Department of Neurology, Epilepsy Center, Sana-Krankenhaus Rummelsberg (teaching hospital of the Friedrich-Alexander-Universität Erlangen-Nürnberg), Schwarzenbruck, Germany.
Department of Neurology, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.
Acta Neurol Scand. 2018 Sep;138(3):195-202. doi: 10.1111/ane.12943. Epub 2018 Apr 16.
The purpose of this study was to evaluate the tolerability and efficacy of brivaracetam (BRV) in residential patients at our epilepsy centre.
We assessed retrospectively 33 patients (14 females; mean age 38.2 years, with range 17-63 years) with intellectual disability (ID) and drug-resistant epilepsy using an industry-independent, non-interventional study design based on standardized daily seizure records. Mean seizure frequency was compared between the 3-month baseline period and subsequent 3-month treatment period. Evaluation, including calculation of retention rate, was carried out for the intervals 3-6 and 9-12 months after brivaracetam initiation. Responders were defined as having a 50% reduction in seizure frequency. The Clinical Global Impression scale (CGI) was applied to allow assessment of qualitative changes in seizure severity, and the Aggressive Behaviour Scale (ABS) gave further insights into challenging behaviour.
The responder rate was 19%, and one non-responder attained an improvement in CGI score. The retention rate after 12 months was 37%. Brivaracetam treatment was stopped because of adverse events (n = 3), lack of efficacy (n = 8) or both (n = 6). Thirteen patients experienced behavioural changes, with aggressive behaviour being the commonest effect. We also observed ataxia (n = 2), gastrointestinal disorder (n = 3) and sedation (n = 2). The ABS showed deterioration, or new occurrence, of aggressive behaviour in 13 patients.
Brivaracetam seems to be effective in a small number of patients suffering from difficult-to-treat epilepsy and intellectual disability. Challenging behaviour was documented in a relevant number of patients, with psychiatric illness being a risk factor for this.
本研究旨在评估我们癫痫中心住院患者使用布瓦加坦（BRV）的耐受性和疗效。
我们采用独立于行业的非干预性研究设计，基于标准化的日常癫痫发作记录，回顾性评估了 33 名（14 名女性；平均年龄 38.2 岁，范围 17-63 岁）有智力障碍（ID）和耐药性癫痫的患者。比较了 3 个月基线期和随后 3 个月治疗期的平均癫痫发作频率。在开始使用布瓦加坦后 3-6 个月和 9-12 个月进行评估，包括计算保留率。将发作频率减少 50%的患者定义为有反应者。应用临床总体印象量表（CGI）评估癫痫严重程度的定性变化，并用攻击行为量表（ABS）进一步了解挑战性行为。
反应率为 19%，1 名无反应者CGI 评分改善。12 个月的保留率为 37%。因不良事件（n=3）、疗效不佳（n=8）或两者兼而有之（n=6）停用布瓦加坦。13 名患者出现行为改变，攻击行为是最常见的影响。我们还观察到共济失调（n=2）、胃肠道疾病（n=3）和镇静（n=2）。ABS 显示 13 名患者的攻击行为恶化或新出现。
布瓦加坦似乎对少数患有难治性癫痫和智力障碍的患者有效。有相当数量的患者出现挑战性行为，精神疾病是这种行为的一个危险因素。
