Gruffyd-Jones K, Kies B, Middleton A, Mulder L J, Røsjø Ø, Millson D S
Box Surgery, London Road, Box Corsham, Wiltshire, UK.
Eur J Neurol. 2001 May;8(3):237-45. doi: 10.1046/j.1468-1331.2001.00218.x.
This randomized, double-blind, parallel-group study compared the efficacy and tolerability of zolmitriptan (2.5 or 5 mg) and sumatriptan (50 mg) in the acute oral treatment of up to six moderate-to-severe migraine attacks. The intention to treat (ITT) population comprised of 1522 patients: 500 treated with zolmitriptan 2.5 mg (2671 attacks), 514 with zolmitriptan 5 mg (2744 attacks) and 508 with sumatriptan 50 mg (2693 attacks). Overall, the 2-h headache response rates in these groups were 62.9, 65.7 and 66.6%, respectively. There were no statistically significant differences between sumatriptan 50 mg and zolmitriptan 2.5 mg (P = 0.12) or 5 mg (P = 0.80). Approximately 40% of patients in each group reported a 2-h headache response in > or = 80% of attacks. There were no statistically significant differences between the groups in the rates of headache response at 1 h (zolmitriptan 2.5 mg 36.9%, zolmitriptan 5 mg 39.5% and sumatriptan 50 mg 38.0%) or 4 h (70.3, 72.9 and 72.2%, respectively) or in the rates of meaningful migraine relief at 1, 2 or 4 h or sustained (24-h) pain relief. All treatments were well tolerated. In conclusion, zolmitriptan (2.5 or 5 mg) proved similarly efficacious compared with sumatriptan (50 mg), both in terms of response rates and consistency across attacks.
这项随机、双盲、平行组研究比较了佐米曲普坦（2.5毫克或5毫克）和舒马曲坦（50毫克）在急性口服治疗多达6次中度至重度偏头痛发作中的疗效和耐受性。意向性治疗（ITT）人群包括1522名患者：500名接受2.5毫克佐米曲普坦治疗（2671次发作），514名接受5毫克佐米曲普坦治疗（2744次发作），508名接受50毫克舒马曲坦治疗（2693次发作）。总体而言，这些组中2小时头痛缓解率分别为62.9%、65.7%和66.6%。50毫克舒马曲坦与2.5毫克佐米曲普坦（P = 0.12）或5毫克佐米曲普坦（P = 0.80）之间无统计学显著差异。每组中约40%的患者报告在≥80%的发作中出现2小时头痛缓解。各组在1小时（2.5毫克佐米曲普坦36.9%、5毫克佐米曲普坦39.5%和50毫克舒马曲坦38.0%）或4小时（分别为70.3%、72.9%和72.2%）的头痛缓解率，或在1、2或4小时有意义的偏头痛缓解率或持续（24小时）疼痛缓解率方面无统计学显著差异。所有治疗耐受性良好。总之，就缓解率和各次发作的一致性而言，佐米曲普坦（2.5毫克或5毫克）与舒马曲坦（50毫克）相比疗效相似。
