Mitsikostas D D, Polychronidis I
Athens Naval and Veterans Hospital, Department of Neurology, Greece.
Funct Neurol. 1997 Sep-Oct;12(5):267-76.
The aim of this study was to compare the efficacy and safety of valproate versus flunarizine in migraine prophylaxis in a randomized double-open clinical trial. Twenty-two migraine sufferers were treated with valproate (1 g per day) for 8 weeks; a parallel group of 22 migraine sufferers was treated with flunarizine (10 mg per day). The main admission criterion was a minimum of 3 migraine (with, or without aura) attacks per month. The major clinical parameters evaluated were the frequency of headache attacks, the frequency of use of drugs for the acute management of migraine, the patients' opinion of treatment and the Hamilton anxiety and depression rating scales. During the study 3 patients dropped out (1 from the valproate and 2 from the flunarizine groups). Fifteen patients (71.4%) from the valproate group responded to therapy, compared to 14 patients (65%) from the flunarizine group. In the valproate group 12 patients (57.1%) reported various side effects (prevalently gastric symptoms) versus 10 patients (47.6%) in the flunarizine group (prevalently somnolence). The patients who were treated with flunarizine showed an increase in the mean score of the 21-item Hamilton rating scale for depression, but the difference was not significant; morning dysthymia however, was significantly more often observed in the flunarizine patients, compared to the valproate patients. These results suggest that both drugs are effective and safe in migraine prophylaxis.
本研究旨在通过一项随机双盲临床试验比较丙戊酸盐与氟桂利嗪预防偏头痛的疗效和安全性。22名偏头痛患者接受丙戊酸盐治疗（每日1克），为期8周；另一组22名偏头痛患者作为平行组，接受氟桂利嗪治疗（每日10毫克）。主要入选标准为每月至少发作3次偏头痛（伴或不伴先兆）。评估的主要临床参数包括头痛发作频率、用于偏头痛急性治疗的药物使用频率、患者对治疗的看法以及汉密尔顿焦虑和抑郁评定量表。研究期间，3名患者退出（丙戊酸盐组1名，氟桂利嗪组2名）。丙戊酸盐组15名患者（71.4%）对治疗有反应，而氟桂利嗪组为14名患者（65%）。丙戊酸盐组12名患者（57.1%）报告了各种副作用（主要为胃肠道症状），氟桂利嗪组为10名患者（47.6%）（主要为嗜睡）。接受氟桂利嗪治疗的患者汉密尔顿21项抑郁评定量表平均得分有所增加，但差异不显著；然而，与丙戊酸盐组患者相比，氟桂利嗪组患者晨轻郁症的发生率明显更高。这些结果表明，两种药物在预防偏头痛方面均有效且安全。
