拉莫三嗪与卡马西平作为新诊断或复发癫痫患者单药治疗的随机开放多中心对照试验

A randomised open multicentre comparative trial of lamotrigine and carbamazepine as monotherapy in patients with newly diagnosed or recurrent epilepsy.

作者信息

Reunanen M, Dam M, Yuen A W

机构信息

Department of Neurology, University of Oulu, Finland.

出版信息

Epilepsy Res. 1996 Mar;23(2):149-55. doi: 10.1016/0920-1211(95)00085-2.

DOI:10.1016/0920-1211(95)00085-2

Abstract

The efficacy and safety of lamotrigine and carbamazepine as monotherapy in patients with untreated, newly diagnosed or recurrent partial and/or generalised tonic-clonic seizures, were compared in a randomised, open, multicentre study. Patients received 24 weeks' treatment with oral lamotrigine 100 mg (LTG 100, n = 115) or 200 mg (LTG 200, n = 111) or carbamazepine 600 mg (CBZ 600, n = 117). Efficacy measurements were comparable between the three treatment groups, although the higher lamotrigine dose was possibly most effective, with 60.4% completing seizure free compared with 51.3% (LTG 100) and 54.7% (CBZ 600). Both dosage regimens of lamotrigine were well tolerated. More patients on CBZ 600 reported adverse experiences, 66% versus 53% (LTG 100) and 58% (LTG 200), and of these a greater proportion were attributed to CBZ 600 treatment, 53% versus 23% (LTG 100) and 28% (LTG 200). Similarly, a greater proportion of the CBZ 600 group required a change in dose, 47% versus 20% (LTG 100) and 17% (LTG 200) or withdrew completely due to adverse experiences, 10.3% versus 4.3% (LTG 100) and 4.5% (LTG 200). The most common adverse experience leading to withdrawal was rash, with approximately double the proportion of reports occurring in patients on CBZ 600 (5.1%) compared with lamotrigine (1.7% on LTG 100 and 2.7% on LTG 200). Overall lamotrigine appeared equally effective but better tolerated compared with carbamazepine.

摘要

在一项随机、开放、多中心研究中，比较了拉莫三嗪和卡马西平作为单一疗法治疗未经治疗、新诊断或复发的部分性和/或全身性强直阵挛性癫痫患者的疗效和安全性。患者接受为期24周的口服治疗，分别服用拉莫三嗪100mg（LTG 100，n = 115）或200mg（LTG 200，n = 111）或卡马西平600mg（CBZ 600，n = 117）。尽管较高剂量的拉莫三嗪可能最有效，三个治疗组之间的疗效测量结果具有可比性，服用拉莫三嗪200mg的患者无癫痫发作完成治疗的比例为60.4%，而服用拉莫三嗪100mg的患者为51.3%，服用卡马西平600mg的患者为54.7%。拉莫三嗪的两种剂量方案耐受性均良好。服用卡马西平600mg的患者报告的不良事件更多，分别为66%，而服用拉莫三嗪100mg的患者为53%，服用拉莫三嗪200mg的患者为58%，其中较大比例的不良事件归因于卡马西平600mg治疗，分别为53%，而服用拉莫三嗪100mg的患者为23%，服用拉莫三嗪200mg的患者为28%。同样，卡马西平600mg组中需要改变剂量的患者比例更高，分别为47%，而服用拉莫三嗪100mg的患者为20%，服用拉莫三嗪200mg的患者为17%；或因不良事件而完全停药的患者比例分别为10.3%，而服用拉莫三嗪100mg的患者为4.3%，服用拉莫三嗪200mg的患者为4.5%。导致停药的最常见不良事件是皮疹，服用卡马西平600mg的患者报告的皮疹比例（5.1%）约为服用拉莫三嗪患者的两倍（服用拉莫三嗪LTG 100的患者为1.7%，服用拉莫三嗪LTG 200的患者为2.7%）。总体而言，与卡马西平相比，拉莫三嗪似乎同样有效，但耐受性更好。