Bratbak Daniel Fossum, Nordgård Ståle, Stovner Lars Jacob, Linde Mattias, Folvik Mari, Bugten Vegard, Tronvik Erling
Department of Neurosurgery, St. Olavs Hospital, Trondheim University Hospital, Norway Department of Neuroscience, Norwegian University of Science and Technology, Norway
Department of Neuroscience, Norwegian University of Science and Technology, Norway Department of ENT, St. Olavs Hospital, Trondheim University Hospital, Norway.
Cephalalgia. 2016 May;36(6):503-9. doi: 10.1177/0333102415597891. Epub 2015 Jul 31.
The main object of this pilot study was to investigate the safety of administering onabotulinumtoxinA (BTA) towards the sphenopalatine ganglion (SPG) in intractable chronic cluster headache. Efficacy data were also collected to provide indication on whether future placebo-controlled studies should be performed.
In a prospective, open-label, uncontrolled study, we performed a single injection of 25 IU (n = 5) or 50 IU BTA (n = 5) towards the SPG in 10 patients with intractable chronic cluster headache with a follow-up of 24 weeks. The primary outcome was adverse events (AEs) and the main efficacy outcome was attack frequency in weeks 3 and 4 post-treatment.
A total of 11 AEs were registered. There was one severe adverse event (SAE): posterior epistaxis. The number of cluster headache attacks (main efficacy outcome) was statistically significantly reduced in the intention-to-treat analysis from 18 ± 12 per week in baseline to 11 ± 14 (p = 0.038) in weeks 3 and 4, and five out of 10 patients had at least 50% reduction of attack frequency compared to baseline. The cluster attack frequency was significantly reduced for five out of six months post-treatment.
Randomised, placebo-controlled studies are warranted to establish the potential of this possible novel treatment of cluster headache.
本初步研究的主要目的是调查向蝶腭神经节（SPG）注射A型肉毒毒素（BTA）治疗顽固性慢性丛集性头痛的安全性。还收集了疗效数据，以表明未来是否应开展安慰剂对照研究。
在一项前瞻性、开放标签、非对照研究中，我们对10例顽固性慢性丛集性头痛患者的SPG进行单次注射25国际单位（n = 5）或50国际单位BTA（n = 5），随访24周。主要结局是不良事件（AE），主要疗效结局是治疗后第3周和第4周的发作频率。
共记录到11起不良事件。有1起严重不良事件（SAE）：后鼻出血。在意向性分析中，丛集性头痛发作次数（主要疗效结局）从基线时的每周18±12次在第3周和第4周时显著降至11±14次（p = 0.038），10例患者中有5例与基线相比发作频率至少降低了50%。治疗后六个月中有五个月丛集性发作频率显著降低。
有必要开展随机、安慰剂对照研究，以确定这种可能的丛集性头痛新疗法的潜力。
