Schiano di Cola Francesca, Caratozzolo Salvatore, Liberini Paolo, Rao Renata, Padovani Alessandro
Neurology Unit, Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.
Neurology Unit, Spedali Civili Hospital, Brescia, Italy.
Front Neurol. 2019 Jul 10;10:678. doi: 10.3389/fneur.2019.00678. eCollection 2019.
Despite numerous studies that have investigated clinical, radiological, and biochemical response predictors, the clinical profile of those patients who might benefit from OnabotulinumtoxinA is still missing. The aim of the present study was to identify potential OnabotulinumtoxinA response predictors among several clinical characteristics and confirm OnabotulinumtoxinA efficacy and safety in chronic migraine (CM) prevention. The study was conducted at the Headache Center-Neurology Clinic-Spedali Civili Hospital of Brescia. Eighty-four consecutive CM patients were enrolled, with a mean age of 48 years (SD 9.7) and a mean disease duration of 10.1 years (SD 6.6). The mean reported headache-days frequency was 22.5 (SD 5.9) per month, while the mean number of severe headache-days was 15.2 (SD 8.9) with a mean monthly medication intake of 33.2 (SD 5.6). The clinical characteristics analyzed as potential response predictors were: gender, disease duration, migraine characteristics (location, side constancy, unilateral autonomic and neurovegetative symptoms), previous prophylactic treatments, add-on therapies, withdrawal therapies, psychiatric (anxiety and depression symptoms) comorbidities and medication overuse. A significant reduction from baseline to 3, 6, 9, and 12 month treatment cycles in total headache days, high intensity headache days and triptans consumption per month was found. Depressive symptoms and medication overuse negatively predicted OnabotulinumtoxinA outcome. Our results confirm the efficacy and safety of OnabotulinumtoxinA in CM. Depressive comorbidity and medication overuse, among all clinical variables, were the only significant response predictors. Such findings provide interesting insights regarding patients selection for OnabotulinumtoxinA treatment as, with the introduction of anti calcitonin gene-related (CGRP) monoclonal antibodies, clinicians will have to thoroughly judge and tailor among the many available therapeutic options now available. Future research might be needed to confirm our findings, in particular for its therapeutic implications.
尽管已有众多研究对临床、放射学和生化反应预测指标进行了调查，但仍不清楚哪些患者可能从A型肉毒毒素（OnabotulinumtoxinA）治疗中获益。本研究的目的是在多种临床特征中识别出可能对A型肉毒毒素有反应的预测指标，并证实A型肉毒毒素在预防慢性偏头痛（CM）方面的疗效和安全性。该研究在布雷西亚市公民医院头痛中心 - 神经科诊所进行。连续纳入了84例慢性偏头痛患者，平均年龄48岁（标准差9.7），平均病程10.1年（标准差6.6）。每月报告的头痛天数平均为22.5天（标准差5.9），而重度头痛天数平均为15.2天（标准差8.9），每月药物摄入量平均为33.2（标准差5.6）。作为潜在反应预测指标进行分析的临床特征包括：性别、病程、偏头痛特征（部位、侧别稳定性、单侧自主神经和神经植物症状）、既往预防性治疗、附加治疗、撤药治疗、精神科（焦虑和抑郁症状）合并症以及药物过度使用。从基线到治疗3、6、9和12个月周期，总头痛天数、高强度头痛天数和每月曲坦类药物消耗量均有显著减少。抑郁症状和药物过度使用对A型肉毒毒素的治疗效果有负面预测作用。我们的结果证实了A型肉毒毒素在慢性偏头痛治疗中的疗效和安全性。在所有临床变量中，抑郁合并症和药物过度使用是唯一显著的反应预测指标。这些发现为A型肉毒毒素治疗的患者选择提供了有趣的见解，因为随着抗降钙素基因相关肽（CGRP）单克隆抗体的引入，临床医生将不得不从众多现有的治疗选择中进行全面评估和个性化选择。未来可能需要进一步研究来证实我们的发现，特别是其治疗意义。
