目的:癫痫是最常见的神经系统疾病之一。布立西坦(BRV)是一种值得注意的抗癫痫药物(ASM),其特征在于与脑内突触囊泡蛋白2A(SV2A)的显着和选择性相互作用。先前的调查,包括监管试验,上市后评估,和比较荟萃分析,一直强调BRV与其他抗癫痫药物在疗效和耐受性方面的等效性。本研究旨在评估有效性,安全,以及BRV在巴基斯坦人群中治疗癫痫患者的可接受性。
方法:这项前瞻性观察研究,2022年2月至12月在巴基斯坦进行,采用非概率连续抽样技术。这项研究包括368名诊断为癫痫的成年患者,重点关注18岁及以上的局灶性癫痫患者。人口统计数据,临床病史,癫痫发作类型,并记录癫痫情况。患者接受BRV(Brivera;由HelixPharmaPvtLtd.制造,信德省,巴基斯坦)在医生指导下进行单一疗法治疗,并随访三个月。这项研究评估了癫痫发作频率的变化,副作用,和基线时的耐药性,第14天,第90天安全方面进行了监测,包括记录与BRV治疗相关的任何不良反应。
结果:本研究共纳入368例癫痫患者,其中男性287人(61.3%),女性181人(38.7%)。平均年龄为32.91±17.11岁。基线访视时的平均癫痫发作次数为5.74±6.21,14天时为2.89±3.84,90天时为1.73±5.01(p<0.001)。总的来说,在第90天,178例(56.3%)患者的癫痫发作减少超过50%,在第14天,95例(26.8%)患者的癫痫发作减少少于50%,两者之间存在高度显著的相关性(p<0.001).在316名患者中,所有接受BRV治疗的患者中只有41例(4.4%)出现不良事件;在这41例患者中,17人(41.7%)报告头晕,14人(34.2%)报告行为问题。
结论:接受BRV的癫痫患者在随访结束时表现出超过50%的癫痫发作显著减少。此外,BRV在癫痫患者中表现出较少的不良反应。
OBJECTIVE: Epilepsy stands out as one of the most prevalent neurological conditions. Brivaracetam (BRV) is a noteworthy antiseizure medication (ASM) distinguished by its pronounced and selective interaction with the synaptic vesicle protein 2A (SV2A) within the brain. Prior investigations, including regulatory trials, post-marketing assessments, and comparative meta-analyses, have consistently underscored BRV\'s equivalency in efficacy and superior tolerability when pitted against other antiseizure drugs. This
study aimed to evaluate the effectiveness, safety, and acceptability of BRV in treating epileptic patients in the Pakistani population.
METHODS: This prospective observational
study, conducted in Pakistan from February to December 2022, employed a non-probability consecutive sampling technique. This
study included 368 adult patients diagnosed with epilepsy, with a focus on those aged 18 and above experiencing focal seizures. Demographic data, clinical history, seizure types, and epilepsy profiles were recorded. Patients were administered BRV (Brivera; manufactured by Helix Pharma Pvt Ltd., Sindh, Pakistan) monotherapy therapy under physician guidance and followed up for three months. The
study assessed changes in seizure frequency, side effects, and drug resistance at baseline, 14th day, and 90th day. Safety aspects were monitored, including documenting any adverse effects associated with BRV therapy.
RESULTS: A total of 368 epileptic patients were included in this
study, of which 287 (61.3%) were males and 181 (38.7%) were females. The mean age was 32.91±17.11 years. The mean number of seizures at the baseline visit was 5.74±6.21, at 14 days was 2.89±3.84 and at 90 days was 1.73±5.01 (p<0.001). Overall, a more than 50% reduction in seizure episodes was achieved in 178 (56.3%) patients at day 90, and less than 50% reduction in seizure episodes was achieved by 95 (26.8%) patients on Day 14, with a highly significant association between them (p<0.001). Among 316 patients, only 41 (4.4%) of all BRV-treated patients experienced adverse events; Of these 41 patients, 17 (41.7%) reported dizziness and 14(34.2%) reported behavioral issues.
CONCLUSIONS: Epileptic patients receiving BRV demonstrated a substantial reduction of greater than 50% seizure episodes at the end of follow-up visits. Moreover, BRV exhibited fewer adverse effects in individuals with epilepsy.