Randomized trial of IV valproate vs metoclopramide vs ketorolac for acute migraine
Randomized trial of IV valproate vs metoclopramide vs ketorolac for acute migraine
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DOI：
10.1212/wnl.0000000000000223
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发表时间：
2014-03-18
期刊：
影响因子：
9.9
通讯作者：
Gallagher, E. John
中科院分区：
文献类型：
--
作者：
Friedman, Benjamin W.;Garber, Leonid;Gallagher, E. John
目的：我们比较了静脉注射丙戊酸盐与甲氧氯普胺和酮咯酸在急诊科（艾德）急性偏头痛患者中的疗效。方法：这是一项双盲比较疗效试验。患者被随机分配至1,000 mg丙戊酸钠、10 mg甲氧氯普胺或30 mg酮咯酸组，均在15分钟内静脉滴注。主要结局是头痛改善1小时，在基线和60分钟后用0到10分的口头量表测量。重要的次要结果包括：（1）需要在艾德急救药物，和（2）持续头痛freedom.Results：330例患者在2010年10月开始超过30个月。3组之间的基线特征相当。在主要结局方面，接受丙戊酸盐IV治疗的患者在0 - 10量表上平均改善2.8（95%置信区间[CI]：2.3，3.3）;接受甲氧氯普胺IV治疗的患者改善4.7（95% CI：4.2，5.2）;接受酮咯酸IV治疗的患者改善3.9（95% CI：3.3，4.5）。在次要终点方面，69%（95% CI：60%，78%）接受丙戊酸盐治疗的患者需要急救药物，而甲氧氯普胺组为33%（95% CI：24%，42%），酮咯酸组为52%（95% CI：42%，63%）。4%（95% CI：0%，7%）的随机分配至丙戊酸盐组患者、11%（95% CI：5%，17%）的甲氧氯普胺组患者和16%（95% CI：9%，23%）的酮咯酸组患者实现了持续头痛缓解。在甲氧氯普胺组中，6%（95%CI：3%，12%）的患者报告在研究药物给药后感到非常不安。结论：丙戊酸盐的有效性低于甲氧氯普胺或酮咯酸。甲氧氯普胺表现出优于酮咯酸在几个endpoints.Classification的证据：这项研究提供了I类证据，在急性偏头痛的艾德患者，IV丙戊酸盐是劣于甲氧氯普胺或酮咯酸在改善头痛的结果。
Objective:We compared the efficacy of IV valproate with metoclopramide and with ketorolac in patients presenting to an emergency department (ED) with acute migraine.Methods:This was a double-blind comparative efficacy trial. Patients were randomized to 1,000 mg sodium valproate, 10 mg metoclopramide, or 30 mg ketorolac, each administered as an IV drip over 15 minutes. The primary outcome was improvement in headache by 1 hour, measured on a verbal 0 to 10 scale, at baseline and 60 minutes later. Important secondary outcomes included (1) need for rescue medication in the ED, and (2) sustained headache freedom.Results:Three hundred thirty patients were enrolled over 30 months beginning in October 2010. Baseline characteristics were comparable among the 3 arms. On the primary outcome, patients receiving IV valproate improved by a mean of 2.8 (95% confidence interval [CI]: 2.3, 3.3) on the 0 to 10 scale; those receiving IV metoclopramide improved by 4.7 (95% CI: 4.2, 5.2); and those receiving IV ketorolac improved by 3.9 (95% CI: 3.3, 4.5). On the secondary endpoints, 69% (95% CI: 60%, 78%) of patients receiving valproate required rescue medication, compared with 33% (95% CI: 24%, 42%) of metoclopramide patients and 52% (95% CI: 42%, 63%) of those assigned to ketorolac. Sustained headache freedom was achieved in 4% (95% CI: 0%, 7%) of those randomized to valproate, 11% (95% CI: 5%, 17%) of metoclopramide patients, and 16% (95% CI: 9%, 23%) receiving ketorolac. In the metoclopramide arm, 6% (95% CI: 3%, 12%) of patients reported feeling very restless after investigational medication administration.Conclusions:Valproate was less efficacious than either metoclopramide or ketorolac. Metoclopramide demonstrated superiority to ketorolac on several endpoints.Classification of evidence:This study provides Class I evidence that in ED patients with acute migraine, IV valproate is inferior to metoclopramide or ketorolac in improving headache outcomes.