Treves T A, Kuritzky A, Hering R, Korczyn A D
Tel Aviv Souraski Medical Center, Petach Tikva, Israel.
Headache. 1998 Sep;38(8):614-7. doi: 10.1046/j.1526-4610.1998.3808614.x.
To evaluate the efficacy and safety of dihydroergotamine (DHE) nasal spray in patients suffering from common or classical migraine.
In a double-blind parallel-group study, 52 outpatients with migraine were randomly allocated to DHE nasal spray or to placebo. Two puffs, one in each nostril, was taken as an initial dose (resulting in either 0.5 or 1 mg of DHE), followed by another puff (0.5 mg) after 30 and 60 minutes, if necessary, achieving a maximum dose of 2 mg for patients of the DHE 1-mg group or of 1.5 mg for patients of the 0.5-mg group. Four consecutive attacks were thus treated. The efficacy analysis was done for observed cases. The main outcome measure was reduction of the severity of the attacks.
No differences were observed in the migraine characteristics or the number of treatments of the patients from the different groups. Dihydroergotamine 1 mg tended to provide better relief than 0.5 mg, although the effect was not statistically significant. Patients taking DHE used less rescue medications, with a dose-dependent effect. Side effects were reported by four patients receiving DHE but not placebo. The tolerability of the drug was assessed as good by 94% of the patients.
These findings suggest that DHE nasal spray is well tolerated and has dose-dependent efficacy in migraine.
评估双氢麦角胺（DHE）鼻喷雾剂对普通型或典型偏头痛患者的疗效和安全性。
在一项双盲平行组研究中，52例偏头痛门诊患者被随机分配至DHE鼻喷雾剂组或安慰剂组。初始剂量为每侧鼻孔喷两下（相当于0.5或1毫克DHE），必要时在30分钟和60分钟后再各喷一下（0.5毫克），DHE 1毫克组患者最大剂量为2毫克，0.5毫克组患者最大剂量为1.5毫克。如此连续治疗4次发作。对观察病例进行疗效分析。主要观察指标为发作严重程度的减轻情况。
不同组患者的偏头痛特征或治疗次数未观察到差异。1毫克双氢麦角胺的缓解效果倾向于优于0.5毫克，尽管差异无统计学意义。服用DHE的患者使用的急救药物较少，呈剂量依赖性效应。4例接受DHE治疗的患者报告了副作用，而接受安慰剂治疗的患者未报告。94%的患者对该药物耐受性的评估为良好。
这些发现表明，DHE鼻喷雾剂耐受性良好，对偏头痛具有剂量依赖性疗效。
