Henry P, d'Allens H
Service de Neurologie, Hopital Pellegrin Tripode, Bordeaux, Paris, France.
Headache. 1993 Sep;33(8):432-5. doi: 10.1111/j.1526-4610.1993.hed3308432.x.
The efficacy of sumatriptan, a 5-HT1 receptor agonist, in patients with migraine attacks occurring despite prophylactic treatment with oral dihydroergotamine, was assessed in a double-blind placebo-controlled study involving 76 patients. Thirty-seven patients were treated with a subcutaneous injection of 6 mg sumatriptan self-administered with an auto-injector and 39 with placebo given by the same route. Patients having inadequate relief were allowed to use a second injection of test medication 1 hour later and rescue treatment between 2 hours and 24 hours after the first dose. Headache relief was achieved within 2 hours after sumatriptan in 26 patients (70%) compared to 8 patients (21%) in the placebo group (P < 0.0001). Of these patients, 19 (51%) and 3 (8%) were, respectively, pain free at this time. A second injection of sumatriptan was used by 8 (22%) patients compared to 30 (77%) patients in the placebo group (P < 0.0001), whereas rescue medication was used respectively by 13 (35%) and 22 (58%) patients (P < 0.024). The adverse event profile of sumatriptan was not affected by the concomitant use of dihydroergotamine and side-effects were all minor and transient. Patient satisfaction was significantly higher in the sumatriptan group (75%) compared to patient satisfaction with placebo (16%). These results show that the high efficacy rate of subcutaneous sumatriptan and its safety profile remain unchanged in migraine patients receiving oral dihydroergotamine as prophylaxis.
在一项涉及76例患者的双盲安慰剂对照研究中,评估了5-羟色胺1(5-HT1)受体激动剂舒马曲坦对尽管接受口服二氢麦角胺预防性治疗仍发生偏头痛发作患者的疗效。37例患者皮下注射6毫克舒马曲坦,由自动注射器自行给药,39例患者接受相同途径给予的安慰剂。缓解不充分的患者可在1小时后使用第二次试验药物注射,并在首剂后2小时至24小时进行急救治疗。舒马曲坦组26例患者(70%)在2小时内头痛缓解,而安慰剂组为8例患者(21%)(P<0.0001)。其中,此时分别有19例(51%)和3例(8%)患者疼痛消失。8例(22%)患者使用了第二次舒马曲坦注射,而安慰剂组为30例(77%)患者(P<0.0001),而分别有13例(35%)和22例(58%)患者使用了急救药物(P<0.024)。舒马曲坦的不良事件情况不受同时使用二氢麦角胺的影响,且副作用均轻微且短暂。舒马曲坦组患者满意度(75%)显著高于安慰剂组患者满意度(1 . 6%)。这些结果表明,皮下注射舒马曲坦的高有效率及其安全性在接受口服二氢麦角胺预防性治疗的偏头痛患者中保持不变。