Kjaersgård Rasmussen M J, Holt Larsen B, Borg L, Soelberg Sørensen P, Hansen P E
Department of Neurology, Soenderborg Sygehus, Copenhagen, Denmark.
Acta Neurol Scand. 1994 Jun;89(6):446-50. doi: 10.1111/j.1600-0404.1994.tb02664.x.
The prophylactic effect of tolfenamic acid and propranolol was studied in a randomized double-blind cross-over trial of 76 patients with migraine with or without aura. After a 4-week run-in period patients were randomly allocated to treatment with either tolfenamic acid 100 mg three times daily or propranolol 40 mg three times daily for 12 weeks. After a placebo wash-out period of 4 weeks the patients got the alternative drug for 12 weeks; 56 patients completed the study. Both drugs significantly reduced migraine attacks as judged from the reduction in the efficacy parameters (migraine hours, migraine days, and migraine intensity) in the treatment periods compared with the run-in period. No statistical significant difference in any efficacy parameter was found between the two drugs (level 2 alpha = 0.05, alpha = 0.10). The adverse effects showed no statistical difference in frequency between the 2 treatments. Twenty patients discontinued the study: 12 patients on propranolol and 8 patients on tolfenamic acid. Side effects were the cause of premature discontinuation of study medicine in 9 patients during propranolol treatment (dizziness, fatigue, and fall in blood pressure) and in 5 patients during tolfenamic acid treatment (gastrointestinal symptoms).
在一项针对76例有或无先兆偏头痛患者的随机双盲交叉试验中，研究了托芬那酸和普萘洛尔的预防作用。经过4周的导入期后，患者被随机分配接受为期12周的治疗，每日三次服用100毫克托芬那酸或每日三次服用40毫克普萘洛尔。在经过4周的安慰剂洗脱期后，患者改用另一种药物治疗12周；56例患者完成了研究。与导入期相比，根据治疗期疗效参数（偏头痛小时数、偏头痛天数和偏头痛强度）的降低情况判断，两种药物均能显著减少偏头痛发作。两种药物在任何疗效参数上均未发现统计学显著差异（二级α = 0.05，α = 0.10）。两种治疗方法的不良反应发生频率无统计学差异。20例患者退出研究：12例服用普萘洛尔，8例服用托芬那酸。副作用是导致9例患者在普萘洛尔治疗期间（头晕、疲劳和血压下降）以及5例患者在托芬那酸治疗期间（胃肠道症状）提前停用研究药物的原因。
