Headache. 1998 Mar;38(3):173-83.
This international open-label study evaluated the tolerability and efficacy of zolmitriptan (Zomig, 311C90), a selective 5-HT1B/1D receptor agonist, in the long-term treatment of multiple migraine attacks. Patients who had previously participated in placebo-controlled zolmitriptan studies were recruited. A total of 2058 patients treated 31,579 migraine attacks (average 15 per patient), for up to 1 year. Twenty-six percent of attacks treated with a single zolmitriptan 5-mg dose were associated with at least one adverse event (24% treated with two doses). The most frequent adverse events included asthenia (14% of patients), nausea (12%), somnolence (10%), dizziness (11%), and paresthesia (11%). The rank order of the most common adverse events was not influenced by sex, age, or number of zolmitriptan doses taken and was similar between attacks 1 and 45. The majority of adverse events (59%) occurred within 2 hours of dosing, were of either mild (59%) or moderate (35%) intensity, of 4 hours' duration or less (67%), and required no further action (94%). Following an initial 5-mg dose of zolmitriptan, the 2-hour headache response rate (reduction in headache pain from moderate or severe before treatment to mild or no pain at 2 hours posttreatment) was 81% in patients treating moderate and severe attacks (19,639 of 24,161). Patients were pain-free at 2 hours in 55% of all attacks (16,510 of 29,808). The efficacy of zolmitriptan was not influenced by age, sex, weight, use of prophylactic antimigraine medication, or association of attacks with menstruation. Analysis of the overall population and a subgroup who treated 30 or more migraine attacks showed that zolmitriptan was consistently effective across attacks. Overall, 67% of patients who treated five or more attacks reported zolmitriptan to be effective in 80% to 100% of attacks. Zolmitriptan produced meaningful migraine relief and improvement in normal activity impairment in 73% and 78% of moderate and severe attacks, respectively. Patients treated recurrence of moderate or severe headache with a second zolmitriptan dose in 32% of attacks which responded to the first dose within 2 hours. Where required, a second zolmitriptan 5-mg dose for treatment of recurrence produced a headache response rate of 90% at 2 hours postdose. Thus, zolmitriptan 5 mg (plus an optional second 5-mg dose for treatment of recurrence) is well tolerated and effective in the acute treatment of multiple migraine attacks over periods up to 1 year.
这项国际开放性研究评估了选择性5-羟色胺1B/1D受体激动剂佐米曲普坦（佐米格，311C90）在长期治疗多次偏头痛发作中的耐受性和疗效。招募了之前参与过佐米曲普坦安慰剂对照研究的患者。共有2058名患者接受了31579次偏头痛发作的治疗（平均每位患者15次），治疗时间长达1年。单次服用5毫克佐米曲普坦治疗的发作中，26%至少伴有一项不良事件（两次给药治疗的为24%）。最常见的不良事件包括乏力（14%的患者）、恶心（12%）、嗜睡（10%）、头晕（11%）和感觉异常（11%）。最常见不良事件的排序不受性别、年龄或服用佐米曲普坦剂量数的影响，在第1次和第45次发作之间相似。大多数不良事件（59%）在给药后2小时内出现，强度为轻度（59%）或中度（35%），持续时间为4小时或更短（67%），且无需进一步处理（94%）。在初始服用5毫克佐米曲普坦后，治疗中度和重度发作的患者中，2小时头痛缓解率（头痛疼痛从治疗前的中度或重度降至治疗后2小时的轻度或无痛）为81%（24161次发作中的19639次）。在所有发作中，55%的患者在2小时时无痛（29808次发作中的16510次）。佐米曲普坦的疗效不受年龄、性别、体重、预防性抗偏头痛药物的使用或发作与月经的相关性影响。对总体人群以及治疗30次或更多偏头痛发作的亚组分析表明，佐米曲普坦在各次发作中均持续有效。总体而言，治疗5次或更多发作的患者中，67%报告佐米曲普坦在80%至100%的发作中有效。佐米曲普坦分别使73%和78%的中度和重度发作的偏头痛得到有意义的缓解，并改善了正常活动障碍。在2小时内对首次剂量有反应的发作中，32%的患者用第二次佐米曲普坦剂量治疗中度或重度头痛复发。在需要时，用于治疗复发的第二次5毫克佐米曲普坦剂量在给药后2小时的头痛缓解率为90%。因此，5毫克佐米曲普坦（加上用于治疗复发的可选的第二次5毫克剂量）耐受性良好，在长达1年的时间内对多次偏头痛发作的急性治疗有效。
