Jensen K, Tfelt-Hansen P, Hansen E W, Krøis E H, Pedersen O S
Department of Neurology, Bispebjerg Hospital, Copenhagen, Denmark.
Cephalalgia. 1995 Oct;15(5):423-9. doi: 10.1046/j.1468-2982.1995.1505423.x.
A novel self-injector for the administration of subcutaneous sumatriptan in the treatment of migraine attacks was tested in 138 patients recruited by family physicians in Denmark: 108 patients completed the initial double-blind, crossover part of the study. Sumatriptan 6 mg s.c. was significantly better than placebo at 30, 60, 90 and 120 min after injection in relieving moderate or severe headache to mild or none as well as relieving any headache to none. At 60 min after injection, the treatment response rate was 61% for sumatriptan and 6% for placebo. During the following open-phase trial of four attacks treated with sumatriptan, treatment response rates were 68-74%. During the total of 538 attacks treated, 12 attempts at using the self-injector failed. In the double-blind and open phases, 81% and 90% of patients respectively found the device easy or very easy to use. Adverse effects were benign and short-lasting, but led seven patients to discontinue the study. In conclusion, subcutaneous sumatriptan administered with a novel self-injector is an effective treatment for migraine compared to placebo in patients treated by their family physician.
一种用于皮下注射舒马曲坦治疗偏头痛发作的新型自动注射器在丹麦由家庭医生招募的138名患者中进行了测试：108名患者完成了研究的初始双盲、交叉部分。皮下注射6毫克舒马曲坦在注射后30、60、90和120分钟时，在将中度或重度头痛缓解为轻度或无头痛以及将任何头痛缓解为无头痛方面明显优于安慰剂。注射后60分钟时，舒马曲坦的治疗有效率为61%，安慰剂为6%。在随后用舒马曲坦治疗的4次发作的开放期试验中，治疗有效率为68 - 74%。在总共治疗的538次发作中，有12次使用自动注射器失败。在双盲和开放阶段，分别有81%和90%的患者认为该装置易于使用或非常易于使用。不良反应为良性且持续时间短，但导致7名患者退出研究。总之，与安慰剂相比，在家庭医生治疗的患者中，使用新型自动注射器皮下注射舒马曲坦是一种有效的偏头痛治疗方法。
