Monstad I, Krabbe A, Micieli G, Prusinski A, Cole J, Pilgrim A, Shevlin P
Nevrologisk avd, Hedmark Sentralsykehus, Elverum, Norway.
Headache. 1995 Nov-Dec;35(10):607-13. doi: 10.1111/j.1526-4610.1995.hed3510607.x.
This multinational, multicenter, randomized, double-blind, placebo-controlled study in 169 patients investigated the effect of a 7-day period of preemptive treatment with oral sumatriptan (100 mg tid) on the frequency and severity of cluster headache attacks occurring during an established cluster headache period. Safety and tolerability were also assessed. Cluster headache patients who were not taking prophylactic medication and had experienced seven or more attacks in the preceding observation week, treated a cluster headache attack at home with subcutaneous sumatriptan 6 mg using an autoinjector device. Patients were then randomized to take sumatriptan 100 mg or placebo at 8-hourly intervals for a 7-day period. Cluster headaches occurring during this period could be treated 5 minutes after onset with rescue medication (100% oxygen or simple analgesics). Diary cards were used to record details of the cluster headache pattern during the observation and study treatment weeks. Preemptive oral treatment with sumatriptan 100 mg tid for 7 days did not produce a significant reduction in the number or severity of cluster headache attacks occurring during an established cluster headache period. Oral treatment with sumatriptan 100 mg tid over a 7-day period was not associated with an increased or altered adverse event profile from that previously reported.
这项针对169名患者的跨国、多中心、随机、双盲、安慰剂对照研究，调查了口服舒马曲坦（100毫克，每日三次）进行7天预防性治疗，对丛集性头痛发作期丛集性头痛发作的频率和严重程度的影响。同时也评估了安全性和耐受性。未服用预防性药物且在前一周观察期内经历过7次或更多次发作的丛集性头痛患者，在家中使用自动注射器装置皮下注射6毫克舒马曲坦治疗丛集性头痛发作。然后，患者被随机分组，每8小时服用一次100毫克舒马曲坦或安慰剂，为期7天。在此期间发作的丛集性头痛可在发作后5分钟用急救药物（100%氧气或简单镇痛药）治疗。在观察期和研究治疗期，使用日记卡记录丛集性头痛模式的详细情况。100毫克舒马曲坦每日三次进行7天预防性口服治疗，并未使在已确定的丛集性头痛发作期发生的丛集性头痛发作次数或严重程度显著减少。100毫克舒马曲坦每日三次进行7天口服治疗，与先前报告的不良事件情况相比，并未增加或改变不良事件情况。
