Solomon S
Headache Unit, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.
Neuroepidemiology. 1987;6(4):164-71. doi: 10.1159/000110115.
General concepts and specific factors to be used in the selection of patients for clinical drug trials in migraine are discussed. The definition of common migraine has been unsatisfactory and new diagnostic operational criteria are recommended. Patients with headaches that are a mixture of tension headache and migraine, and migraineurs who have interval headaches which are not clearly differentiated from migraine should be excluded. The headaches should be of moderate to severe degree, in the range of 2-6 per month, and should last from 3 h to 3 days. It would be best for migraine to have been present for at least 1 year, with 3 months retrospective and 2 months prospective observation prior to drug trial. The age of onset of migraine should be below 50, and the age of entry into the study less than 60. Migraineurs in good health, of either sex, are to be included in the study. Occasional use of minor tranquilizers and sedatives as well as of contraceptive drugs is acceptable, but patients who abuse drugs, who are allergic to compounds related to the trial drug and who require major psychotropic medication should be excluded. Also excluded are those whose compliance with the drug trial is doubtful for intellectual or, more often, psychological reasons.
讨论了偏头痛临床药物试验患者选择中使用的一般概念和具体因素。普通偏头痛的定义一直不尽人意，因此推荐了新的诊断操作标准。应排除紧张性头痛和偏头痛混合性头痛患者，以及发作间期头痛与偏头痛难以明确区分的偏头痛患者。头痛应为中度至重度，每月发作2 - 6次，持续3小时至3天。偏头痛最好已存在至少1年，在药物试验前进行3个月的回顾性观察和2个月的前瞻性观察。偏头痛的发病年龄应低于50岁，进入研究的年龄应小于60岁。健康状况良好的男女偏头痛患者均应纳入研究。偶尔使用小剂量镇静剂和镇静催眠药以及避孕药是可以接受的，但滥用药物、对试验药物相关化合物过敏以及需要使用主要精神药物的患者应排除在外。对于因智力原因，更常见的是因心理原因而对药物试验依从性存疑的患者也应排除。
