Nieto-Barrera M, Brozmanova M, Capovilla G, Christe W, Pedersen B, Kane K, O'Neill F
Hospital Virgen del Rocio, Seville, Spain.
Epilepsy Res. 2001 Aug;46(2):145-55. doi: 10.1016/s0920-1211(01)00271-6.
Monotherapy with lamotrigine or carbamazepine was evaluated in a multicentre open trial of patients aged 2 years and above with newly diagnosed partial epilepsy. A total of 417 patients were randomised to treatment with lamotrigine, while 201 patients received carbamazepine. Following a dose escalation period of 6 weeks, maintenance therapy (Weeks 7-24) was adjusted according to response. Efficacy was similar with both treatments (65% with lamotrigine, 73% with carbamazepine, P=0.085). Efficacy was assessed by the proportion of patients seizure free during the last 16 weeks of treatment; all subjects who remained in the study for at least 18 weeks after the week 4 visit were included in the analysis. More patients receiving lamotrigine completed the study (81%), compared with those receiving carbamazepine (77%). This difference was primarily due to discontinuation as a result of adverse events, reported by 34 (8%) of those treated with lamotrigine but 26 (13%) of those treated with carbamazepine. The proportion of patients who experienced adverse events in the lamotrigine group was lower (218 patients, 52%) compared with the carbamazepine group (120 patients, 60%). The proportion of patients with adverse events considered to be drug related was lower in the lamotrigine group (132 patients, 32%) compared with the carbamazepine group (83 patients, 41%). Somnolence was the only adverse event reported at an incidence of greater than 5% and where there was a difference of 5% or more between treatment groups (4% lamotrigine, 11% carbamazepine patients). The small subsets of elderly patients (aged 65 years or over) and paediatric patients (aged 2-12 years) also showed better tolerability to lamotrigine than to carbamazepine. In conclusion, monotherapy with lamotrigine is as effective as carbamazepine in patients with newly diagnosed partial epilepsy. Patients were able to tolerate lamotrigine better than carbamazepine, so more patients receiving lamotrigine were able to remain on therapy.
在一项针对2岁及以上新诊断为部分性癫痫患者的多中心开放性试验中，对拉莫三嗪或卡马西平单药治疗进行了评估。共有417例患者被随机分配接受拉莫三嗪治疗，201例患者接受卡马西平治疗。在6周的剂量递增期后，根据反应调整维持治疗（第7 - 24周）。两种治疗的疗效相似（拉莫三嗪组为65%，卡马西平组为73%，P = 0.085）。疗效通过治疗最后16周无癫痫发作患者的比例进行评估；所有在第4周就诊后至少在研究中持续18周的受试者都纳入分析。与接受卡马西平治疗的患者（77%）相比，接受拉莫三嗪治疗的患者完成研究的比例更高（81%）。这种差异主要是由于不良事件导致的停药，接受拉莫三嗪治疗的患者中有34例（8%）报告了不良事件，而接受卡马西平治疗的患者中有26例（13%）。拉莫三嗪组经历不良事件的患者比例低于卡马西平组（218例患者，52%对比120例患者，60%）。拉莫三嗪组被认为与药物相关的不良事件患者比例低于卡马西平组（132例患者，32%对比83例患者，41%）。嗜睡是唯一报告发生率大于5%且治疗组之间差异达5%或更多的不良事件（拉莫三嗪组4%，卡马西平组11%的患者）。老年患者（65岁及以上）和儿科患者（2 - 12岁）的小亚组对拉莫三嗪的耐受性也优于卡马西平。总之，拉莫三嗪单药治疗在新诊断的部分性癫痫患者中与卡马西平疗效相当。患者对拉莫三嗪的耐受性优于卡马西平，因此接受拉莫三嗪治疗的更多患者能够继续治疗。
