Topiramate, carbamazepine and valproate monotherapy: double-blind comparison in newly diagnosed epilepsy
Topiramate, carbamazepine and valproate monotherapy: double-blind comparison in newly diagnosed epilepsy
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DOI：
10.1034/j.1600-0404.2003.00093.x
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发表时间：
2003-03-01
影响因子：
3.5
通讯作者：
Wang, S
中科院分区：
文献类型：
--
作者：
Privitera, MD;Brodie, MJ;Wang, S
目的：比较托吡酯(TPM)与研究人员选择的卡马西平(CBZ)或丙戊酸盐(VPA)对新诊断的癫痫患者的初始治疗。材料和方法：在过去3个月内确诊的癫痫患者中，研究者根据患者的临床表现选择CBZ(600 mg/天)或VPA(1250 mg/天)作为首选治疗方法。根据研究人员的治疗选择，患者(n=613)被分配到CBZ或VPA治疗分支。在每个分支中，患者随机接受传统抗癫痫药物(CBZ或VPA)、TPM 100 mg/天或TPM 200 mg/天的双盲治疗。患者继续双盲治疗，直到退出研究或直到最后一名患者随机后6个月。结果-固定剂量的TPM与CBZ或VPA在疗效指标：退出时间、首次发作时间以及患者在最后6个月内无癫痫发作的比例方面没有统计学上的差异。TPM 100毫克/天与因不良事件而中断治疗的次数最少有关。结论-在新诊断的癫痫患者中，最初的目标剂量TPM 100 mg/d至少与治疗剂量的CBZ和VPA一样有效。
Objectives - To compare topiramate (TPM) with investigator's choice of carbamazepine (CBZ) or valproate (VPA) for initial treatment in patients with newly diagnosed epilepsy. Material and methods - In patients with epilepsy diagnosed within previous 3 months, investigators selected CBZ (600 mg/day) or VPA (1250 mg/day) as preferred therapy based on the patient's clinical presentation. Based on investigators' treatment choice, patients (n = 613) were assigned to the CBZ or VPA treatment branch. Within each branch, patients were randomized to double-blind treatment with the traditional antiepileptic drugs (CBZ or VPA), TPM 100 mg/day, or TPM 200 mg/day. Patients continued double-blind treatment until exiting the study or until 6 months after last patient randomized. Results - No statistically significant differences between fixed doses of TPM and CBZ or VPA were observed in efficacy measures: time to exit, time to first seizure, and the proportion of patients seizure-free during the last 6 months of treatment. TPM 100 mg/day was associated with the fewest discontinuations due to adverse events. Conclusion - In patients with newly diagnosed epilepsy, an initial target dose of TPM 100 mg/day is at least as effective as therapeutic doses of CBZ and VPA.