Akpunonu B E, Mutgi A B, Federman D J, Volinsky F G, Brickman K, Davis R L, Gilbert C, Asgharnejad M
Department of Internal Medicine, Medical College of Ohio, Toledo.
Ann Emerg Med. 1995 Apr;25(4):464-9. doi: 10.1016/s0196-0644(95)70259-8.
To assess the efficacy of SC sumatriptan injection versus placebo in the treatment of acute migraine in ED patients and that of open-label 100 mg sumatriptan PO tablets for recurrent migraine.
Randomized, double-blind, placebo-controlled, multi-center trial.
Twelve EDs in the United States.
Adult patients presenting to the ED from September 1992 through April 1993 with a diagnosis of migraine as determined by International Headache Society criteria. Patients were randomized to receive 6 mg sumatriptan SC or placebo. Patients were monitored for improvement in headache severity using a four-point scale and for time to meaningful relief using a stopwatch. The time to discharge from the ED was recorded. An open-label 100 mg sumatriptan PO tablet was given to all patients on discharge from the ED for use at home if the headache recurred within 24 hours.
One hundred thirty-six patients were enrolled. Seventy-five percent of patients treated with sumatriptan achieved meaningful relief compared with 35% treated with placebo (P < .001). The median time to meaningful relief was 34 minutes in the group that received sumatriptan. Seventy percent of patients in the sumatriptan group versus 35% in the placebo group reported mild or no pain at discharge (P < .001). Migraine-associated symptoms such as nausea, photophobia, and phonophobia were significantly reduced in the sumatriptan group (P < .005). The median time to discharge from the ED was shorter for the sumatriptan group than for the placebo group (60 versus 96 minutes, respectively; P = .001). At baseline, 15% of patients in the sumatriptan group and 19% of patients in the placebo group reported mild or no clinical disability. At the time of discharge, patients with mild or no disability increased to 75% in the sumatriptan group compared with 44% in the placebo group (P = .001). Fifty-seven of 92 patients (62%) with mild or no pain at discharge took open-label oral sumatriptan for headache recurrence, and 37 (65%) experienced meaningful relief within 2 hours. Median time to meaningful relief after oral sumatriptan was 65 minutes.
Sumatriptan (6 mg SC) is effective in treating acute migraine in the ED. Oral sumatriptan (100 mg) is effective in treating headache recurrence within 24 hours.
评估皮下注射舒马曲坦与安慰剂治疗急诊患者急性偏头痛的疗效，以及开放标签的100mg舒马曲坦口服片剂治疗复发性偏头痛的疗效。
随机、双盲、安慰剂对照、多中心试验。
美国的12家急诊科。
1992年9月至1993年4月因偏头痛就诊于急诊科的成年患者，偏头痛诊断依据国际头痛协会标准确定。患者被随机分配接受6mg皮下注射舒马曲坦或安慰剂。使用四点量表监测患者头痛严重程度的改善情况，并用秒表记录达到有效缓解的时间。记录从急诊科出院的时间。所有患者从急诊科出院时均给予100mg开放标签的舒马曲坦口服片剂，以便在家中头痛复发在24小时内时使用。
共纳入136例患者。接受舒马曲坦治疗的患者中有75%达到有效缓解，而接受安慰剂治疗的患者中这一比例为35%（P<0.001）。接受舒马曲坦治疗组达到有效缓解的中位时间为34分钟。舒马曲坦组70%的患者在出院时报告轻度疼痛或无疼痛，而安慰剂组为35%（P<0.001）。舒马曲坦组中与偏头痛相关的症状如恶心、畏光和畏声明显减轻（P<0.005）。舒马曲坦组从急诊科出院的中位时间比安慰剂组短（分别为60分钟和96分钟；P=0.001）。基线时，舒马曲坦组15%的患者和安慰剂组19%的患者报告轻度或无临床功能障碍。出院时，舒马曲坦组轻度或无功能障碍的患者增至75%，而安慰剂组为44%（P=0.001）。92例出院时轻度疼痛或无疼痛的患者中有57例（62%）因头痛复发服用了开放标签的口服舒马曲坦，其中37例（65%）在2小时内达到有效缓解。口服舒马曲坦后达到有效缓解的中位时间为65分钟。
舒马曲坦（6mg皮下注射）治疗急诊科急性偏头痛有效。口服舒马曲坦（100mg）治疗24小时内的头痛复发有效。
