Laboratory for Neurotherapeutics, Department of Neurology, Comprehensive Epilepsy Center, Biomedical Research Institute, Seoul National University Hospital, Seoul, South Korea.
Rare Disease Center, Department of Genomic Medicine, Seoul National University Hospital, Seoul, South Korea.
Epilepsia Open. 2021 Jun;6(2):394-401. doi: 10.1002/epi4.12495. Epub 2021 May 7.
Lamotrigine is one of the most widely used antiepileptic drugs, but it has a critical issue of a skin rash if the starting dose is too high or the escalation rate is too rapid. We investigated the efficacy and safety of a novel and rapid titration protocol for lamotrigine that takes only 11 days to reach a daily dose of 200 mg.
We prospectively enrolled 33 adult patients (age 18-85) who were diagnosed with epilepsy and started lamotrigine administration for the first time at a single tertiary hospital. Our new protocol starts with a subthreshold dose of the drug and then administers a stepwise-incremental dose until reaching the full therapeutic dose within 11 days.
Of 29 patients analyzed, only two (6.9%) experienced idiosyncratic skin rash before the first follow-up visit at 2 weeks (±3 days). In addition, a therapeutic concentration was reached in more than 75% of studied patients after 2 weeks of lamotrigine administration.
These findings demonstrate the value of the novel tolerance induction protocol for lamotrigine, which could widen the available application of lamotrigine in various situations. However, this study is a preliminary study limited by a small number of patients and its nonrandomized and open-label design, so the current protocol needs more rigorous clinical evaluations before the application to the real clinical setting.
拉莫三嗪是最广泛使用的抗癫痫药物之一，但如果起始剂量过高或递增速度过快，会出现皮疹等严重问题。我们研究了一种新的、快速滴定拉莫三嗪的方案，该方案只需 11 天即可达到 200mg 的日剂量，评估其疗效和安全性。
我们前瞻性地招募了 33 名成年患者（年龄 18-85 岁），这些患者在一家三级医院首次被诊断为癫痫，并开始服用拉莫三嗪。我们的新方案从亚治疗剂量开始，然后逐步递增剂量，在 11 天内达到全治疗剂量。
在 29 名可分析的患者中，只有 2 名（6.9%）在第 2 周（±3 天）的首次随访前出现特发性皮疹。此外，在服用拉莫三嗪 2 周后，超过 75%的研究患者达到了治疗浓度。
这些发现表明拉莫三嗪的新耐受诱导方案具有价值，这可能会扩大拉莫三嗪在各种情况下的应用。然而，由于该研究患者数量较少、设计非随机且为开放性，这限制了其结果，因此目前的方案在实际临床应用前还需要更严格的临床评估。
