罗非考昔在急性偏头痛治疗中的作用:一项随机对照临床试验  

Rofecoxib in the acute treatment of migraine: A randomized controlled clinical trial

作　　者：Saper J. Dahlof C. So Y C. Lines 樊慧婷 

机构地区：[1]Merck and Co., Inc., PO Box 4, West Point, PA 19486, United States Dr.

出　　处：《世界核心医学期刊文摘（神经病学分册）》2006年第9期51-51,共1页Digest of the World Core Medical Journals:Clinical Neurology

摘　　要：Objective. -To investigate the efficacy, tolerability, and safety of rofecoxib and ibuprofen for acute migraine treatment. Background. -Rofecoxib was effective and well tolerated in a previous study of treatment of a single migraine attack. We sought to replicate these findings for a single attack and also study the clinical profile of rofecoxib in the acute treatment of multiple migraine attacks. Ibuprofen was included as a reference nonselective NSAID. Methods. -Adult migraineurs (n = 783) treated one migraine attack with either rofecoxib (25 or 50 mg), ibuprofen 400 mg, or placebo in a randomized, double-blind study. Patients could elect to enroll in a 3-month double-blind extension phase. Results. -In the single-attack phase, headache relief at 2 hours postdose was reported by 59.4%, 62.2%, and 57.7%of patients who took rofecoxib 25 mg, rofecoxib 50 mg, and ibuprofen 400 mg, respectively, versus 30.5%for placebo (all P < .001 vs placebo). The active drugs were statistically superior to placebo on a variety of additional measures. In the extension phase, the mean percentage of patients‘attacks with headache relief at 2 hours postdose was 61.8%for rofecoxib 25 mg, 65.4%for rofecoxib 50 mg, and 59.3%for ibuprofen 400 mg. The mean percentage of patients’attacks with 24-hour sustained headache relief was greater for rofecoxib 50 mg (52.0%) than for rofecoxib 25 mg (47.8%, P < .050) or ibuprofen (39.0%, P < .010). In the single-attack phase, the adverse event rate was higher for rofecoxib 50 mg (37.8%) than placebo (27.8%, P < .050); rates were similar to placebo for rofecoxib 25 mg (32.0%, n.s.) and ibuprofen 400 mg (28.1%, n.s.). In the extension phase, treatment groups had similar adverse event rates. Conclusions. -Rofecoxib 25 and 50 mg and ibuprofen 400 mg were effective and generally well tolerated in the acute treatment of migraine.Objective. -To investigate the efficacy, tolerability, and safety of rofecoxib and ibuprofen for acute migraine treatment. Background. -Rofecoxib was effective and well tolerated in a previous study of treatment of a single migraine attack. We sought to replicate these findings for a single attack and also study the clinical profile of rofecoxib in the acute treatment of multiple migraine attacks. Ibuprofen was included as a reference nonselective NSAID. Methods. -Adult migraineurs （n = 783） treated one migraine attack with either rofecoxib （25 or 50 mg）, ibuprofen 400 mg, or placebo in a randomized, double-blind study. Patients could elect to enroll in a 3-month double-blind extension phase. Results. -In the single-attack phase, headache relief at 2 hours postdose was reported by 59.4%, 62. 2%, and 57.7% of patients who took rofecoxib 25 rag, rofecoxib 50 rag, and ibuprofen 400 rag, respectively, versus 30.5% for placebo （all P 〈. 001 vs placebo）. The active drugs were statistically superior to placebo on a variety of additional measures. In the extension phase, the mean percentage of patients＇ attacks with headache relief at 2 hours postdose was 61.8% for rofecoxib 25 rag, 65.4% for rofecoxib 50 mg, and 59.3% for ibuprofen 400 mg. The mean percentage of patients＇ attacks with 24-hour sustained headache relief was greater for rofecoxib 50 mg （52.0%） than for rofecoxib 25 mg （47.8%, P 〈. 050） or ibuprofen （39.0%, P 〈. 010） .

关 键 词：随机对照临床试验 偏头痛治疗 罗非考昔 急性 非甾体类抗炎药 头痛发作 偏头痛患者 随机双盲研究 

分 类 号：R560.5[医药卫生—呼吸系统]