鼻内注射佐米曲普坦治疗急性丛集性头痛的有效性：一项随机、安慰剂对照、双盲交叉研究。

Effectiveness of intranasal zolmitriptan in acute cluster headache: a randomized, placebo-controlled, double-blind crossover study.

作者信息

Cittadini Elizabeth, May Arne, Straube Andreas, Evers Stefan, Bussone Gennaro, Goadsby Peter J

机构信息

Institute of Neurology, The National Hospital for Neurology and Neurosurgery, Queen Square, London, England.

出版信息

Arch Neurol. 2006 Nov;63(11):1537-42. doi: 10.1001/archneur.63.11.nct60002. Epub 2006 Sep 11.

DOI:10.1001/archneur.63.11.nct60002

PMID:16966497

Abstract

BACKGROUND

Cluster headache is a form of primary headache in which attacks are rapid in onset with very severe pain. The mainstays of acute therapy are inhaled oxygen and sumatriptan succinate injection.

OBJECTIVE

To evaluate zolmitriptan nasal spray in the acute treatment of cluster headache.

METHODS

Ninety-two patients, aged 40 +/- 10 years (mean +/- SD) (80 men and 12 women), with International Headache Society-defined cluster headache were randomized into a placebo-controlled, double-blind crossover study. Patients treated 3 headache attacks using placebo for 1 attack, 5 mg of zolmitriptan nasal spray (ZNS5) for 1 attack, and 10 mg of zolmitriptan nasal spray for 1 attack. The primary end point was headache relief at 30 minutes, defined as reduction from moderate, severe, or very severe pain to no or mild pain. The study was approved by the appropriate ethics committees.

RESULTS

Sixty-nine patients were available for an intention-to-treat analysis. The 30-minute headache relief rates were placebo, 21%; ZNS5, 40%; and ZNS10, 62%. Modeling the response as a binary outcome, the Wald test was significant for the overall regression (chi(2)(1) = 29.4; P<.001), with both ZNS5 and ZNS10 giving significant effects against placebo. Headache relief rates for patients with episodic cluster headache were 30% for placebo, 47% for ZNS5, and 80% for ZNS10, while corresponding rates for patients with chronic cluster headache were 14%, 28%, and 36%, respectively. Zolmitriptan was also well tolerated.

CONCLUSION

Five-milligram and 10-mg doses of zolmitriptan intranasal spray are effective within 30 minutes and well tolerated in the treatment of acute cluster headache. Trial Registration controlled-trials.com Identifier ISCRTN27362692.

摘要

背景

丛集性头痛是原发性头痛的一种形式，发作迅速且疼痛极为剧烈。急性治疗的主要方法是吸入氧气和注射舒马曲坦琥珀酸盐。

目的

评估佐米曲普坦鼻喷雾剂在丛集性头痛急性治疗中的效果。

方法

92例年龄为40±10岁（平均±标准差）（80例男性和12例女性）、符合国际头痛协会定义的丛集性头痛患者被随机纳入一项安慰剂对照、双盲交叉研究。患者用安慰剂治疗3次头痛发作中的1次，用5毫克佐米曲普坦鼻喷雾剂（ZNS5）治疗1次，用10毫克佐米曲普坦鼻喷雾剂治疗1次。主要终点是30分钟时头痛缓解，定义为从中度、重度或极重度疼痛减轻至无疼痛或轻度疼痛。该研究得到了适当伦理委员会的批准。

结果

69例患者可进行意向性分析。30分钟时的头痛缓解率分别为：安慰剂组21%；ZNS5组40%；ZNS10组62%。将反应建模为二元结果，总体回归的Wald检验具有显著性（χ(2)(1)=29.4；P<0.001），ZNS5和ZNS10对安慰剂均有显著效果。发作性丛集性头痛患者的头痛缓解率分别为：安慰剂组30%，ZNS5组47%，ZNS10组80%；而慢性丛集性头痛患者的相应缓解率分别为14%、28%和36%。佐米曲普坦的耐受性也良好。