■现实世界的研究表明,在慢性偏头痛(CM)的长期和长达4年的治疗中,OnabotulinumtoxinA(BoNTA)具有持续的治疗效果和良好的安全性。这项研究旨在评估在现实生活中治疗5年后,BoNTA在CM中的安全性和有效性。
■我们在19个西班牙头痛诊所中对CM患者与BoNTA治疗的关系超过5年进行了回顾性图表回顾。我们排除了由于缺乏疗效或耐受性差而停止治疗的患者。
■489例患者[平均年龄49岁,82.8%女性]。偏头痛的平均发病年龄为21.8岁;患者的CM平均为6.4年(20.8%符合先兆标准)。在基线,患者报告平均每月头痛日(MHD)为24.7天,每月偏头痛日(MMD)为15.7天.关于有效性,应答率为59.1%,平均减少MMD为9.4天(15.7~6.3天;p<0.001).MHD也减少了14.9天(24.7至9.8天;p<0.001)。关于副作用,17.5%的人经历了颈部疼痛,17.3%头痛,8.5%眼睑下垂,颞部肌肉萎缩7.5%,斜方肌萎缩3.2%。此外,长期暴露超过5年后,无严重不良事件(AE)或因安全性或耐受性问题而停止治疗.
■使用BoNTA治疗导致偏头痛频率持续降低,即使长期暴露超过5年,没有新的安全问题的证据。
UNASSIGNED: Real-world studies have shown the sustained therapeutic effect and favourable safety profile of OnabotulinumtoxinA (BoNTA) in the long term and up to 4 years of treatment in chronic
migraine (CM). This study aims to assess the safety profile and efficacy of BoNTA in CM after 5 years of treatment in a real-life setting.
UNASSIGNED: We performed a retrospective chart review of patients with CM in relation to BoNTA treatment for more than 5 years in 19 Spanish headache clinics. We excluded patients who discontinued treatment due to lack of efficacy or poor tolerability.
UNASSIGNED: 489 patients were included [mean age 49, 82.8% women]. The mean age of onset of
migraine was 21.8 years; patients had CM with a mean of 6.4 years (20.8% fulfilled the aura criteria). At baseline, patients reported a mean of 24.7 monthly headache days (MHDs) and 15.7 monthly
migraine days (MMDs). In relation to effectiveness, the responder rate was 59.1% and the mean reduction in MMDs was 9.4 days (15.7 to 6.3 days; p < 0.001). The MHDs were also reduced by 14.9 days (24.7 to 9.8 days; p < 0.001). Regarding the side effects, 17.5% experienced neck pain, 17.3% headache, 8.5% eyelid ptosis, 7.5% temporal muscle atrophy and 3.2% trapezius muscle atrophy. Furthermore, after longer-term exposure exceeding 5 years, there were no serious adverse events (AE) or treatment discontinuation because of safety or tolerability issues.
UNASSIGNED: Treatment with BoNTA led to sustained reductions in
migraine frequency, even after long-term exposure exceeding 5 years, with no evidence of new safety concerns.