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布瓦西坦在临床实践中的疗效和耐受性:一项基于英国的回顾性多中心服务评估。

Brivaracetam efficacy and tolerability in clinical practice: A UK-based retrospective multicenter service evaluation.

机构信息

Academic Neurology Unit, University of Sheffield, UK.

The Walton Centre, NHS Foundation Trust, Liverpool, UK.

出版信息

Epilepsy Behav. 2020 May;106:106967. doi: 10.1016/j.yebeh.2020.106967. Epub 2020 Mar 14.

DOI:10.1016/j.yebeh.2020.106967
PMID:32179501
Abstract

PURPOSE

This multicenter service evaluation explores the efficacy and tolerability of brivaracetam (BRV) in an unselected, consecutive population in 'real-life' clinical settings.

METHOD

We retrospectively collected data from patient records at 11 UK hospitals and epilepsy centers. Consecutive patients prescribed BRV with at least 3 months of follow-up (FU) were included. Apart from reporting effectiveness and tolerability of BRV across the whole cohort, we compared treatment outcomes depending on previous levetiracetam use (LEV+ versus LEV-), comorbid learning disability (LD+ versus LD-), and epilepsy syndrome (focal versus generalized epilepsy).

RESULTS

Two hundred and ninety patients (46% male, median age: 38 years, range: 15 to 77) with ≥3 months of FU were included. The median duration of BRV exposure was 12 months (range: 1 day to 72 months). Overall BRV retention was 71.1%. While 56.1% of patients improved in terms of seizure frequency category (daily, weekly, monthly, yearly seizures), 23.1% did not improve on this measure and 20.8% deteriorated. In terms of seizure frequency, 21% of patients experienced a ≥50% reduction, with 7.0% of all patients becoming seizure-free. Treatment-emergent adverse events (AEs) were reported by 107 (36.9%) patients, but there were no serious AEs. The commonest AEs were sedation/fatigue (18.3%), mood changes (9.0%), and irritability/aggression (4.8%). There were no significant differences in drug retention, seizure frequency outcomes, or AEs between the LEV+ and LEV- subgroups, or between patients with generalized or focal epilepsies. Although 15.5% of patients in the LD+ group achieved a ≥50% reduction, this rate was lower than in the LD- group.

CONCLUSIONS

This 'real-life' evaluation suggests that reductions in seizure frequency can be achieved with BRV in patients with highly refractory epilepsy. Brivaracetam may be a useful treatment option in patients who have previously failed to respond to or tolerate LEV, those with LD, or (off-label) those with generalized epilepsies.

摘要

目的

本多中心服务评估在“真实生活”临床环境中,对未经选择的连续人群中布瓦西坦(BRV)的疗效和耐受性进行探索。

方法

我们从 11 家英国医院和癫痫中心的患者病历中回顾性收集数据。纳入至少有 3 个月随访(FU)的连续使用 BRV 治疗的患者。除了报告整个队列的 BRV 有效性和耐受性外,我们还根据先前使用左乙拉西坦(LEV+与 LEV-)、合并学习障碍(LD+与 LD-)和癫痫综合征(局灶性与全面性癫痫)比较治疗结局。

结果

共纳入 290 例(46%为男性,中位年龄:38 岁,范围:15-77 岁)患者,有≥3 个月 FU。BRV 暴露的中位时间为 12 个月(范围:1 天至 72 个月)。总体 BRV 保留率为 71.1%。56.1%的患者在发作频率类别(每日、每周、每月、每年发作)方面有所改善,23.1%的患者在这一指标上没有改善,20.8%的患者恶化。就发作频率而言,21%的患者发作减少≥50%,7.0%的患者完全无发作。107 例(36.9%)患者报告出现治疗相关不良事件(AE),但无严重 AE。最常见的 AE 是镇静/疲劳(18.3%)、情绪改变(9.0%)和易激惹/攻击性(4.8%)。LEV+与 LEV-亚组之间、全面性或局灶性癫痫患者之间,药物保留率、发作频率结局或 AE 无显著差异。虽然 LD+组中 15.5%的患者发作减少≥50%,但这一比例低于 LD-组。

结论

这项“真实生活”评估表明,在高度耐药性癫痫患者中,BRV 可降低发作频率。BRV 可能是那些先前对 LEV 反应不佳或不耐受、有学习障碍、或(超适应证)患有全面性癫痫患者的有用治疗选择。

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