Kramer M S, Matzura-Wolfe D, Polis A, Getson A, Amaraneni P G, Solbach M P, McHugh W, Feighner J, Silberstein S, Reines S A
Merck Research Laboratories, West Point, PA, USA.
Neurology. 1998 Sep;51(3):773-81. doi: 10.1212/wnl.51.3.773.
To examine the safety and efficacy of rizatriptan 10 mg PO in the treatment of multiple migraine attacks.
Rizatriptan is a potent and rapidly absorbed 5-HT1B/1D receptor agonist. Efficacy and general safety have been examined in controlled trials treating single migraine attacks. In the current placebo-controlled study, we report constancy of safety and efficacy of rizatriptan for patients treating four discrete migraine attacks.
Patients with moderate or severe migraine (n = 473) were randomized to one of five sequence groups, in which each patient was to treat four migraine attacks. Patients in four groups received rizatriptan 10 mg for three of four attacks and placebo for the remaining attack. Patients in the fifth group received rizatriptan 10 mg for four attacks. Headache severity, functional disability, and migraine symptoms were measured immediately before dosing and at 0.5, 1, 1.5, 2, 3, and 4 hours postdose.
After the first attack, response rates were 77% for rizatriptan and 37% for placebo (p < 0.001). Similar efficacy of rizatriptan, ranging from a 75 to 80% response, was observed in each of the subsequent attacks with no evidence of tolerance to therapeutic effects. Most patients (93%) responded to rizatriptan 10 mg during the first or second attack. Adverse experiences were generally mild and transient, the most common being dizziness and somnolence. Incidence of adverse experiences per attack decreased after the first attack.
Rizatriptan 10 mg PO is efficacious and generally well tolerated in acute migraine. Its efficacy is maintained throughout the treatment of multiple, discrete migraine attacks.
研究口服10毫克利扎曲普坦治疗多次偏头痛发作的安全性和有效性。
利扎曲普坦是一种强效且吸收迅速的5-HT1B/1D受体激动剂。在治疗单次偏头痛发作的对照试验中已对其有效性和总体安全性进行了研究。在当前这项安慰剂对照研究中，我们报告了利扎曲普坦治疗四次独立偏头痛发作患者的安全性和有效性的一致性。
中度或重度偏头痛患者（n = 473）被随机分为五个序列组之一，每组患者要治疗四次偏头痛发作。四组患者在四次发作中的三次服用10毫克利扎曲普坦，其余一次服用安慰剂。第五组患者四次发作均服用10毫克利扎曲普坦。在给药前以及给药后0.5、1、1.5、2、3和4小时测量头痛严重程度、功能障碍和偏头痛症状。
首次发作后，利扎曲普坦的缓解率为77%，安慰剂为37%（p < 0.001）。在随后的每次发作中均观察到利扎曲普坦有相似的疗效，缓解率在75%至80%之间，且没有对治疗效果产生耐受性的证据。大多数患者（93%）在首次或第二次发作时对10毫克利扎曲普坦有反应。不良事件一般较轻且为短暂性，最常见的是头晕和嗜睡。首次发作后每次发作的不良事件发生率有所下降。
口服10毫克利扎曲普坦治疗急性偏头痛有效且耐受性一般良好。在多次独立偏头痛发作的整个治疗过程中其疗效得以维持。
