Tanen David A, Miller Sharon, French Tonianne, Riffenburgh Robert H
Department of Emergency Medicine, Naval Medical Center San Diego, San Diego, CA 92134, USA.
Ann Emerg Med. 2003 Jun;41(6):847-53. doi: 10.1067/mem.2003.195.
We compare the efficacy of intravenous sodium valproate versus prochlorperazine for the emergency department treatment of acute migraine headache.
We performed a randomized, prospective, double-blind trial performed at a tertiary care military ED. Forty patients, aged 18 to 65 years, presenting with typical migraine symptoms were enrolled. Patients were randomized to receive either 10 mg of prochlorperazine or 500 mg of valproate intravenously over 2 minutes. Pain, nausea, and sedation were assessed by using a standard visual analog scale (VAS). Changes in VAS scores were compared between groups from baseline to end point by using a rank sum test, over time by using 2-way repeated-measures analysis of variance, and by requirement for rescue at 60 minutes by using the Fisher exact test.
Comparison of the change in median VAS scores over 60 minutes revealed that sodium valproate was significantly less effective than prochlorperazine in reducing pain or nausea (P <.001). Median improvements in VAS pain scores (binomial confidence intervals) were as follows: 64.5 mm (48.1 to 75.6 mm) for prochlorperazine versus 9 mm (-3 to 39.6 mm) for sodium valproate. Median improvements in VAS nausea scores were as follows: 35.5 mm (13.2 to 47.9 mm) for prochlorperazine versus 2 mm (-1.3 to 11 mm) for sodium valproate. There was no significant difference (P =.603) detected in the median changes in VAS scores for sedation: -4 mm (-29.9 to 8.6 mm) for prochlorperazine versus 0 mm (-6.6 to 6 mm) for sodium valproate. Comparison of the mean VAS time curves for pain and nausea also demonstrated a significant difference (both P <.001) but not for sedation (P =.232). In post hoc analysis, valproate failed to elicit significant improvement in pain or nausea scores over time, whereas prochlorperazine improved pain by 30 minutes (P <.001) and nausea by 15 minutes (P =.002). At the conclusion of the study, 15 (79%) of 19 patients receiving valproate required rescue treatment compared with 5 (25%) of 20 patients receiving prochlorperazine (P <.001).
Prochlorperazine was statistically and clinically superior to sodium valproate for the treatment of the pain and nausea associated with acute migraine headaches.
我们比较静脉注射丙戊酸钠与氯丙嗪在急诊科治疗急性偏头痛的疗效。
我们在一家三级医疗军事急诊科进行了一项随机、前瞻性、双盲试验。纳入40名年龄在18至65岁、表现出典型偏头痛症状的患者。患者被随机分为两组，分别在2分钟内静脉注射10mg氯丙嗪或500mg丙戊酸钠。使用标准视觉模拟量表（VAS）评估疼痛、恶心和镇静情况。使用秩和检验比较两组从基线到终点VAS评分的变化，使用双向重复测量方差分析比较随时间的变化，并使用Fisher精确检验比较60分钟时的急救需求。
比较60分钟内VAS评分中位数的变化发现，丙戊酸钠在减轻疼痛或恶心方面明显不如氯丙嗪有效（P<.001）。VAS疼痛评分的中位数改善情况（二项式置信区间）如下：氯丙嗪为64.5mm（48.1至75.6mm），丙戊酸钠为9mm（-3至39.6mm）。VAS恶心评分的中位数改善情况如下：氯丙嗪为35.5mm（13.2至47.9mm），丙戊酸钠为2mm（-1.3至11mm）。在镇静的VAS评分中位数变化方面未检测到显著差异（P=.603）：氯丙嗪为-4mm（-29.9至8.6mm），丙戊酸钠为0mm（-6.6至6mm）。疼痛和恶心的平均VAS时间曲线比较也显示出显著差异（均P<.001），但镇静方面无差异（P=.232）。在事后分析中，丙戊酸钠随时间推移未能使疼痛或恶心评分有显著改善，而氯丙嗪在30分钟时疼痛改善（P<.001），15分钟时恶心改善（P=.002）。在研究结束时，接受丙戊酸钠治疗的19名患者中有15名（79%）需要急救治疗，而接受氯丙嗪治疗的20名患者中有5名（25%）需要急救治疗（P<.001）。
在治疗与急性偏头痛相关的疼痛和恶心方面，氯丙嗪在统计学和临床上均优于丙戊酸钠。
