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在临床实践中,从卡马西平或奥卡西平转换为乙琥胺的安全性、耐受性和有效性。

Safety, tolerability and effectiveness of transition to eslicarbazepine acetate from carbamazepine or oxcarbazepine in clinical practice.

机构信息

Epilepsy Monitoring Unit, Department of Neurology, Hospital Del Mar-Hospital del Mar Medical Research Institute (IMIM), Barcelona, Spain.

Department of Neurology, Tampere University and Tampere University Hospital, Tampere, Finland.

出版信息

Seizure. 2020 Feb;75:121-128. doi: 10.1016/j.seizure.2019.12.022. Epub 2019 Dec 23.

DOI:10.1016/j.seizure.2019.12.022
PMID:31981862
Abstract

PURPOSE

To assess the efficacy, safety and tolerability of eslicarbazepine acetate (ESL) in patients transitioning from carbamazepine or oxcarbazepine to ESL in clinical practice, by analysing data from the Euro-Esli study.

METHODS

Euro-Esli was a pooled analysis of 14 European clinical practice studies. Effectiveness assessments included responder rate (≥50 % seizure frequency reduction) and seizure freedom rate (seizure freedom at least since prior visit), assessed after 3, 6 and 12 months of ESL treatment, and at the last visit. Safety and tolerability were assessed throughout follow-up by evaluating adverse events (AEs) and ESL discontinuation due to AEs, respectively. Data were analysed for cohorts of patients who transitioned from carbamazepine and oxcarbazepine to ESL either due to lack of efficacy or poor tolerability.

RESULTS

Euro-Esli included 2058 patients, of whom 233 (11.3 %) transitioned from carbamazepine to ESL and 134 (6.5 %) transitioned from oxcarbazepine to ESL. After 12 months of ESL treatment, responder and seizure freedom rates for patients transitioning from carbamazepine due to lack of efficacy (n = 163) were 70.0 % and 30.9 %, respectively. Corresponding values for patients transitioning from oxcarbazepine due to lack of efficacy (n = 90) were 57.1 % and 25.0 %, respectively. Among patients who transitioned from carbamazepine and oxcarbazepine to ESL due to poor tolerability (n = 64 and n = 61, respectively), 26.6 % and 39.5 % experienced AEs, and 8.3 % and 6.8 % discontinued ESL due to AEs, respectively.

CONCLUSION

ESL was efficacious and generally well tolerated in patients transitioning from carbamazepine or oxcarbazepine in clinical practice due to inadequate seizure control or intolerable AEs with these agents.

摘要

目的

通过分析 Euro-Esli 研究的数据,评估醋酸艾司利卡西平(ESL)在临床实践中从卡马西平或奥卡西平转换为 ESL 的患者的疗效、安全性和耐受性。

方法

Euro-Esli 是 14 项欧洲临床实践研究的汇总分析。有效性评估包括应答率(≥50%的癫痫发作频率降低)和无癫痫发作率(至少自上次就诊以来无癫痫发作),在 ESL 治疗 3、6 和 12 个月后以及最后一次就诊时进行评估。通过评估不良事件(AE)和因 AE 而停用 ESL,分别在整个随访期间评估安全性和耐受性。对于因疗效不佳或不耐受而从卡马西平或奥卡西平转换为 ESL 的患者队列,分析数据。

结果

Euro-Esli 纳入了 2058 名患者,其中 233 名(11.3%)因疗效不佳从卡马西平转换为 ESL,134 名(6.5%)因奥卡西平转换为 ESL。在 ESL 治疗 12 个月后,因疗效不佳从卡马西平转换为 ESL 的患者(n=163)的应答率和无癫痫发作率分别为 70.0%和 30.9%。因疗效不佳从奥卡西平转换为 ESL 的患者(n=90)的相应值分别为 57.1%和 25.0%。因不耐受而从卡马西平或奥卡西平转换为 ESL 的患者(n=64 和 n=61)中,分别有 26.6%和 39.5%出现 AE,分别有 8.3%和 6.8%因 AE 而停用 ESL。

结论

在临床实践中,ESL 对于因控制不佳或对这些药物不耐受而从卡马西平或奥卡西平转换而来的患者,具有疗效且通常耐受性良好。

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