Negro Andrea, Curto Martina, Lionetto Luana, Martelletti Paolo
Department of Clinical and Molecular Medicine, Sapienza University, Rome, Italy.
Regional Referral Headache Centre, Sant'Andrea Hospital, Rome, Italy.
J Headache Pain. 2015;17:1. doi: 10.1186/s10194-016-0591-3. Epub 2016 Jan 21.
The efficacy and safety of OnabotulinumtoxinA (BOTOX®) in adults with chronic migraine (CM) were demonstrated in the PREEMPT program. However, the dosage used in this study was flexible from 155 U to 195 U at the physician's discretion. Therefore, the objective of this prospective study was to compare the efficacy and safety of OnabotulinumtoxinA 195 U vs. 155 U for the treatment of CM and medication overuse headache (MOH) during a 2-year period.
We prospectively evaluated the mean reduction in headache days, migraine days, acute pain medication intake days and Headache Impact Test (HIT)-6 score in 172 patients injected with OnabotulinumtoxinA 195 U. Successively, we compared the efficacy measures with data of 155 patients injected with OnabotulinumtoxinA 155 U and followed up for 2 years. All patients were affected by CM and MOH, and failed one or more previous detoxification and preventative therapies.
Both OnabotulinumtoxinA 195 U and 155 U reduced significantly the number of headache and migraine days, acute pain medication intake days and HIT-6 score, when compared with the baseline measures. Nevertheless, OnabotulinumtoxinA 195 U proved to be superior of 155 U in all efficacy measures since the first injection and for all the 2 years of treatment, with the exception of the reduction in pain medication intake days that resulted significantly larger with 195 U only after the 4th injection. The safety and tolerability of the two doses were similar and treatment related adverse events were transient and mild-moderate.
This study represents the largest and longest post-marketing studies of doses comparison with OnabotulinumtoxinA in a real-life clinical setting. Here, we demonstrate the superior efficacy of OnabotulinumtoxinA 195 U compared to 155 U in CM patients with MOH during a 2-year treatment period with similar safety and tolerability profile.
在PREEMPT项目中证实了A型肉毒毒素（保妥适®）用于慢性偏头痛（CM）成人患者的有效性和安全性。然而，本研究中使用的剂量在155单位至195单位之间可由医生酌情灵活调整。因此，这项前瞻性研究的目的是比较2年内195单位与155单位A型肉毒毒素治疗CM和药物过量使用性头痛（MOH）的有效性和安全性。
我们前瞻性评估了172例注射195单位A型肉毒毒素患者的头痛天数、偏头痛天数、急性止痛药物摄入天数和头痛影响测试（HIT）-6评分的平均减少情况。随后，我们将这些疗效指标与155例注射155单位A型肉毒毒素并随访2年患者的数据进行了比较。所有患者均患有CM和MOH，且之前一种或多种排毒和预防性治疗均失败。
与基线指标相比，195单位和155单位的A型肉毒毒素均显著减少了头痛和偏头痛天数、急性止痛药物摄入天数以及HIT-6评分。然而，自首次注射起及整个2年治疗期间，在所有疗效指标方面，195单位A型肉毒毒素均优于155单位，不过止痛药物摄入天数的减少情况除外，仅在第4次注射后，195单位的减少幅度才显著大于155单位。两种剂量的安全性和耐受性相似，与治疗相关的不良事件短暂且为轻至中度。
本研究是现实临床环境中关于A型肉毒毒素剂量比较的最大规模、最长时间的上市后研究。在此，我们证明了在2年治疗期内，对于患有MOH的CM患者，195单位A型肉毒毒素比155单位具有更高的疗效，且安全性和耐受性相似。
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