Friedman B W, Corbo J, Lipton R B, Bijur P E, Esses D, Solorzano C, Gallagher E J
Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore Medical Center, 111 E. 210 St., Bronx, NY 10467, USA.
Neurology. 2005 Feb 8;64(3):463-8. doi: 10.1212/01.WNL.0000150904.28131.DD.
To compare the efficacy of 20 mg of IV metoclopramide, given up to four times over 2 hours as needed for persistent headache, with 6 mg of subcutaneous sumatriptan for the emergency department treatment of migraine headaches.
This was a randomized, double-blind, clinical trial with two intervention arms. The primary endpoint was change in pain intensity as measured by an 11-point pain scale at 2 hours. Secondary endpoints included change in pain intensity at 24 hours and rates of pain-free headache relief at 2 and 24 hours.
Two hundred two patients were screened, and 78 of 91 eligible patients were randomized. The two groups had comparable pain scores at baseline. By 2 hours, the change in pain intensity for the metoclopramide group was 7.2 compared with 6.3 for the sumatriptan group (95% CI for difference: -0.2 to 2.2). When compared at 24 hours, the metoclopramide group had improved by 6.1 compared with baseline and the sumatriptan group had improved by 5.0 (95% CI for difference: -0.6 to 2.8). At 2 hours, pain-free rates were 59% in the metoclopramide arm and 35% in the sumatriptan arm (95% CI for difference of 24%: 2 to 46%). The most common side effects at both time points were weakness, dizziness, and drowsiness, which were distributed evenly between the two groups. There were no reports of chest pain within the first 2 hours. The incidence of restlessness, stiffness, and abnormal movements was distributed equally between the two groups.
When compared at 2 and 24 hours, aggressive (20 mg dosed up to four times) IV metoclopramide and 6 mg of subcutaneous sumatriptan relieved migraine headache pain comparably. Some secondary endpoints suggest that metoclopramide may be the preferable therapy for migraines presenting to the emergency department.
比较静脉注射20毫克胃复安（必要时在2小时内给药多达4次以缓解持续性头痛）与皮下注射6毫克舒马曲坦用于急诊科治疗偏头痛的疗效。
这是一项随机、双盲临床试验，设有两个干预组。主要终点是2小时时用11点疼痛量表测量的疼痛强度变化。次要终点包括24小时时的疼痛强度变化以及2小时和24小时时无疼痛性头痛缓解率。
筛查了202例患者，91例符合条件的患者中有78例被随机分组。两组在基线时的疼痛评分相当。到2小时时，胃复安组的疼痛强度变化为7.2，而舒马曲坦组为6.3（差异的95%置信区间：-0.2至2.2）。在24小时时进行比较，胃复安组较基线时改善了6.1，舒马曲坦组改善了5.0（差异的95%置信区间：-0.6至2.8）。在2小时时，胃复安组的无痛率为59%，舒马曲坦组为35%（24%差异的95%置信区间：2至46%）。两个时间点最常见的副作用是虚弱、头晕和嗜睡，在两组中分布均匀。在前2小时内无胸痛报告。不安、僵硬和异常运动的发生率在两组中分布相同。
在2小时和24小时时进行比较，积极给药（20毫克给药多达4次）的静脉注射胃复安和6毫克皮下注射舒马曲坦缓解偏头痛疼痛的效果相当。一些次要终点表明，胃复安可能是急诊科偏头痛的更优治疗方法。
