慢性偏头痛中A型肉毒毒素治疗的早期管理：来自一项欧洲多中心真实世界研究的见解
Early Management of OnabotulinumtoxinA Treatment in Chronic Migraine: Insights from a Real-Life European Multicenter Study.
作者信息
Ornello Raffaele, Ahmed Fayyaz, Negro Andrea, Miscio Anna Maria, Santoro Antonio, Alpuente Alicia, Russo Antonio, Silvestro Marcello, Cevoli Sabina, Brunelli Nicoletta, Vernieri Fabrizio, Grazzi Licia, Baraldi Carlo, Guerzoni Simona, Andreou Anna P, Lambru Giorgio, Frattale Ilaria, Kamm Katharina, Ruscheweyh Ruth, Russo Marco, Torelli Paola, Filatova Elena, Latysheva Nina, Gryglas-Dworak Anna, Straburzynski Marcin, Butera Calogera, Colombo Bruno, Filippi Massimo, Pozo-Rosich Patricia, Martelletti Paolo, Sacco Simona
机构信息
Neuroscience Section, Department of Applied Clinical Sciences and Biotechnology, University of L'Aquila, Via Vetoio 1 Coppito, 67100, L'Aquila, Italy.
Department of Neurosciences, Hull University Teaching Hospitals, Hull, UK.
出版信息
Pain Ther. 2021 Jun;10(1):637-650. doi: 10.1007/s40122-021-00253-0. Epub 2021 Mar 28.
INTRODUCTION
OnabotulinumtoxinA (BT-A) quarterly was the first treatment approved specifically for chronic migraine (CM). It is unclear whether three cycles are better than two to assess early BT-A response.
METHODS
We performed a retrospective analysis on real-life prospectively collected data in 16 European headache centers. All the centers provided data on patients treated with BT-A for CM over the first three cycles of treatment. For each treatment cycle we defined patients as "good responders" if reporting a ≥ 50% reduction in monthly headache days compared with the three months before starting BT-A, "partial responders" if reporting a 30-49% reduction in monthly headache days, and "non-responders" if reporting a < 30% reduction in monthly headache days or stopping the treatment before the third cycle.
RESULTS
We included 2879 patients. Seven hundred and eighty-four (64.6%) of the 1213 patients reporting a good response during the first and/or the second cycle had a good response during the third cycle; 309 (49.3%) of the 627 patients reporting a partial response (but no good response) during the first and/or the second cycle had a good response during the third cycle; only 65 (6.3%) of the 1039 patients who did not respond during both the first two cycles achieved a good response during the third cycle. Multivariate analyses showed that partial or good response during the first or the second cycle were independently associated with good response during the third cycle.
CONCLUSIONS
Our data suggest that patients with CM responding to BT-A during the first two cycles will likely benefit from the third cycle of treatment, while the probability that non-responders to the first two cycles start responding during the third cycle is low. These results can help guide the individual decision to stop or continue treatment after the second cycle in patients who have not responded to the first two cycles.
引言
季度注射一次的A型肉毒毒素（BT-A）是首个专门获批用于治疗慢性偏头痛（CM）的疗法。目前尚不清楚评估BT-A早期反应时，三个疗程是否优于两个疗程。
方法
我们对欧洲16个头痛中心前瞻性收集的真实数据进行了回顾性分析。所有中心都提供了在BT-A治疗的前三个疗程中接受治疗的慢性偏头痛患者的数据。对于每个治疗周期，如果患者报告每月头痛天数比开始BT-A治疗前的三个月减少≥50%，则定义为“良好反应者”；如果报告每月头痛天数减少30%-49%，则定义为“部分反应者”；如果报告每月头痛天数减少<30%或在第三个疗程前停止治疗，则定义为“无反应者”。
结果
我们纳入了2879例患者。在第一个和/或第二个疗程中报告有良好反应的1213例患者中，784例（64.6%）在第三个疗程中仍有良好反应；在第一个和/或第二个疗程中报告有部分反应（但无良好反应）的627例患者中，309例（49.3%）在第三个疗程中有良好反应；在前两个疗程中均无反应的1039例患者中，只有65例（6.3%）在第三个疗程中获得了良好反应。多变量分析显示，第一个或第二个疗程中的部分或良好反应与第三个疗程中的良好反应独立相关。
结论
我们的数据表明，在前两个疗程中对BT-A有反应的慢性偏头痛患者可能会从第三个疗程的治疗中获益，而在前两个疗程中无反应的患者在第三个疗程开始有反应的可能性较低。这些结果有助于指导对前两个疗程无反应的患者在第二个疗程后决定是否停止或继续治疗。
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