Guerzoni Simona, Pellesi Lanfranco, Baraldi Carlo, Cainazzo Michela Maria, Negro Andrea, Martelletti Paolo, Pini Luigi Alberto
Headache and Drug Abuse Research Centre, Policlinico Hospital, Department of Diagnostic Medicine, Clinical and Public Health, University of Modena e Reggio Emilia, Modena, Italy.
Regional Referral Headache Centre, Sant'Andrea Hospital, Department of Clinical and Molecular Medicine, Sapienza University, Rome, Italy.
Front Neurol. 2017 Nov 3;8:586. doi: 10.3389/fneur.2017.00586. eCollection 2017.
Chronic migraine (CM) affects about the 2% of the general population and it has been recognized as one of the most-disabling conditions worldwide by the World Health Organization. CM is often associated with the overuse of abortive medication, which determines the worsening of headache itself and the development of a secondary headache called medication overuse headache. The management of these associated conditions is difficult, but a growing amount of evidence is pointing out the effectiveness and the good safety profile of OnabotulinumtoxinA (OnabotA). Despite this, data on OnabotA effects and safety in long-term use lack. The purpose of the present article is to retrospectively assess the efficacy and safety of OnabotA in a cohort of chronic migraineurs with drug overuse from the 18th month of treatment until the third year.
90 chronic migraineurs with medication overuse were enrolled between January 2013 and February 2017. All patients were treated with OnabotA according to PREEMPT dictates. Before every injection session the headache index, the analgesic consumption, the visual analog scale for pain score, the 36-items short form health survey questionnaire score, the 6-items headache impact test (HIT-6) score and the Zung self-rating anxiety and depression scale scores were collected. Adverse events were carefully registered. A simple linear regression was performed to explore the mean changes in the abovementioned parameters for a single injection session and mean comparison tests were performed using the one-way analysis of variance followed by Tukey-Kramer post-hoc test.
A significantly improvement for a single injection was registered for all the above-mentioned parameters. Headache index, analgesic consumption, visual analog pain scale, and 6-items HIT-6 scores were significantly lower than baseline from the 18th month of treatment onwards. The 36-items short form health survey questionnaire scores were significantly higher than baseline at every injections session from the 18th months onwards. Zung scales did not change. No serious adverse events were assessed and no adverse events-related drop-outs were seen.
OnabotA effectiveness and safety last until 3 years of therapy, raising the possibility of the use of this therapy even for many years in CM prevention.
慢性偏头痛（CM）影响着约2%的普通人群，世界卫生组织已将其认定为全球致残性最强的疾病之一。CM常与过度使用缓解药物有关，这会导致头痛本身恶化，并引发一种名为药物过量使用性头痛的继发性头痛。这些相关病症的治疗颇具难度，但越来越多的证据表明A型肉毒毒素（OnabotA）具有有效性和良好的安全性。尽管如此，关于OnabotA长期使用的效果和安全性的数据仍很缺乏。本文的目的是回顾性评估OnabotA在一组慢性偏头痛且药物过量使用患者中从治疗第18个月至第三年的疗效和安全性。
2013年1月至2017年2月期间纳入了90例药物过量使用的慢性偏头痛患者。所有患者均按照PREEMPT指南接受OnabotA治疗。在每次注射前，收集头痛指数、镇痛药消耗量、视觉模拟疼痛评分、36项简短健康调查问卷评分、6项头痛影响测试（HIT-6）评分以及zung自评焦虑和抑郁量表评分。仔细记录不良事件。进行简单线性回归以探究单次注射时上述参数的平均变化，并使用单因素方差分析及随后的Tukey-Kramer事后检验进行均值比较测试。
上述所有参数在单次注射后均有显著改善。从治疗第18个月起，头痛指数、镇痛药消耗量、视觉模拟疼痛量表评分以及6项HIT-6评分均显著低于基线水平。从第18个月起，每次注射时36项简短健康调查问卷评分均显著高于基线水平。zung量表未发生变化。未评估到严重不良事件，也未出现与不良事件相关的退出情况。
OnabotA的有效性和安全性可持续至3年治疗期，这增加了在CM预防中使用该疗法多年的可能性。
