Santoro Antonio, Copetti Massimiliano, Miscio Anna M, Leone Maurizio A, Fontana Andrea
Unit of Neurology, Fondazione IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, FG, Italy.
Unit of Biostatistics, Fondazione IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, FG, Italy.
Neurol Sci. 2020 Jul;41(7):1809-1820. doi: 10.1007/s10072-020-04283-y. Epub 2020 Feb 12.
OnabotulinumtoxinA (BoNT-A) was proved effective and safe in chronic migraine (CM) prevention by the Phase III Research Evaluating Migraine Prophylaxis (PREEMPT) and Phase IV Chronic migraine OnabotulinuMtoxinA Prolonged Efficacy open-Label (COMPEL) trials over 1 and 2 years of treatment, respectively. Real-life studies highlighted BoNT-A sustained benefits up to 3 years of administration. Aim of this retrospective real-life study was observing within a 4-year timeframe the progress of a consecutive series of CM patients treated with BoNT-A and evaluating whether long-term quarterly treatment (up to 16 cycles) confirms the outcomes of previous studies over shorter periods of therapy.
One hundred nine chronic migraineurs were quarterly treated with BoNT-A according to the PREEMPT paradigm. Headache days and hours, analgesics intake and latency time together with disability were analysed at baseline, thereafter bi-annually up to 48 months. Patient responsiveness (improvement in monthly headache days and hours versus baseline) was computed at each study timepoint.
A significant overall decrease from baseline to the 48-month assessment (p < 0.001) was evidenced for the mean number of monthly headache days and hours, analgesics intake and latency time. Severe disability cases significantly decreased at 6 months (p < 0.001), and a progressive shift towards lower degrees of disability was observed at each subsequent timepoint. A gradual percentage increase of responsive cases was observed as treatment was repeated over time. Transitory neck pain was reported in 6 cases.
This study appears to reconfirm the benefits of long-lasting CM prevention with BoNT-A, thus supporting quarterly treatment with BoNT-A over several year.
在评估偏头痛预防的III期研究（PREEMPT）和IV期慢性偏头痛肉毒杆菌毒素A长期疗效开放标签研究（COMPEL）中，分别经过1年和2年的治疗，已证实A型肉毒毒素（BoNT-A）在预防慢性偏头痛（CM）方面有效且安全。现实生活研究强调了BoNT-A在长达3年的给药期内具有持续益处。这项回顾性现实生活研究的目的是，在4年时间范围内观察连续一系列接受BoNT-A治疗的CM患者的病情进展，并评估长期每季度治疗（最多16个周期）是否能证实先前较短治疗期研究的结果。
109名慢性偏头痛患者按照PREEMPT方案每季度接受BoNT-A治疗。在基线时分析头痛天数和小时数、镇痛药摄入量、潜伏期以及残疾情况，此后每半年分析一次，直至48个月。在每个研究时间点计算患者反应性（每月头痛天数和小时数相对于基线的改善情况）。
从基线到48个月评估，每月头痛天数和小时数、镇痛药摄入量以及潜伏期的平均数均有显著总体下降（p < 0.001）。严重残疾病例在6个月时显著减少（p < 0.001），并且在随后的每个时间点都观察到向较低残疾程度的逐渐转变。随着治疗的重复进行，反应性病例的百分比逐渐增加。有6例报告了短暂性颈部疼痛。
本研究似乎再次证实了BoNT-A预防CM的长期益处，从而支持在数年时间里每季度使用BoNT-A进行治疗。
