Bousser M G, Baron J C
Clinique des Maladies du Système Nerveux, Hôpital de la Salpêtrière, Paris, France.
Neuroepidemiology. 1987;6(4):228-33. doi: 10.1159/000110124.
The definition of efficacy parameters in drug trials of migraine has received little attention and the tendency has been to take into account many parameters, which leads to the possibility of some positive results being obtained purely by chance. In trials of prophylactic drug treatment, the major parameter is the frequency of attacks. Patients with frequent interval headache should preferably be excluded from such trials since there is no satisfactory way to distinguish interval headache from mild migraine attacks. Severity and duration of attacks are important parameters but they are difficult to interpret since they are modified by symptomatic medication. The mean score of each attack by consumption of symptomatic medication gives a good estimate of the severity and duration of attacks, but the problem of equalizing different medications in order to obtain a single estimate has not been solved. In trials of abortive drug treatment, there is at present no agreement upon the single most important parameter. Severity of headache, severity of associated symptoms, global efficacy and duration of attacks are all modified by escape medication. The need for escape medication is a better parameter but its power to discriminate ineffective and partially effective drugs is low. It is suggested that the major parameter could be the number of attacks aborted in 2 h or less, which is a simple quantitative and clinically relevant criterion.
偏头痛药物试验中疗效参数的定义很少受到关注，而且往往会考虑许多参数，这就导致一些阳性结果有可能纯粹是偶然获得的。在预防性药物治疗试验中，主要参数是发作频率。频繁发作间歇性头痛的患者最好排除在这类试验之外，因为目前尚无令人满意的方法来区分间歇性头痛和轻度偏头痛发作。发作的严重程度和持续时间是重要参数，但由于会受到对症药物的影响，所以难以解释。通过使用对症药物得出的每次发作的平均评分能较好地估计发作的严重程度和持续时间，但为了获得单一估计值而使不同药物等效的问题尚未解决。在急性发作药物治疗试验中，目前对于单一最重要的参数尚无共识。头痛的严重程度、相关症状的严重程度、总体疗效和发作持续时间都会受到解救药物的影响。使用解救药物的必要性是一个更好的参数，但其区分无效药物和部分有效药物的能力较低。有人建议主要参数可以是在2小时或更短时间内终止发作的次数，这是一个简单的定量且与临床相关的标准。
