现实环境中早期加用拉科酰胺：REALLY研究结果
Early add-on lacosamide in a real-life setting: results of the REALLY study.
作者信息
Villanueva Vicente, Garcés Mercedes, López-Gomáriz Elena, Serratosa José María, González-Giráldez Beatriz, Parra Jaime, Rodríguez-Uranga Juan, Toledo Manuel, López González Francisco Javier, Bermejo Pedro, Giner Pau, Castillo Ascensión, Molins Albert, Campos Dulce, Mauri José Ángel, Muñoz Rosario, Bonet Macarena, Serrano-Castro Pedro, del Villar Ana, Saiz-Díaz Rosa Ana
机构信息
Hospital Universitario y Politécnico La Fe, Bulevard Sur, s/n, Carretera de Malilla, 46026, Valencia, Spain,
出版信息
Clin Drug Investig. 2015 Feb;35(2):121-31. doi: 10.1007/s40261-014-0255-5.
BACKGROUND AND OBJECTIVES
Many patients with epilepsy are treated with antiepileptic drug (AED) polytherapy. Several factors influence the choice of early add-on therapy, and deciding on the most appropriate drug can be difficult. This study aimed to assess the efficacy and tolerability of lacosamide as early add-on therapy in patients with partial-onset seizures.
METHODS
REALLY (REtrospective study of lAcosamide as earLy add-on aLong one Year) was a multicenter, retrospective, 1-year, real-life study. Patients included were aged older than 16 years, had partial-onset seizures, and were treated with lacosamide as add-on therapy after one or two prior AEDs. Data were collected retrospectively from clinical records. The primary study objective was to assess the efficacy of lacosamide over 12 months (seizure-free and responder rates), and the secondary objective was to assess the tolerability of lacosamide at 3, 6, and 12 months [adverse events (AEs) and discontinuation].
RESULTS
One hundred and ninety-nine patients were enrolled in the study; 89 patients (44.7 %) had tried one AED and 110 patients (55.3 %) had tried two AEDs before lacosamide. At 12 months, the proportion of patients who were seizure free was 44.9 %, and 76 % of patients were responders. The seizure-free rate at 12 months for patients who had previously received one or two AEDs was 58 and 34.3 %, and the responder rate at 12 months was 83.0 and 70.4 %, respectively. The AE rate was 21.5 % at 3 months, 27.1 % at 6 months, and 31.2 % at 12 months, with 7.0 % of patients discontinuing treatment because of an AE. The most common AE reported was dizziness (11.6 %). Cryptogenic epilepsy, a higher number of prior AEDs, and the use of a sodium channel blocker at onset were associated with a worse outcome. The number of concomitant AEDs decreased over 1 year (Z = 5.89; p < 0.001). Twenty-two patients were converted to lacosamide monotherapy with at least one evaluation ≥6 months from the beginning of monotherapy conversion.
CONCLUSIONS
Lacosamide was effective and well tolerated as early add-on treatment in patients who had received one or two previous AEDs.
背景与目的
许多癫痫患者接受抗癫痫药物（AED）联合治疗。有几个因素会影响早期附加治疗的选择，而决定最合适的药物可能会很困难。本研究旨在评估拉科酰胺作为部分性发作患者早期附加治疗的疗效和耐受性。
方法
REALLY（拉科酰胺作为早期附加治疗长达一年的回顾性研究）是一项多中心、回顾性、为期1年的真实世界研究。纳入的患者年龄大于16岁，有部分性发作，并且在使用一或两种先前的AED后接受拉科酰胺作为附加治疗。数据从临床记录中回顾性收集。主要研究目的是评估拉科酰胺在12个月内的疗效（无癫痫发作率和有效率），次要目的是评估拉科酰胺在3、6和12个月时的耐受性[不良事件（AE）和停药情况]。
结果
199名患者纳入研究；89名患者（44.7%）在使用拉科酰胺前尝试过一种AED，110名患者（55.3%）尝试过两种AED。在12个月时，无癫痫发作的患者比例为44.9%，76%的患者有效。先前接受过一种或两种AED的患者在12个月时的无癫痫发作率分别为58%和34.3%，12个月时的有效率分别为83.0%和70.4%。3个月时AE发生率为21.5%，6个月时为27.1%，12个月时为31.2%，7.0%的患者因AE停药。报告的最常见AE是头晕（11.6%）。隐源性癫痫、先前使用AED的数量较多以及起病时使用钠通道阻滞剂与较差的预后相关。1年内联合使用的AED数量减少（Z = 5.89；p < 0.001）。22名患者转换为拉科酰胺单药治疗，从单药治疗转换开始至少有一次评估≥6个月。
结论
拉科酰胺作为早期附加治疗，对先前接受过一或两种AED的患者有效且耐受性良好。
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