新型呼吸驱动双向装置经鼻给予舒马曲坦粉治疗偏头痛急性发作的随机、安慰剂对照研究。
Intranasal sumatriptan powder delivered by a novel breath-actuated bi-directional device for the acute treatment of migraine: A randomised, placebo-controlled study.
机构信息
OptiNose AS, Oslo, Norway.
出版信息
Cephalalgia. 2010 Aug;30(8):933-42. doi: 10.1177/0333102409359314. Epub 2010 Mar 17.
INTRODUCTION
Intranasal sumatriptan is an option for the treatment of migraine; however, nasal delivery using conventional spray pumps is suboptimal.
METHODS
Adult subjects (n = 117) with migraine were enrolled in a multicentre, randomised, double-blind, parallel group, placebo-controlled study. A single migraine attack was treated in-clinic with sumatriptan 10 mg, sumatriptan 20 mg or placebo administered intranasally by a novel bi-directional powder delivery device when migraine was moderate or severe.
RESULTS
A greater proportion of subjects who received sumatriptan were pain-free at 120 minutes compared with those who received placebo (10 mg/20 mg sumatriptan vs. placebo = 54%/57% vs. 25%, P < .05). Significant benefits were also observed for pain relief at 120 minutes (84%/80% vs. 44%, P < .001/.01) and as early as 60 minutes (73%/74% vs. 38%, P < .01) and for 48 hours sustained pain-free (P < .05). Treatment-related adverse events were rare, with a metallic taste being the most commonly reported (10%/13%).
CONCLUSIONS
Sumatriptan nasal powder administered using the new device during a migraine attack was effective and well tolerated.
简介
鼻内给予舒马曲坦是治疗偏头痛的一种选择；然而，使用传统喷雾泵进行鼻腔输送的效果并不理想。
方法
患有偏头痛的成年受试者（n=117）参加了一项多中心、随机、双盲、平行组、安慰剂对照研究。在诊所中，当偏头痛处于中度或重度时，使用新型双向粉末输送装置经鼻给予舒马曲坦 10mg、舒马曲坦 20mg 或安慰剂单次治疗偏头痛发作。
结果
与接受安慰剂的受试者相比，接受舒马曲坦治疗的受试者在 120 分钟时无痛的比例更高（10mg/20mg 舒马曲坦 vs. 安慰剂=54%/57% vs. 25%，P<.05）。在 120 分钟时也观察到疼痛缓解的显著益处（84%/80% vs. 44%，P<.001/.01），以及在 60 分钟时（73%/74% vs. 38%，P<.01）和 48 小时持续无痛（P<.05）。治疗相关的不良事件罕见，最常报告的是金属味（10%/13%）。
结论
在偏头痛发作期间使用新设备给予舒马曲坦鼻内粉末是有效且耐受良好的。
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