Dahlöf C, Björkman R
Gothenburg Migraine Clinic, Sociala Huset, Gothenburg, Sweden.
Cephalalgia. 1993 Apr;13(2):117-23. doi: 10.1046/j.1468-2982.1993.1302117.x.
The aim of the present study was to assess the efficacy and tolerability of single oral doses of 50 mg and 100 mg of diclofenac-K compared to placebo in migraine sufferers during three attacks. The study was conducted in a double-blind, randomized, placebo-controlled, three-period, within-patient comparative trial; 72 migraine patients were treated with diclofenac-K (50 mg or 100 mg) or placebo at six centres (1 in Sweden and 5 in Finland). The primary efficacy end-point was the change in pain intensity assessed on a 100 mm Visual Analogue Scale (VAS) at 120 min after taking the study medication. We found that 50 mg and 100 mg of diclofenac-K reduced the pain intensity significantly better than placebo (p = 0.003 and p = 0.001, respectively), without difference between the doses; 100 mg diclofenac-K was significantly better than placebo in improving phonophobia, photophobia, working ability and need for rescue medication. Diclofenac-K 50 mg or 100 mg is an effective and well-tolerated acute treatment for migraine headache and its associated symptoms. The higher dose of diclofenac-K was only marginally more effective than the lower dose.
本研究的目的是评估在偏头痛患者经历三次发作期间，单次口服50毫克和100毫克双氯芬酸钾与安慰剂相比的疗效和耐受性。该研究采用双盲、随机、安慰剂对照、三阶段、患者自身对照的比较试验；72名偏头痛患者在六个中心（瑞典1个，芬兰5个）接受双氯芬酸钾（50毫克或100毫克）或安慰剂治疗。主要疗效终点是服用研究药物120分钟后，通过100毫米视觉模拟量表（VAS）评估的疼痛强度变化。我们发现，50毫克和100毫克双氯芬酸钾降低疼痛强度的效果显著优于安慰剂（分别为p = 0.003和p = 0.001），且两种剂量之间无差异；100毫克双氯芬酸钾在改善畏声、畏光、工作能力和急救药物需求方面显著优于安慰剂。50毫克或100毫克双氯芬酸钾是治疗偏头痛及其相关症状的有效且耐受性良好的急性药物。双氯芬酸钾的高剂量仅比低剂量略微有效。
