Department of Neurology, Mayo Clinic, Rochester, Minnesota 55905, USA.
J Neurosurg. 2010 Dec;113(6):1176-81. doi: 10.3171/2010.5.JNS091367. Epub 2010 Jun 18.
Second-generation antiepileptic drugs (AEDs) are increasingly used in the care of patients with glioma. There is little data on how this practice compares with the use of traditional AEDs in this population. This noninferiority analysis compares seizure outcomes and side effects in patients with glioma treated with phenytoin and levetiracetam monotherapy.
The authors retrospectively reviewed the records of 500 consecutive patients with glioma who were treated in clinical trials from 2001 to 2008 at 3 Mayo Clinic campuses. To be eligible for the study, these patients had to have had at least 1 clinical seizure and to have undergone follow-up for at least 6 months. Seizure outcomes, defined by the occurrence of a second seizure, time to second seizure, and seizure frequency, along with AED side effects, were compared between cohorts treated with phenytoin or levetiracetam
Seventy-six patients were identified, 25 treated with phenytoin and 51 with levetiracetam. Sixty-four percent of the patients had a Grade 4 astrocytoma. There was no difference in seizure outcome between the phenytoin and levetiracetam groups when comparing time to second seizure (p=0.584), second seizure rates (p=0.561), and average seizures per month (p=0.776). When adjusting for age, sex, type of seizure, type of glioma, and dosage using univariate and multivariate models, there were no differences between the treatment groups and none of these covariates were statistically significant for explaining the second seizure rates between treatment groups (all p values>0.05). The incidence of side effects in the levetiracetam group was 6% versus 20% in the phenytoin group (p=0.106). Additionally, 36% of the patients in the phenytoin group had dose adjustments unrelated to breakthrough seizures compared with only 10% in the levetiracetam group (p=0.010)
In this study, patients with glioma treated with levetiracetam and phenytoin had similar seizure control. Patients treated with levetiracetam experienced fewer side effects and required fewer nonseizure-related dose adjustments than patients treated with phenytoin. Levetiracetam is a safe, effective, and preferred alternative for seizure management in patients with glioma.
第二代抗癫痫药物(AEDs)在胶质瘤患者的治疗中越来越多地被应用。关于这种治疗方式与传统 AED 在该人群中的应用比较的数据较少。本非劣效性分析比较了接受苯妥英和左乙拉西坦单药治疗的胶质瘤患者的癫痫发作结局和副作用。
作者回顾性分析了 2001 年至 2008 年在 3 家梅奥诊所院区进行的临床试验中连续 500 例胶质瘤患者的记录。为了符合研究条件,这些患者必须至少有 1 次临床发作,并至少随访 6 个月。比较了接受苯妥英或左乙拉西坦治疗的队列之间的癫痫发作结局(定义为第二次发作、第二次发作时间和发作频率)和 AED 副作用。
确定了 76 例患者,其中 25 例接受苯妥英治疗,51 例接受左乙拉西坦治疗。64%的患者患有 4 级星形细胞瘤。比较两组间第二次发作时间(p=0.584)、第二次发作率(p=0.561)和平均每月发作次数(p=0.776),苯妥英组和左乙拉西坦组之间的癫痫发作结局无差异。在单变量和多变量模型中,当调整年龄、性别、发作类型、胶质瘤类型和剂量时,治疗组之间无差异,且这些协变量均无统计学意义,无法解释治疗组之间的第二次发作率(所有 p 值>0.05)。左乙拉西坦组的副作用发生率为 6%,而苯妥英组为 20%(p=0.106)。此外,与左乙拉西坦组的 10%相比,苯妥英组中 36%的患者因非突破性发作而调整剂量(p=0.010)。
在这项研究中,接受左乙拉西坦和苯妥英治疗的胶质瘤患者的癫痫控制情况相似。与接受苯妥英治疗的患者相比,接受左乙拉西坦治疗的患者副作用更少,且不需要与非发作相关的剂量调整。左乙拉西坦是管理胶质瘤患者癫痫发作的安全、有效和首选替代药物。