估拉考酰胺添加到单药治疗对部分性发作癫痫患者有效性和安全性的非干预性研究:VITOBA研究。
Epilepsia. 2015 Dec;56(12):1921-30. doi: 10.1111/epi.13224. Epub 2015 Nov 3.
8
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