Ghose K, Niven B
Department of Pharmacology, University of Otago, Dunedin, New Zealand.
Methods Find Exp Clin Pharmacol. 1998 May;20(4):353-9. doi: 10.1358/mf.1998.20.4.485692.
We assessed the efficacy of sodium valproate as a prophylactic agent in migraine headache. A prospective randomized study was conducted in adult patients who previously derived no significant benefit from most conventional prophylactic therapy for migraine. Twenty-seven patients with a diagnosis of migraine with aura or migraine without aura from a headache clinic received low dose sodium valproate for 3 months. Response to therapy was defined as 50% or greater reduction in the frequency of headache. Plasma drug level monitoring helped to identify four noncompliers who were excluded from the study. Seventeen (71%) patients observed improvement within 4-6 weeks of medication and remained well for 12 weeks. They were further followed up for 12-24 months. Two patients for side effects and 1 for nondrug-related problems were withdrawn from follow-up study. Twelve patients (60%) maintained their response for 12 months or longer. Clinical improvement (percentage reduction in the frequency of migraine attacks) correlated inversely with the plasma drug levels at 13-24 months and daily dose of valproate, among the responders, suggestive of a possible therapeutic window. In other words, patients who do not respond to low dose valproate are unlikely to benefit from further increase in dosage.
我们评估了丙戊酸钠作为偏头痛预防性药物的疗效。对成年患者进行了一项前瞻性随机研究，这些患者此前未从大多数传统偏头痛预防性治疗中获得显著益处。来自头痛诊所的27名诊断为伴有先兆偏头痛或无先兆偏头痛的患者接受了低剂量丙戊酸钠治疗3个月。治疗反应定义为头痛频率降低50%或更多。血浆药物水平监测有助于识别4名未遵医嘱者，他们被排除在研究之外。17名（71%）患者在用药4 - 6周内观察到病情改善，并在12周内保持良好状态。他们进一步随访了12 - 24个月。2名因副作用和1名因非药物相关问题退出了随访研究。12名患者（60%）在12个月或更长时间内维持了治疗反应。在有反应者中，临床改善（偏头痛发作频率降低的百分比）与13 - 24个月时的血浆药物水平和丙戊酸钠的每日剂量呈负相关，提示可能存在治疗窗。换句话说，对低剂量丙戊酸钠无反应的患者不太可能从进一步增加剂量中获益。
