抗癫痫药物三联疗法治疗伴难治性癫痫的脑胶质瘤患者的有效性：一项观察性队列研究。
Effectiveness of Antiseizure Medication Triple Therapy in Patients With Glioma With Refractory Epilepsy: An Observational Cohort Study.
机构信息
From the Leiden University Medical Center (P.B.v.d.M., L.D., M.F., M.J.V., M.J.B.T., J.A.F.K.); Haaglanden Medical Center (P.B.v.d.M., L.D., M.J.V., J.A.F.K.), The Hague; Amsterdam University Medical Centers (M.C.M.K.); and Erasmus Medical Center (M.J.v.d.B.), Rotterdam, the Netherlands.
出版信息
Neurology. 2023 Apr 4;100(14):e1488-e1496. doi: 10.1212/WNL.0000000000206852. Epub 2023 Feb 8.
BACKGROUND AND OBJECTIVES
Approximately 10% of patients with glioma with epilepsy need antiseizure medication (ASM) triple therapy due to refractory epilepsy. The aim of this study was to evaluate whether levetiracetam combined with valproic acid and clobazam (LEV + VPA + CLB), a frequently prescribed triple therapy, has favorable effectiveness compared with other triple therapy combinations in patients with glioma.
METHODS
This was a multicenter retrospective observational cohort study. The primary outcome was the cumulative incidence of time to treatment failure for any reason, from the start of ASM triple therapy treatment. The secondary outcomes included cumulative incidences of the following: (1) time to treatment failure due to uncontrolled seizures; (2) time to treatment failure due to adverse effects; and (3) time to recurrent seizures. Patients were followed up for a maximum duration of 36 months.
RESULTS
Of 1,435 patients in the original cohort, 90 patients received ASM triple therapy after second-line ASM treatment failure due to uncontrolled seizures. LEV + VPA + CLB was prescribed to 48% (43/90) and other ASM triple therapy to 52% (47/90) of patients. The cumulative incidence of treatment failure for any reason of LEV + VPA + CLB did not statistically significantly differ from that of other ASM triple therapy combinations (12 months: 47% [95% CI 31%-62%] vs 42% [95% CI 27%-56%], = 0.892). No statistically significant differences for treatment failure due to uncontrolled seizures (12 months: 12% [95% CI 4%-25%] vs 18% [95% CI 8%-30%], = 0.445), adverse effects (12 months: 22% [95% CI 11%-36%] vs 15% [95% CI 7%-27%], = 0.446), or recurrent seizures (1 month: 65% [95% CI 48%-78%] vs 63% [95% CI 47%-75%], = 0.911) were found.
DISCUSSION
LEV + VPA + CLB might show equivalent effectiveness compared with other ASM triple therapy combinations in patients with glioma.
CLASSIFICATION OF EVIDENCE
This study provides Class III evidence that for patients with glioma with refractory epilepsy on triple therapy ASMs, LEV + VPA + CLB demonstrated similar effectiveness and tolerability compared with other ASM triple therapy combinations.
背景与目的
约 10%的伴癫痫的胶质瘤患者由于难治性癫痫需要抗癫痫药物（ASM）三联治疗。本研究旨在评估抗癫痫药物三联治疗中，左乙拉西坦联合丙戊酸和氯巴占（LEV+VPA+CLB）是否比其他三联治疗组合更有效。
方法
这是一项多中心回顾性观察队列研究。主要结局是从 ASM 三联治疗开始的任何原因导致治疗失败的时间的累积发生率。次要结局包括以下各项的累积发生率：（1）因无法控制的癫痫发作而导致治疗失败的时间；（2）因不良反应而导致治疗失败的时间；（3）癫痫复发的时间。患者的随访时间最长为 36 个月。
结果
在原始队列的 1435 名患者中，有 90 名患者在二线 ASM 治疗因无法控制的癫痫发作失败后接受了 ASM 三联治疗。48%（43/90）的患者接受了 LEV+VPA+CLB 治疗，52%（47/90）的患者接受了其他 ASM 三联治疗。LEV+VPA+CLB 治疗失败的任何原因的累积发生率与其他 ASM 三联治疗组合无统计学显著差异（12 个月：47%[95%CI 31%-62%] vs 42%[95%CI 27%-56%]，=0.892）。在因无法控制的癫痫发作而导致治疗失败的时间方面也无统计学显著差异（12 个月：12%[95%CI 4%-25%] vs 18%[95%CI 8%-30%]，=0.445）、不良反应（12 个月：22%[95%CI 11%-36%] vs 15%[95%CI 7%-27%]，=0.446）或癫痫复发（1 个月：65%[95%CI 48%-78%] vs 63%[95%CI 47%-75%]，=0.911）方面也未发现统计学显著差异。
讨论
LEV+VPA+CLB 可能与其他 ASM 三联治疗组合在伴难治性癫痫的胶质瘤患者中具有等效疗效。
证据分类
本研究提供了 III 级证据，表明对于接受抗癫痫药物三联治疗的难治性癫痫伴胶质瘤患者，LEV+VPA+CLB 与其他 ASM 三联治疗组合相比，具有相似的疗效和耐受性。
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