Oxcarbazepine in migraine headache - A double-blind, randomized, placebo-controlled study
Oxcarbazepine in migraine headache - A double-blind, randomized, placebo-controlled study
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DOI：
10.1212/01.wnl.0000297551.27191.70
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发表时间：
2008-02-12
期刊：
影响因子：
9.9
通讯作者：
D'Souza, J.
中科院分区：
文献类型：
--
作者：
Silberstein, S.;Saper, J.;D'Souza, J.
目的：评价奥卡西平（1200mg /天）与安慰剂预防治疗偏头痛患者的疗效、安全性和耐受性。方法：该多中心、双盲、随机、安慰剂对照、平行组试验包括4周的单盲基线期和15周的双盲期，其中包括6周的滴定期、8周的维持期和1周的降滴定期，之后患者可进入13周的开放标签延长期。在6周的滴定期内，奥卡西平起始剂量为150mg/天，每5天增加150mg/天，直至最大耐受剂量为1200mg /天。主要结果测量是在双盲期最后28天期间偏头痛发作次数的基线变化。结果：85例患者随机接受奥卡西平治疗，85例接受安慰剂治疗。奥卡西平组（- 1.30）和安慰剂组在双盲期最后28天偏头痛发作次数的平均变化（-1.74;p = 0.2274）之间没有差异。68例奥卡西平组患者（80%）和55例安慰剂组患者（65%）报告了不良事件。大多数不良事件的严重程度为轻度或中度。奥卡西平治疗组最常见的不良事件（>= 15%的患者）是疲劳（20.0%）、头晕（17.6%）和恶心（16.5%）；超过15%的安慰剂治疗患者未发生不良事件。结论：总体而言，奥卡西平是安全的，耐受性良好；然而，奥卡西平在偏头痛的预防性治疗中没有显示出疗效。
Objective: To evaluate the efficacy, safety, and tolerability of oxcarbazepine (1,200 mg/day) vs placebo as prophylactic therapy for patients with migraine headaches.Methods: This multicenter, double-blind, randomized, placebo-controlled, parallel-group trial consisted of a 4-week single-blind baseline phase and a 15-week double-blind phase consisting of a 6-week titration period, an 8-week maintenance period, and a 1-week down-titration period, after which patients could enter a 13-week open-label extension phase. During the 6-week titration period, oxcarbazepine was initiated at 150mg/day and increased by 150mg/day every 5 days to a maximum tolerated dose of 1,200 mg/day. The primary outcome measure was change from baseline in the number of migraine attacks during the last 28-day period of the double-blind phase.Results: Eighty-five patients were randomized to receive oxcarbazepine and 85 to receive placebo. There was no difference between the oxcarbazepine (- 1.30) and placebo groups in mean change in number of migraine attacks from baseline during the last 28 days of double-blind phase (-1.74; p = 0.2274). Adverse events were reported for 68 oxcarbazepine-treated patients (80%) and 55 placebo-treated patients (65%). The majority of adverse events were mild or moderate in severity. The most common adverse events (>= 15% of patients) in the oxcarbazepine-treated group were fatigue (20.0%), dizziness (17.6%), and nausea (16.5%); no adverse event occurred in more than 15% of the placebo-treated patients.Conclusions: Overall, oxcarbazepine was safe and well tolerated; however, oxcarbazepine did not show efficacy in the prophylactic treatment of migraine headaches.