Winner P, Ricalde O, Le Force B, Saper J, Margul B
Palm Beach Headache Center, Fla, USA.
Arch Neurol. 1996 Feb;53(2):180-4. doi: 10.1001/archneur.1996.00550020092020.
To assess the efficacy and tolerability of subcutaneous dihydroergotamine mesylate (DHE-45) vs subcutaneous sumatriptan succinate (Imitrex) for the treatment of acute migraine with or without aura.
Double-blind, randomized trial with parallel treatment arms.
Clinics and private neurology practices.
Patients of either sex, with migraine with or without aura, between the ages of 18 and 65 years.
Patients with moderate or severe head pain were randomized to receive either 1 mg of subcutaneous dihydroergotamine mesylate or 6 mg of subcutaneous sumatriptan succinate. Patients rated head pain, functional ability, nausea, and vomiting at baseline and at 0.5, 1, 2, 4, and 24 hours after the injection. Presence or absence of headache at 3 hours was calculated from collected data. If pain persisted after 2 hours, a second injection of the same study medication was allowed, and self-ratings were repeated 30 and 60 minutes later. Follow-up data were collected at 24 hours.
Relief of head pain and recurrence of successfully treated headache.
There were 295 evaluable patients. At 2 hours, 73.1% of the patients treated with dihydroergotamine and 85.3% of those treated with sumatriptan had relief (P = .002). There was no statistical difference in headache relief between the groups at 3 or 4 hours. Headache relief was achieved by 85.5% of those treated with dihydroergotamine and by 83.3% of those treated with sumatriptan by 4 hours. By 24 hours 89.7% of dihydroergotamine-treated patients and 76.7% of sumatriptan-treated patients had relief (P = .004). Headache recurred within 24 hours after treatment in 45% of the sumatriptan-treated patients and in 17.7% of the dihydroergotamine-treated patients (P < or = .001).
Both sumatriptan and dihydroergotamine were effective in aborting migraine headaches. Headache recurrence was two and a half time as likely with sumatriptan as with dihydroergotamine.
评估皮下注射甲磺酸二氢麦角胺（DHE - 45）与皮下注射琥珀酸舒马普坦（英明格）治疗伴或不伴先兆的急性偏头痛的疗效和耐受性。
采用平行治疗组的双盲随机试验。
诊所和私人神经科诊疗机构。
年龄在18至65岁之间、患伴或不伴先兆偏头痛的男女患者。
中重度头痛患者被随机分为两组，分别接受1毫克皮下注射甲磺酸二氢麦角胺或6毫克皮下注射琥珀酸舒马普坦。患者在基线时以及注射后0.5、1、2、4和24小时对头痛、功能能力、恶心和呕吐情况进行评分。根据收集的数据计算3小时时是否存在头痛。如果2小时后疼痛仍持续，允许再次注射相同的研究药物，并在30分钟和60分钟后重复自我评分。在24小时时收集随访数据。
头痛缓解情况和成功治疗后头痛的复发情况。
共有295例可评估患者。2小时时，接受二氢麦角胺治疗的患者中有73.1%头痛缓解，接受舒马普坦治疗的患者中有85.3%头痛缓解（P = 0.002）。两组在3小时或4小时时头痛缓解情况无统计学差异。4小时时，接受二氢麦角胺治疗的患者中有85.5%头痛缓解，接受舒马普坦治疗的患者中有83.3%头痛缓解。到24小时时，接受二氢麦角胺治疗的患者中有89.7%头痛缓解，接受舒马普坦治疗的患者中有76.7%头痛缓解（P = 0.004）。舒马普坦治疗组45%的患者在治疗后24小时内头痛复发，二氢麦角胺治疗组为17.7%（P≤0.001）。
舒马普坦和二氢麦角胺在终止偏头痛发作方面均有效。舒马普坦导致头痛复发的可能性是二氢麦角胺的2.5倍。
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