Department of Neurology, Ziv Medical Center, Safed, Israel.
Acta Neurol Scand. 2011 Apr;123(4):257-65. doi: 10.1111/j.1600-0404.2010.01394.x.
This preliminary study was designed to evaluate the efficacy and safety of intravenous sodium valproate in managing severe migraine headache.
DESIGN/METHODS: In a preliminary prospective open-label study, we treated patients with severe migraine headache using intravenous sodium valproate, after obtaining written informed consent. Thirty-six patients, hospitalized with acute established migraine, were infused with sodium valproate. The diagnosis of migraine was based on the International Headache Society classification criteria. Severity of headache was reported on 10-point visual analog. Disability was assessed on a five-point scale. Primary and secondary endpoints were measured as sustained pain relief and symptoms improvement at 2 h, respectively.
The study participants had a mean±SD age of 35.7±9.3 years. The loading dose of sodium valproate was 900-1200 mg, and the average time to best response for headache severity was 50 min. A reduction in pain from severe or moderate to mild or no pain in 60 min was reported in 75% of patients [OR=7.187 (95% confidence intervals: 1.32-38.95)]. After treatment with sodium valproate, headache severity was significantly decreased (P<0.0001). No serious adverse events were reported.
Intravenous Sodium Valproate (iVPA) seems to be safe and rapidly effective for intractable migraine attack. Randomized, double-blinded, controlled studies are warranted.
本初步研究旨在评估静脉用丙戊酸钠治疗严重偏头痛头痛的疗效和安全性。
设计/方法:在一项初步前瞻性开放标签研究中,我们在获得书面知情同意后,使用静脉用丙戊酸钠治疗急性确诊偏头痛的住院患者。36 名患有严重偏头痛的患者接受了丙戊酸钠输注。偏头痛的诊断基于国际头痛协会分类标准。头痛严重程度通过 10 分视觉模拟评分报告。残疾程度通过五分制评估。主要和次要终点分别测量为 2 小时时持续缓解疼痛和症状改善。
研究参与者的平均年龄±SD 为 35.7±9.3 岁。丙戊酸钠的负荷剂量为 900-1200mg,头痛严重程度的最佳反应平均时间为 50 分钟。60 分钟内 75%的患者(OR=7.187(95%置信区间:1.32-38.95))报告疼痛从严重或中度减轻到轻度或无痛。静脉用丙戊酸钠治疗后,头痛严重程度显著降低(P<0.0001)。未报告严重不良事件。
静脉用丙戊酸钠(iVPA)似乎对难治性偏头痛发作安全且快速有效。需要进行随机、双盲、对照研究。