Gruffydd-Jones K, Hood C A, Price D B
The Surgery, Chippenham, Wiltshire, UK.
Cephalalgia. 1997 Feb;17(1):31-6. doi: 10.1046/j.1468-2982.1997.1701031.x.
This study compared, for the first time in the United Kingdom, the efficacy and safety of oral 100 mg and subcutaneous 6 mg sumatriptan within a patient for the acute treatment of migraine. The patient's preference for the two formulations of sumatriptan were also recorded. The study was a multicentre, randomized, open, crossover design with an optional open parallel group extension. Individual attacks were treated with one formulation only. Over 70% of patients who treated attack 1 in both treatment periods of the crossover phase reported headache relief with each formulation at 4 h. Only 3% of patients failed to respond to at least one of the formulations at this time point. At the end of the crossover phase patient preference for the injection more than doubled from the pretreatment level in those patients who were previously naive to sumatriptan. During the optional phase of the study, 38% of patients chose to treat some attacks with oral and some with subcutaneous sumatriptan. The main reason for choosing injection was speed of relief, whilst convenience was the major reason for the use of the tablet.
在英国,本研究首次比较了患者使用口服100毫克舒马曲坦和皮下注射6毫克舒马曲坦急性治疗偏头痛的疗效和安全性。同时记录了患者对两种舒马曲坦制剂的偏好。该研究采用多中心、随机、开放、交叉设计,并可选择开放平行组扩展。每次发作仅用一种制剂治疗。在交叉阶段的两个治疗期内,超过70%治疗第1次发作的患者报告在4小时时每种制剂都能缓解头痛。此时,只有3%的患者对至少一种制剂无反应。在交叉阶段结束时,对于之前未使用过舒马曲坦的患者,其对注射剂的偏好较治疗前水平增加了一倍多。在研究的可选阶段,38%的患者选择用口服舒马曲坦治疗一些发作,用皮下注射舒马曲坦治疗另一些发作。选择注射的主要原因是缓解速度快,而使用片剂的主要原因是方便。