Cull R E, Price W H, Dunbar A
Department of Clinical Neurosciences, Western General Hospital, Edinburgh, UK.
J Neurol Neurosurg Psychiatry. 1997 May;62(5):490-5. doi: 10.1136/jnnp.62.5.490.
To investigate the efficacy of a second subcutaneous dose of 6 mg sumatriptan in the treatment of recurrence of headache after successful treatment of a migraine attack with an initial 6 mg dose.
In a prospective, randomised, placebo controlled, double blind, parallel group study, 803 patients were treated for one to three migraine attacks with severe or moderate headache with a subcutaneous injection of 6 mg sumatriptan. Any subsequent recurrence of migraine headache was treated with a randomised second injection of sumatriptan or placebo. Recurrence was defined as a headache of moderate or severe intensity occurring 1-24 hours after the initial dose in a patient whose headache had been relieved by sumatriptan (reduction of headache severity from severe or moderate to mild or none after one hour).
Headache recurrence was reported by 10%-15% of patients. At each attack, 6 mg sumatriptan given subcutaneously was significantly (P < 0.0005) more effective than placebo at relieving recurrent headache after one hour (84%-93% v 31%-50% of patients); 76%-83% of patients reported headache relief one hour after the initial dose of sumatriptan. Sumatriptan was generally well tolerated.
Up to 15% of patients with migraine experience significant recurrence of headache after successful treatment with subcutaneous sumatriptan, and this recurrence is effectively treated by a further dose of subcutaneous sumatriptan.
研究第二次皮下注射6毫克舒马曲坦治疗偏头痛发作初始剂量6毫克成功治疗后头痛复发的疗效。
在一项前瞻性、随机、安慰剂对照、双盲、平行组研究中,803例患者接受皮下注射6毫克舒马曲坦治疗一至三次伴有中重度头痛的偏头痛发作。偏头痛头痛的任何后续复发均采用随机二次注射舒马曲坦或安慰剂治疗。复发定义为初始剂量后1 - 24小时出现中重度头痛,且头痛已被舒马曲坦缓解的患者(头痛严重程度在一小时后从重度或中度降至轻度或无)。
10% - 15%的患者报告有头痛复发。在每次发作时,皮下注射6毫克舒马曲坦在一小时后缓解复发性头痛方面显著(P < 0.0005)优于安慰剂(84% - 93%对31% - 50%的患者);76% - 83%的患者在初始剂量舒马曲坦一小时后报告头痛缓解。舒马曲坦总体耐受性良好。
高达15%的偏头痛患者在皮下注射舒马曲坦成功治疗后会出现明显的头痛复发,进一步皮下注射舒马曲坦可有效治疗这种复发。