急诊科急性偏头痛发作时静脉注射布洛芬与丙戊酸钠的对比：一项随机临床试验。

Intravenous ibuprofen versus sodium valproate in acute migraine attacks in the emergency department: A randomized clinical trial.

作者信息

Dogruyol Sinem, Gur Sultan Tuna Akgol, Akbas Ilker, Kocak Meryem Betos, Kocak Abdullah Osman, Ceylan Mustafa, Tekyol Davut

机构信息

Department of Emergency Medicine, Haydarpasa Numune Training and Research Hospital, Istanbul, Turkey.

Department of Emergency Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey.

出版信息

Am J Emerg Med. 2022 May;55:126-132. doi: 10.1016/j.ajem.2022.02.046. Epub 2022 Mar 4.

DOI:10.1016/j.ajem.2022.02.046

PMID:35313227

Abstract

OBJECTIVE

Sodium valproate and ibuprofen are drugs with known efficacy in the treatment of headache associated with acute migraine attacks. In this study, our aim was to compare the efficacy of these two drugs in the treatment of acute migraine attacks when administered as a single intravenous (IV) dose in the emergency department.

MATERIALS AND METHOD

This study was designed as a prospective, randomized controlled, double-blinded study and included patients aged 18 to 65 years who presented to the emergency department with acute headache and met the criteria of 'migraine without aura' according to the International Classification of Headache Disorders. The patients were randomized into two groups and given a single dose of 800 mg sodium valproate or 800 mg ibuprofen in 150 mL of normal saline by IV infusion over five minutes. Changes in pain levels were assessed using the Numerical Rating Scale (NRS) for pain over a two-hour period.

RESULTS

Ninety-nine patients (49 patients in the sodium valproate group and 50 in the ibuprofen group) completed the trial, and their data were included in the statistical analysis. The mean decrease in the post-treatment delta NRS values was statistically significantly higher in the sodium valproate group than in the ibuprofen group. The mean differences were 1.69 [confidence interval (CI): 1.02-2.37, p<0.001], the mean difference between N0 and N2 was 3.61 (CI: 2.96-4.26, p < 0.001), the mean difference between N0 and N3 was 4.11 (CI: 3.54-4.67, p < 0.001), and the mean difference between N0 and N4 was 3.92 (CI: 3.67-4.46, p < 0.001). The number of patients who achieved the primary endpoint of pain relief was significantly higher in the sodium valproate group than in the ibuprofen group (p < 0.001). According to the Kaplan-Meier analysis showing the rates of reaching the targeted endpoint, there was a significant difference in the efficacy of the two-treatment group (χ2 = 79.98, CI: 80.35-99.65; p = 0.000).

摘要

目的

丙戊酸钠和布洛芬是已知对治疗与急性偏头痛发作相关的头痛有效的药物。在本研究中，我们的目的是比较这两种药物在急诊科单次静脉注射给药时治疗急性偏头痛发作的疗效。

材料与方法

本研究设计为一项前瞻性、随机对照、双盲研究，纳入年龄在18至65岁之间、因急性头痛就诊于急诊科且符合《国际头痛疾病分类》中“无先兆偏头痛”标准的患者。将患者随机分为两组，通过静脉输注在五分钟内给予单剂量800毫克丙戊酸钠或800毫克布洛芬于150毫升生理盐水中。使用数字疼痛评分量表（NRS）在两小时内评估疼痛水平的变化。

结果

99名患者（丙戊酸钠组49名患者，布洛芬组50名患者）完成了试验，其数据纳入统计分析。丙戊酸钠组治疗后NRS差值的平均下降在统计学上显著高于布洛芬组。平均差值为1.69[置信区间（CI）：1.02 - 2.37，p<0.001]，N0与N指的是什么意思未翻译出来，原文中N0与N2之间的平均差值为3.61（CI：2.96 - 4.26，p < 0.001），N0与N3之间的平均差值为4.11（CI：3.54 - 4.67，p < 0.001），N0与N4之间的平均差值为3.92（CI：3.67 - 4.46，p < 0.001）。达到疼痛缓解主要终点的患者数量在丙戊酸钠组显著高于布洛芬组（p < 0.001）。根据显示达到目标终点率的Kaplan - Meier分析，两组治疗的疗效存在显著差异（χ2 = 79.98，CI：80.35 - 99.65；p = 0.000）。