Department of Anesthesia, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Boston, MA, USA.
Department of Anesthesia, Harvard Medical School, Boston, MA, USA.
J Headache Pain. 2023 Mar 16;24(1):26. doi: 10.1186/s10194-023-01560-x.
The goal of this observational, open-label, cohort study was to determine whether prophylactic migraine treatment with galcanezumab, a peripherally acting drug, alters the incidence of premonitory symptoms, and/or occurrence of headache after exposure to triggers or aura episodes in treatment-responders (≥ 50% reduction in monthly migraine days [MMD]), super-responders (≥ 70%), non-responders (< 50%) and super non-responders (< 30%).
Participants were administered electronic daily headache diaries to document migraine days and associated symptoms one month before and during the three months of treatment. Questionnaires were used to identify conscious prodromal and trigger events that were followed by headache prior to vs. after 3 months of treatment.
After 3 months of galcanezumab treatment, (a) the incidence of premonitory symptoms that were followed by headache decreased by 48% in the 27 responders vs. 28% in the 19 non-responders, and by 50% in the 11 super-responders vs. 12% in the 8 super non-responders; (b) the incidence of visual and sensory aura that were followed by headache was reduced in responders, non-responders, and super-responders, but not in super non-responders; (c) the number of triggers followed by headache decreased by 38% in responders vs. 13% in non-responders, and by 31% in super-responders vs. 4% in super non-responders; and (d) some premonitory symptoms (e.g., cognitive impairment, irritability, fatigue) and triggers (e.g., stress, sleeping too little, bright light, aura) were followed by headache only in super non-responders.
Mechanistically, these findings suggest that even a mild decrease in migraine frequency is sufficient to partially reverse the excitability and responsivity of neurons involved in the generation of certain triggers and potentially premonitory symptoms of migraine.
ClinicalTrials.gov: NCT04271202. Registration date: February 10, 2020.
本观察性、开放标签、队列研究的目的是确定预防性偏头痛治疗是否会改变预防性偏头痛治疗药物加巴喷丁的作用,该药物是一种外周作用药物,在治疗反应者(每月偏头痛天数 [MMD] 减少≥50%)、超级反应者(≥70%)、无反应者(<50%)和超级无反应者(<30%)中,是否会改变先兆症状的发生率,以及/或在接触触发因素或先兆发作后头痛的发生。
参与者每月头痛日记进行电子记录,记录治疗前一个月和治疗期间三个月的偏头痛天数和相关症状。问卷用于识别有意识的前驱症状和触发事件,这些事件在治疗前和治疗后 3 个月内均会导致头痛。
在加巴喷丁治疗 3 个月后,(a)在 27 名反应者中,先兆症状后头痛的发生率下降了 48%,而在 19 名无反应者中则下降了 28%,在 11 名超级反应者中下降了 50%,而在 8 名超级无反应者中则下降了 12%;(b)反应者、无反应者和超级反应者的视觉和感觉先兆后头痛发生率降低,但超级无反应者无变化;(c)在反应者中,头痛的触发因素数量减少了 38%,而在无反应者中则减少了 13%,在超级反应者中则减少了 31%,而在超级无反应者中则减少了 4%;(d)一些前驱症状(如认知障碍、易怒、疲劳)和触发因素(如压力、睡眠过少、强光、先兆)仅在超级无反应者中导致头痛。
从机制上讲,这些发现表明,即使偏头痛发作频率略有降低,也足以部分逆转参与某些触发因素和潜在偏头痛先兆症状产生的神经元的兴奋性和反应性。
ClinicalTrials.gov:NCT04271202。注册日期:2020 年 2 月 10 日。