Stöckli H R, Sword A
Neurologische Praxis, Liestal.
Praxis (Bern 1994). 2003 Feb 26;92(9):379-89. doi: 10.1024/0369-8394.92.9.379.
In an open, prospective study in 27 Swiss neurological practices and polyclinics, the fastmelt formulation of zolmitriptan was tested in 113 migraine patients as a therapeutic agent for migraine attacks (ZORO [= Zomig oro] Studie). A total of 311 attacks with and without aura were analyzed. With the help of a structured diary, the patients documented each attack in detail by recording the time of onset of the migraine, the intensity, when the medication was taken, the duration of the migraine, concomitant symptoms, concurrent medication and adverse effects. The subjective onset of effect was reached within 60 minutes in 56% of the cases, and within two hours in 73%. The pain intensity was determine with a visual analog pain scale from 1 to 10. The effect, defined by a decline in pain of two or more levels, was achieved within two hours in 68% of the attacks (ITT population). An average of 34% of the ITT patients achieved complete freedom from pain within 120 minutes. The meaningful migraine relief (MMR), defined as a marked improvement in well-being, was achieved within 120 minutes in 59% of all attacks, and after > 2 hours another 34% achieved this state. A decline of approximately 50% in intensity of the concomitant symptoms of nausea, photophobia and phonophobia within two hours was measured on a 10-point visual analog scale (0 = no symptoms; 10 = extremely severe symptoms). After the initial therapeutic effect, migraine recurrences occurred within 4-24 hours after intake of medication in 22% of the cases on the average. The known adverse effects caused by triptan were reported by 17% of the patients. Most of them did not lead to termination of treatment, and none of the more severe adverse effects were reported. In the patient diary, the study participants were also asked about the time of onset of the migraine and the time of taking the medication, in the assumption that this interval would be relatively short from the standpoint of ideal fabrication of the preparation. Surprisingly, despite the fact that patients were instructed by the study neurologists to take the medication as promptly as possible at the onset of an attack, the patients waited a median of 90 minutes after the onset of the migraine (n = 308 attacks) before taking the triptan. In the visual 10-point scale, this time increased the average pain intensity from a median of 5.0 to 6.0. There are various reasons that may explain this unexpected behavior (the experience of many migraine patients that attacks often subside spontaneously within a short period of time; the difficulty of distinguishing an incipient migraine from a tension headache, etc.). Further research will be necessary to clarify this situation. With regard to efficacy in headaches, concomitant autonomic symptoms, rapid onset of effect, and acceptance, this fastmelt triptan formulation represents real competition with the other triptans in the usual tablet formulation. It is especially suitable for active migraine patients who would like to have an effective therapeutic agent available for rapid use in all life situations.
在瑞士27家神经科诊所和综合门诊部进行的一项开放性前瞻性研究中，对113例偏头痛患者测试了佐米曲普坦速溶制剂作为偏头痛发作的治疗药物（ZORO[=佐米格口服速溶片]研究）。共分析了311次有先兆和无先兆的发作。借助结构化日记，患者通过记录偏头痛发作时间、强度、服药时间、偏头痛持续时间、伴随症状、同时服用的药物及不良反应，详细记录每次发作情况。56%的病例在60分钟内达到主观起效，73%在两小时内起效。用1至10的视觉模拟疼痛量表确定疼痛强度。在两小时内，68%的发作（意向性分析人群）疼痛程度下降两个或更多级别，即达到治疗效果。平均34%的意向性分析患者在120分钟内实现完全无痛。59%的发作在120分钟内实现有意义的偏头痛缓解（MMR，定义为幸福感显著改善），两小时后另有34%达到此状态。在10分视觉模拟量表上（0=无症状；10=症状极其严重），两小时内恶心、畏光和畏声等伴随症状强度平均下降约50%。初始治疗效果后，平均22%的病例在服药后4至24小时内偏头痛复发。17%的患者报告了曲坦类药物已知的不良反应。大多数不良反应未导致治疗终止，未报告更严重的不良反应。在患者日记中，研究参与者还被问及偏头痛发作时间和服药时间，假定从理想制剂制备角度看，这个间隔会相对较短。令人惊讶的是，尽管研究神经科医生指示患者在发作开始时尽快服药，但患者在偏头痛发作后（n=308次发作）平均等待90分钟才服用曲坦类药物。在10分视觉量表上，这段时间使平均疼痛强度从中位数5.0增加到6.0。有多种原因可解释这种意外行为（许多偏头痛患者的经验是发作常短时间内自行缓解；难以区分初期偏头痛和紧张性头痛等）。需要进一步研究来阐明这种情况。就头痛疗效、伴随的自主神经症状、起效迅速及耐受性而言，这种速溶曲坦制剂与其他普通片剂剂型的曲坦类药物形成了真正竞争。它特别适合希望在所有生活场景中都能快速获得有效治疗药物的活动性偏头痛患者。
