Silberstein S D, Massiou H, Le Jeunne C, Johnson-Pratt L, McCarroll K A, Lines C R
Jefferson Headache Center, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, USA.
Obstet Gynecol. 2000 Aug;96(2):237-42. doi: 10.1016/s0029-7844(00)00880-2.
To determine the efficacy of oral rizatriptan 10 mg and 5 mg for treating menstrually associated migraine attacks.
Data from two large clinical trials with identical designs were included in a retrospective analysis. The studies were randomized, double-masked, placebo-controlled, incomplete block, two-period, crossover designs. Women with migraines were randomly assigned to one of five treatment sequences for the treatment of two migraine attacks. Only data from the first attack in women with migraines who were treated with rizatriptan or placebo were included in the analysis. A menstrually associated attack was defined as one that occurred within 3 days before or after the onset of the last menstrual period.
In the subgroup of 335 women with menstrually associated migraine, rizatriptan was effective compared with placebo. At 2 hours after dosing, 68% of 139 women taking rizatriptan 10 mg and 70% of 115 women taking rizatriptan 5 mg with a menstrually associated migraine had pain relief compared with 44% of 81 patients taking placebo (P <.05). In all women, rizatriptan was as effective in treating menstrual as well as nonmenstrual migraine: 68% of 139 patients taking rizatriptan 10 mg with a menstrually associated migraine had pain relief at 2 hours after dosing compared with 69% of 393 patients with nonmenstrually associated attacks (test of menstrual association = nonsignificant; the analysis had 80% power to detect a difference of six percentage points between groups). Similar results were found for rizatriptan 5 mg (menstrual = 70%, nonmenstrual = 66%; not statistically significant).
Rizatriptan is effective in the treatment of menstrually associated migraine attacks.
确定口服10毫克和5毫克利扎曲普坦治疗月经相关性偏头痛发作的疗效。
两项设计相同的大型临床试验数据纳入回顾性分析。这些研究采用随机、双盲、安慰剂对照、不完全区组、两阶段、交叉设计。偏头痛女性被随机分配到五个治疗序列之一,以治疗两次偏头痛发作。分析仅纳入接受利扎曲普坦或安慰剂治疗的偏头痛女性首次发作的数据。月经相关性发作定义为在上次月经开始前或后3天内发生的发作。
在335例月经相关性偏头痛女性亚组中,与安慰剂相比,利扎曲普坦有效。给药后2小时,139例服用10毫克利扎曲普坦且患有月经相关性偏头痛的女性中,68%疼痛缓解;115例服用5毫克利扎曲普坦且患有月经相关性偏头痛的女性中,70%疼痛缓解;相比之下,81例服用安慰剂的患者中,44%疼痛缓解(P<.05)。在所有女性中,利扎曲普坦治疗月经性偏头痛和非月经性偏头痛的效果相同:139例服用10毫克利扎曲普坦且患有月经相关性偏头痛的患者中,68%在给药后2小时疼痛缓解;相比之下,393例患有非月经相关性发作的患者中,69%疼痛缓解(月经相关性检验=无显著性差异;该分析有80%的把握度检测组间6个百分点的差异)。5毫克利扎曲普坦也有类似结果(月经性=70%,非月经性=66%;无统计学显著性差异)。
利扎曲普坦对治疗月经相关性偏头痛发作有效。