酮咯酸、舒马曲坦与安慰剂鼻喷雾剂（KSPN）治疗急性偏头痛的随机试验
A Randomized Trial of Ketorolac vs. Sumatripan vs. Placebo Nasal Spray (KSPN) for Acute Migraine.
作者信息
Rao Aruna S, Gelaye Bizu, Kurth Tobias, Dash Paul D, Nitchie Haley, Peterlin B Lee
机构信息
Johns Hopkins University School of Medicine, Department of Neurology, Baltimore, MD, USA.
Harvard T.H. Chan School of Public Health, Department of Epidemiology, Boston, MA, USA.
出版信息
Headache. 2016 Feb;56(2):331-40. doi: 10.1111/head.12767. Epub 2016 Feb 3.
OBJECTIVE
To compare the efficacy of ketorolac nasal spray (NS) vs. placebo and sumatriptan NS for the acute treatment of migraine.
METHODS
This was a randomized, double-blind, placebo and active-comparator, crossover study. Adult migraineurs were randomized to ketorolac NS 31.5 mg, sumatriptan NS 20 mg, or placebo to treat three moderate to severe migraine attacks and switched treatments with each attack. Patients seeking headache care at a headache center or in response to community advertisement were recruited. Adult participants with episodic migraine who experienced ≥2 migraine attacks per month were eligible for the Ketorolac vs. Sumatriptan vs. Placebo Nasal Spray migraine study. Participants were randomized to treatment arms by a research pharmacist, in a 1:1:1 ratio using computer-generated lists. The primary outcome was 2-hour pain relief. Secondary outcomes included 2-hour pain freedom and absence of migraine associated symptoms, and 24-hour sustained pain relief and pain freedom.
RESULTS
Of the 72 randomized participants, 54 (75%) treated at least one attack and 49 (68%) completed all three treatments, for a total of 152 treated migraine attacks. Both ketorolac NS (72.5%, P < .001) and sumatriptan NS (69.4%, P = .001) were more effective than placebo (38.3%) for 2-hour pain relief and 2-hour pain freedom (ketorolac: 43.1%, P = .004; sumatriptan: 36.7%, P = .046; placebo: 18.4%). Ketorolac NS, but not sumatriptan NS, was more effective than placebo in 2-hour absence of nausea. Both ketorolac NS and sumatriptan NS were more effective than placebo for 24-hour sustained pain relief (ketorolac: 49%, P < .001; sumatriptan: 31%, P = .01, placebo: 20%). Only ketorolac NS was superior to placebo for 24-hour (ketorolac: 35.3%, P = .003; sumatriptan: 22.4%, P = .18, placebo: 12.2%) sustained pain freedom. Nasal burning and dysgeusia were the most common adverse effects for active treatments.
CONCLUSIONS
This study supports that ketorolac NS is superior to placebo and that it is non-inferior to sumatriptan NS for the acute abortive treatment of migraine.
目的
比较酮咯酸鼻喷雾剂（NS）与安慰剂及舒马曲坦鼻喷雾剂用于偏头痛急性治疗的疗效。
方法
这是一项随机、双盲、安慰剂和活性对照交叉研究。成年偏头痛患者被随机分为接受31.5毫克酮咯酸鼻喷雾剂、20毫克舒马曲坦鼻喷雾剂或安慰剂治疗三次中度至重度偏头痛发作，每次发作更换治疗药物。招募在头痛中心寻求头痛治疗或因社区广告而来的患者。每月经历≥2次偏头痛发作的发作性偏头痛成年参与者符合酮咯酸与舒马曲坦与安慰剂鼻喷雾剂偏头痛研究的条件。研究药剂师使用计算机生成的列表以1:1:1的比例将参与者随机分配至各治疗组。主要结局为2小时疼痛缓解。次要结局包括2小时无痛及无偏头痛相关症状，以及24小时持续疼痛缓解和无痛。
结果
72名随机分组的参与者中，54名（75%）至少治疗了一次发作，49名（68%）完成了所有三次治疗，共治疗了152次偏头痛发作。酮咯酸鼻喷雾剂（72.5%，P <.001）和舒马曲坦鼻喷雾剂（69.4%，P =.001）在2小时疼痛缓解和2小时无痛方面均比安慰剂（38.3%）更有效（酮咯酸：43.1%，P =.
004；舒马曲坦：36.7%，P =.046；安慰剂：18.4%）。酮咯酸鼻喷雾剂在2小时无恶心方面比安慰剂更有效，但舒马曲坦鼻喷雾剂则不然。酮咯酸鼻喷雾剂和舒马曲坦鼻喷雾剂在24小时持续疼痛缓解方面均比安慰剂更有效（酮咯酸：49%，P <.001；舒马曲坦：31%，P =.01，安慰剂：20%）。仅酮咯酸鼻喷雾剂在24小时持续无痛方面优于安慰剂（酮咯酸：35.3%，P =.003；舒马曲坦：22.4%，P =.18，安慰剂：12.2%）。鼻内烧灼感和味觉障碍是活性治疗最常见的不良反应
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