Pediatric Neurology Division, Department of Pediatrics, All India Institute of Medical Sciences, Rishikesh, Uttarakhand 249203, India.
Pediatric Neurology Division, Department of Pediatrics, All India Institute of Medical Sciences, Rishikesh, Uttarakhand 249203, India.
Seizure. 2021 Oct;91:296-307. doi: 10.1016/j.seizure.2021.07.004. Epub 2021 Jul 9.
Rufinamide is an antiseizure medication that acts through sodium channels and is found to be efficacious in patients with Lennox Gastaut syndrome (LGS). However, no systematic review has been conducted in LGS patients to provide an estimate of the efficacy and safety of rufinamide.
Different electronic databases were searched for articles describing the use of rufinamide in patients with LGS. For determining primary efficacy outcomes as compared to placebo, we included only studies comparing the efficacy of rufinamide with placebo in LGS patients. We performed an additional analysis to include other uncontrolled studies with a minimum sample size of 20 to provide a more comprehensive estimate of efficacy.
A total of ten studies included 557 patients. Out of them, five studies were placebo-controlled, enrolling a total of 265 patients in the rufinamide group and 203 patients in the placebo group. The average percentage reduction in total seizure frequency per 28 days during the double-blind phase was 29.3% in the rufinamide group compared with 8.3% in the placebo group (difference between the two groups was 20.9%, 95%CI-14.4%-27.3%, p <0.00001). Even for individual seizure types like tonic-clonic seizures, atypical absence seizures, atonic seizures, focal seizures, and myoclonic seizures, rufinamide was more efficacious than placebo(p<0.00001). The number of patients with at least one treatment-emergent adverse effects was significantly higher in rufinamide treated patients (60.2%vs50.7%, p=0.02, RR-1.24(1.03,1.51).
Rufinamide is efficacious as adjunctive therapy in patients with LGS in terms of reduction in total seizure frequency and has mild adverse reaction.
鲁非尼胺是一种抗癫痫药物，通过钠离子通道起作用，已被证明对 Lennox-Gastaut 综合征（LGS）患者有效。然而，目前尚未对 LGS 患者进行系统评价，以提供鲁非尼胺疗效和安全性的估计。
搜索了描述鲁非尼胺在 LGS 患者中应用的不同电子数据库。为了确定与安慰剂相比的主要疗效结局，我们仅纳入了比较 LGS 患者中鲁非尼胺与安慰剂疗效的研究。我们进行了额外的分析，纳入了其他最小样本量为 20 例的非对照研究，以提供更全面的疗效估计。
共有 10 项研究纳入了 557 名患者。其中 5 项为安慰剂对照研究，共纳入鲁非尼胺组 265 例和安慰剂组 203 例患者。在双盲期，每 28 天总癫痫发作频率的平均降低率在鲁非尼胺组为 29.3%，安慰剂组为 8.3%（两组之间的差异为 20.9%，95%CI-14.4%-27.3%，p<0.00001）。即使对于强直-阵挛性发作、非典型失神发作、失张力发作、局灶性发作和肌阵挛性发作等个别癫痫发作类型，鲁非尼胺也比安慰剂更有效（p<0.00001）。鲁非尼胺治疗组至少有一次治疗中出现不良事件的患者比例显著高于安慰剂组（60.2%比 50.7%，p=0.02，RR-1.24（1.03，1.51）。
鲁非尼胺作为 LGS 患者的辅助治疗是有效的，可降低总癫痫发作频率，且不良反应轻微。
