Pediatric Neurology Division, Department of Pediatrics, All India Institute of Medical Sciences, Rishikesh, India.
Department of Pediatrics, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
Acta Neurol Scand. 2021 Oct;144(4):366-374. doi: 10.1111/ane.13469. Epub 2021 May 17.
To compare the evidence on efficacy, safety, tolerability, and impact on short term/long functional outcome of lacosamide (LCM) and phenytoin (PHT) in patients with status epilepticus.
MATERIALS & METHODS: We conducted a systematic literature search of relevant electronic databases using a suitable search strategy to identify studies directly comparing PHT and LCM, irrespective of dose and duration in patients with convulsive and/or nonconvulsive status epilepticus (SE). We used a standardized assessment form to extract information on the study design, data sources, methodologic framework, efficacy, and adverse events attributed to PHT and LCM from included studies and compared the efficacy and safety outcomes, using a fixed/random effect model.
Five studies were found to be eligible for inclusion out of 192 search items, enrolling a total of 115 and 166 participants (predominantly with SE) in LCM and PHT arm, respectively. Baseline characteristics were comparable between both arms. The proportion with seizure control was comparable between both arms (57.3% in LCM vs. 45.7% in PHT arm, p = 0.28) and even in the subgroup analysis separately for convulsive and non-convulsive SE. Proportion with treatment-emergent adverse events (TEAE) were comparable in both (17.6% vs. 12.2%, p = 0.20), but serious adverse events (SAE) were higher in PHT arm (5.1% vs. 0.8%, p = 0.049). The proportion with all-cause mortality and survival with moderate-severe disability were comparable between both arms (p = 0.23 and 0.37, respectively).
LCM has comparable efficacy with fewer SAEs as compared to PHT for achieving seizure control in patients with SE.
比较左乙拉西坦(LCM)和苯妥英(PHT)治疗癫痫持续状态(SE)患者的疗效、安全性、耐受性及对短期/长期功能结局的影响。
我们系统地检索了相关电子数据库,使用合适的搜索策略,以确定直接比较 PHT 和 LCM 的研究,无论剂量和疗程如何,纳入患有惊厥性和/或非惊厥性 SE 的患者。我们使用标准化评估表从纳入的研究中提取关于研究设计、数据来源、方法学框架、疗效和归因于 PHT 和 LCM 的不良事件的信息,并使用固定/随机效应模型比较疗效和安全性结局。
从 192 项搜索结果中发现 5 项研究符合纳入标准,共纳入 115 例和 166 例(主要为 SE)接受 LCM 和 PHT 治疗的患者。两组的基线特征具有可比性。两组的癫痫控制比例相似(LCM 组为 57.3%,PHT 组为 45.7%,p=0.28),甚至在分别针对惊厥性和非惊厥性 SE 的亚组分析中也是如此。两组的治疗中出现的不良事件(TEAE)发生率相似(LCM 组为 17.6%,PHT 组为 12.2%,p=0.20),但 PHT 组的严重不良事件(SAE)发生率更高(5.1%比 0.8%,p=0.049)。两组的全因死亡率和中度至重度残疾生存率相似(p=0.23 和 0.37)。
与 PHT 相比,LCM 控制 SE 发作的疗效相当,但 SAE 发生率较低。