Department of Pediatrics, Peking University First Hospital, Beijing, China.
Department of Neurology, Peking University First Hospital, Beijing, China.
J Neurol. 2023 Oct;270(10):4713-4728. doi: 10.1007/s00415-023-11834-8. Epub 2023 Jun 28.
To compare the efficacy and safety of antiseizure medications (ASMs), both as monotherapies and adjunctive therapies, for idiopathic generalized epilepsies (IGEs) and related entities.
Two reviewers independently searched PubMed, Embase, and the Cochrane Library for relevant randomized controlled trials from December 2022 to February 2023. Studies on the efficacy and safety of ASM monotherapies or adjunctive therapies for IGEs and related entities-including juvenile myoclonic epilepsy, childhood absence epilepsy (CAE), juvenile absence epilepsy, or generalized tonic-clonic seizures alone (GTCA)-were included. Efficacy outcomes were the proportions of patients remaining seizure free for 1, 3, 6, and 12 months; safety outcomes were the proportions of any treatment-emergent adverse event (TEAE) and TEAEs leading to discontinuation. Network meta-analyses were performed in a random-effects model to obtain odds ratios and 95% confidence intervals. Rankings of ASMs were based on the surface under the cumulative ranking curve (SUCRA). This study is registered with PROSPERO (No. CRD42022372358).
Twenty-eight randomized controlled trials containing 4282 patients were included. As monotherapies, all ASMs were more effective than placebo, and valproate and ethosuximide were significantly better than lamotrigine. According to the SUCRA for efficacy, ethosuximide ranked first for CAE, whereas valproate ranked first for other types of IGEs. As adjunctive therapies, topiramate ranked best for GTCA as well as overall for IGEs, while levetiracetam ranked best for myoclonic seizures. For safety, perampanel ranked best (measured by any TEAE).
All of the studied ASMs were more effective than placebo. Valproate monotherapy ranked best overall for IGEs, whereas ethosuximide ranked best for CAE. Adjunctive topiramate and levetiracetam were most effective for GTCA and myoclonic seizures, respectively. Furthermore, perampanel had the best tolerability.
比较抗癫痫药物(ASM)作为单药和辅助治疗在特发性全面性癫痫(IGE)及相关疾病中的疗效和安全性。
两名评审员独立检索了 PubMed、Embase 和 Cochrane 图书馆,以获取 2022 年 12 月至 2023 年 2 月期间关于 IGE 及相关疾病(包括青少年肌阵挛癫痫、儿童失神癫痫、青少年失神癫痫或单纯全面强直阵挛发作)中 ASM 单药或辅助治疗的疗效和安全性的随机对照试验。疗效结局为 1、3、6 和 12 个月无癫痫发作的患者比例;安全性结局为任何治疗相关不良事件(TEAE)和导致停药的 TEAE 比例。采用随机效应模型进行网络荟萃分析,以获得比值比和 95%置信区间。ASM 的排名基于累积排序曲线下面积(SUCRA)。本研究已在 PROSPERO(编号 CRD42022372358)上注册。
纳入了 28 项包含 4282 名患者的随机对照试验。作为单药治疗,所有 ASM 均优于安慰剂,而丙戊酸钠和乙琥胺明显优于拉莫三嗪。根据疗效的 SUCRA,乙琥胺在 CAE 中排名第一,而丙戊酸钠在其他 IGE 类型中排名第一。作为辅助治疗,托吡酯在 GTCA 及总体 IGE 中排名最佳,而左乙拉西坦在肌阵挛发作中排名最佳。在安全性方面,佩南普罗(perampanel)排名最佳(通过任何 TEAE 衡量)。
与安慰剂相比,所有研究中的 ASM 均更有效。丙戊酸钠单药治疗在 IGE 中总体排名最佳,而乙琥胺在 CAE 中排名最佳。托吡酯和左乙拉西坦分别作为辅助治疗对 GTCA 和肌阵挛发作最有效。此外,佩南普罗的耐受性最好。