Donaldson J A, Glauser T A, Olberding L S
Department of Neurology, Children's Hospital Medical Center, Cincinnati, Ohio 45229-3039, USA.
Epilepsia. 1997 Jan;38(1):68-73. doi: 10.1111/j.1528-1157.1997.tb01079.x.
We assessed efficacy and safety of adjunctive lamotrigine (LTG) therapy in patients with the Lennox-Gastaut syndrome (LGS).
The study was a single-center, retrospective chart review of open-label adjunctive LTG therapy in patients with LGS. Initial LTG dose and titration was dependent on concomitant antiepileptic drugs (AEDs). Efficacy was based on the change in seizure frequency between the initiation of LTG therapy and December 1, 1995 (or LTG discontinuation). Seizure diaries were used to count patient seizures. A secondary evaluation of efficacy was a parental or guardian assessment of the patient's global status. The evaluation of safety involved chart review for treatment-emergent adverse events (AE).
Data from 16 LGS patients were analyzed. Fifty-three percent (8 of 15) had a > 50% reduction in seizure frequency with LTG adjunctive therapy. Tonic, atonic, generalized tonic-clonic (GTCS), and atypical absence seizure frequency but not myoclonic seizure frequency decreased significantly during LTG therapy. Fifty-three percent of the patient's parents (8 of 15) reported that their child's quality of life (QOL) was much or very much improved during the study. The major treatment-emergent AE were infection (50%, 8 of 16) and sleep disturbance (19%, 3 of 16). A rash was noted in 13% (2 of 16) of the patients and resulted in LTG discontinuation in 1. No clinically significant changes were noted in neurologic examination or laboratory tests during the study.
Our results indicate that LTG adjunctive therapy is effective and well tolerated in patients with LGS.
我们评估了拉莫三嗪（LTG）辅助治疗 Lennox-Gastaut 综合征（LGS）患者的疗效和安全性。
本研究是一项对 LGS 患者开放标签 LTG 辅助治疗的单中心回顾性病历审查。初始 LTG 剂量和滴定取决于同时使用的抗癫痫药物（AEDs）。疗效基于 LTG 治疗开始至 1995 年 12 月 1 日（或 LTG 停药）期间癫痫发作频率的变化。使用癫痫发作日记来统计患者的癫痫发作次数。疗效的次要评估是家长或监护人对患者整体状况的评估。安全性评估包括对治疗中出现的不良事件（AE）进行病历审查。
分析了 16 例 LGS 患者的数据。53%（15 例中的 8 例）患者在接受 LTG 辅助治疗后癫痫发作频率降低了 50%以上。在 LTG 治疗期间，强直、失张力、全身强直阵挛（GTCS）和非典型失神发作频率显著下降，但肌阵挛发作频率未下降。53%的患者家长（15 例中的 8 例）报告称，在研究期间他们孩子的生活质量（QOL）有很大或非常大的改善。主要的治疗中出现的 AE 是感染（50%，16 例中的 8 例）和睡眠障碍（19%，16 例中的 3 例）。13%（16 例中的 2 例）的患者出现皮疹，其中 1 例因皮疹导致停用 LTG。研究期间，神经系统检查或实验室检查未发现临床显著变化。
我们的结果表明，LTG 辅助治疗对 LGS 患者有效且耐受性良好。
