Lancet neurology: 泼尼松在短期预防发作性丛集性头痛的安全性和有效性

2020-12-31 MedSci原创 MedSci原创

导语:口服泼尼松是一种有效的短期预防CH发作方法。泼尼松的长期预防疗效仍需进一步研究。

丛集性头痛(cluster headache, CH)属于血管性头痛之一。特点是在是一段时间内密集发作,因此是所有头痛中较为严重的一种。CH多见于青年人,20~40岁,男性发病率为女性的4~5倍,一般无家族史。

 

不同于偏头痛,CH发作前无先兆,头痛固定于一侧眼及眼眶周围。发作多在晚间,初感一侧眼及眼眶周围胀感或压迫感,数分钟后迅速发展为剧烈胀痛或钻痛,并向同侧额颞部和顶枕部扩散,同时伴有疼痛侧球结膜充血、流泪、流涕、出汗、眼睑轻度水肿,少有呕吐。

 

部分患者头痛发作时十分痛苦,坐卧不宁,一般持续15~180分钟,此后症状迅速消失,缓解后仍可从事原有活动。呈丛集性发作时,即每天发作1次至数次,每天大约在相同时间发作,有的像定时钟一样,几乎在恒定的时间发作,每次发作症状和持续时间几乎相同。

 

预防性药物维拉帕米等生效之前,泼尼松通常用于偶发性CH的初始短期治疗。但目前尚无大型随机试验对其有效性进行验证。为此,来自德国Essen大学附属医院神经内科的专家团队对泼尼松治疗CH的疗效开展了一项多中心随机双盲试验,相关结果发表在Lancet neurology杂志上。

该研究从10个德国专业头痛中心招纳18-65岁之间、头痛发作不超过30天的CH患者。所有患者进行口服维拉帕米长期预防,然后使用交互网络进行1:1随机分为强的松组(100mg口服5天,每3天逐渐减量20mg)与安慰剂组。

 

研究的主要终点是与安慰剂组相比,泼尼松治疗第一周头痛发作次数。其中发作的定义为数字评分量表高于5分。疗效和安全性分析使用治疗意向分析法(mITT)进行评估。

 

2013.04.05-2018.01.11期间,共116名患者进行随机分组(泼尼松组57人,安慰剂组59人),109名患者纳入mITT分析。泼尼松组与对照组第一周的平均发作次数分别为7.1 VS 9.5次(差异-2.4次,95% CI=-4.8--0.03,p=0.002)。研究中共发生2起严重不良事件(腹股沟疝和CH严重恶化),均发生在安慰剂组。此外,不良事件还包括头痛、心悸、头晕和恶心等,共发生270件,其中泼尼松组37名患者(71%)共报告135件,而安慰剂组55名患者(71%)也报告了135件。

两组患者每日发生头痛的次数。

 

由此可见,口服泼尼松是一种有效的短期预防CH发作方法。泼尼松的长期预防疗效仍需进一步研究。

 

参考文献:

 

Obermann M, Nägel S, Ose C, et al. Safety and efficacy of prednisone versus placebo in short-term prevention of episodic cluster headache: a multicentre, double-blind, randomised controlled trial. Lancet Neurol. 2021 Jan;20(1):29-37. doi: 10.1016/S1474-4422(20)30363-X.

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    2021-01-16 howi
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    2021-08-11 yinhl1978
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    2020-12-31 goodbing

    顶刊就是不一样,质量很高,内容精彩!学到很多

    0