Schuh-Hofer Sigrid, Reuter Uwe, Kinze Stephan, Einhäupl Karl Max, Arnold Guy
Dept. of Neurology, Charité, Berlin, Germany.
J Neurol. 2002 Jan;249(1):94-9. doi: 10.1007/pl00007854.
We investigated the efficacy and tolerability of 20 mg sumatriptan nasal spray in the acute treatment of cluster headache attacks in an open-label study. 10 patients met the criteria of the International Headache Society (IHS) for episodic or chronic cluster headache and were enrolled in our study. The primary efficacy measure was "pain free" 30 minutes after treatment. Secondary end-points included "headache response" (defined as headache improvement from "very severe", "severe" or moderate" pain to "mild" or "no" pain) 15, 30, 45 and 60 minutes after treatment. We also assessed the participant's overall treatment satisfaction at the end of the study. Sumatriptan nasal spray was applied in 154 "moderate" to "very severe" cluster headache attacks. 30 minutes after nasal spray application, 50% of attacks were completely aborted and 58% of attacks responded to treatment. The overall efficacy of sumatriptan nasal spray was considered "excellent" in two, "good" in four, "reasonable" in two and "poor" in two patients. Eight patients indicated their intention to treat further attacks with intranasal sumatriptan. Seven patients were interviewed after a follow-up period of six months. Four patients continued to treat all cluster headache attacks with the intranasal sumatriptan formula, two patients had switched to subcutaneous sumatriptan and one patient was in remission since the end of the study. We conclude that 20 mg sumatriptan nasal spray might be an alternative therapy for the treatment of cluster headache attacks, but double-blind studies are needed to further evaluate its efficacy.
在一项开放标签研究中，我们调查了20毫克舒马曲坦鼻喷雾剂在丛集性头痛发作急性治疗中的疗效和耐受性。10名符合国际头痛协会（IHS）发作性或慢性丛集性头痛标准的患者被纳入我们的研究。主要疗效指标是治疗后30分钟“无痛”。次要终点包括治疗后15、30、45和60分钟的“头痛缓解”（定义为头痛从“非常严重”、“严重”或“中度”疼痛改善为“轻度”或“无”疼痛）。我们还在研究结束时评估了参与者的总体治疗满意度。舒马曲坦鼻喷雾剂应用于154次“中度”至“非常严重”的丛集性头痛发作。鼻喷雾剂应用后30分钟，50%的发作完全中止，58%的发作对治疗有反应。两名患者的舒马曲坦鼻喷雾剂总体疗效被认为“极佳”，四名患者为“良好”，两名患者为“尚可”，两名患者为“较差”。八名患者表示打算用鼻内舒马曲坦治疗进一步发作。随访六个月后对七名患者进行了访谈。四名患者继续用鼻内舒马曲坦配方治疗所有丛集性头痛发作，两名患者已改用皮下注射舒马曲坦，一名患者自研究结束后已缓解。我们得出结论，20毫克舒马曲坦鼻喷雾剂可能是治疗丛集性头痛发作的一种替代疗法，但需要进行双盲研究以进一步评估其疗效。
