Ashrafi M R, Shabanian R, Zamani G R, Mahfelati F
Department of Pediatric Neurology, Tehran University of Medical Sciences, Children's Medical Center, 62 Gharib Street, 14194 Tehran, Iran.
Eur J Paediatr Neurol. 2005;9(5):333-8. doi: 10.1016/j.ejpn.2005.05.004. Epub 2005 Aug 24.
In a randomized clinical trial the effect of Sodium Valproate in pediatric migraine prophylaxis was compared with that of Propranolol. One hundred and twenty patients with common migraine (migraine without aura) aged from 3 to 15 years who met the defined criteria enrolled into the study. Randomly the patients were divided in two groups of A and B, treating with sodium Valproate and Propranolol, respectively. Three phases of baseline period (phase I), titration and adjustment period (phases II) and fixed -dose treatment period (phase III) have been designed. A total of 57 patients in group A, and 58 patients in group B completed all phases of the trial. Seventy two percent of patients in group A and 69% of patients in group B have responded to Sodium Valproate and Propranolol, respectively, as a reduction of more than 50% in headache frequency per month. Further more both drugs have shown efficacy in reducing the severity and duration of headache and also better response to rescue medications (p value <0.01). There was no significant difference in all previously mentioned therapeutic effects between two groups (p value <0.05).
在一项随机临床试验中，将丙戊酸钠用于儿童偏头痛预防的效果与普萘洛尔进行了比较。120名年龄在3至15岁之间、符合既定标准的普通偏头痛（无先兆偏头痛）患者纳入了该研究。患者被随机分为A组和B组，分别接受丙戊酸钠和普萘洛尔治疗。设计了三个阶段，即基线期（第一阶段）、滴定和调整期（第二阶段）以及固定剂量治疗期（第三阶段）。A组共有57名患者，B组共有58名患者完成了试验的所有阶段。A组72%的患者和B组69%的患者对丙戊酸钠和普萘洛尔有反应，即每月头痛频率降低超过50%。此外，两种药物在减轻头痛的严重程度和持续时间方面均显示出疗效，并且对急救药物的反应更好（p值<0.01）。两组之间在所有上述治疗效果方面均无显著差异（p值<0.05）。
