Göbel H, Stolze H, Heinze A, Dworschak M, Heuss D, Christiani K, Lindner V
Klinik für Neurologie der Christian-Albrechts-Universität, Kiel.
Nervenarzt. 1996 Jun;67(6):471-83.
The aim of the open prospective study was to investigate the efficacy, safety and tolerability of subcutaneous sumatriptan in acute migraine treatment. Patient self-treatment was monitored over a time period of 6-18 months with 6 mg of sumatriptan administered subcutaneously by an autoinjector. In total, 2,263 patients participated in the study. Headache intensity was documented by the patient in a headache diary before and 1 and 2 h after application. During the study period from October 1991 to June 1993, 43,691 migraine attacks were investigated. Treatment with sumatriptan was efficient in 89.5% of the attacks. Headache relief was achieved in 71%. Headache reoccurred in 22.7% of the attacks, and therefore a second injection was administered. An intraindividual treatment efficacy of 80-100% was achieved in 82.9% of the patients. During long-term treatment the ratio of effective treatment and headache frequency was constant; 4.9% of the patients withdrew from the study because of adverse events and because they felt the treatment was not effective. A total of 44.5% of the patients reported adverse events that were serious in 1.7%. Subcutaneous self-treatment with sumatriptan in the acute treatment of migraine is effective and well tolerated by the patients.
这项开放性前瞻性研究的目的是调查皮下注射舒马曲坦治疗急性偏头痛的疗效、安全性和耐受性。在6至18个月的时间段内,对患者的自我治疗进行监测,使用自动注射器皮下注射6毫克舒马曲坦。共有2263名患者参与了该研究。患者在用药前、用药后1小时和2小时通过头痛日记记录头痛强度。在1991年10月至1993年6月的研究期间,共调查了43691次偏头痛发作。舒马曲坦治疗对89.5%的发作有效。71%的患者头痛得到缓解。22.7%的发作头痛复发,因此进行了第二次注射。82.9%的患者个体内治疗有效率达到80-100%。在长期治疗期间,有效治疗与头痛频率的比例保持不变;4.9%的患者因不良事件和感觉治疗无效而退出研究。共有44.5%的患者报告了不良事件,其中1.7%为严重不良事件。皮下自我注射舒马曲坦治疗急性偏头痛有效且患者耐受性良好。