Massiou H, Serrurier D, Lasserre O, Bousser M G
Department of Neurology, Hôpital Saint-Antoine, Paris, FRance.
Cephalalgia. 1991 May;11(2):59-63. doi: 10.1046/j.1468-2982.1991.1102059.x.
In a multicentre double-blind cross-over trial, oral diclofenac at a dose of 50 mg to 100 mg was compared to placebo in the acute treatment of migraine attacks. A hundred and seven patients suffering from migraine without aura were included, and 91 were analysed for efficacy; they had to treat four successive attacks--two with diclofenac and two with placebo. Diclofenac was significantly more effective than placebo (p less than 0.05) on the main judgement parameter, which was the number of attacks aborted within 2 h of drug intake, as well as on the following secondary parameters: the necessity for an escape medication and the evaluation of global efficacy. Diclofenac was well tolerated. This trial demonstrates the efficacy of diclofenac in the acute treatment of migraine attacks. It confirms the good clinical relevance of the main judgement parameter chosen, which is the one recommended by the International Headache Society, but appears to be a severe one in terms of successes.
在一项多中心双盲交叉试验中，将剂量为50毫克至100毫克的口服双氯芬酸与安慰剂用于偏头痛发作的急性治疗并进行比较。纳入了107例无先兆偏头痛患者，其中91例进行了疗效分析；他们必须连续治疗4次发作——2次使用双氯芬酸，2次使用安慰剂。在主要判断参数（即服药后2小时内中止发作的次数）以及以下次要参数方面，双氯芬酸比安慰剂显著更有效（p<0.05）：使用解救药物的必要性和总体疗效评估。双氯芬酸耐受性良好。该试验证明了双氯芬酸在偏头痛发作急性治疗中的疗效。它证实了所选择的主要判断参数具有良好的临床相关性，该参数是国际头痛协会推荐的，但就成功而言似乎较为严格。
