肉毒毒素 A（保妥适®）预防治疗慢性偏头痛的有效性：基于 10 年真实世界数据的荟萃分析。

Effectiveness of onabotulinumtoxinA (BOTOX®) for the preventive treatment of chronic migraine: A meta-analysis on 10 years of real-world data.

机构信息

Pain Department and FHU InovPain, Côte Azur University, Centre Hospitalier Universitaire de Nice, Nice, France.

INSERM U1107 Migraine and Trigeminal Pain, Auvergne University, Clermont-Ferrand, France.

出版信息

Cephalalgia. 2022 Dec;42(14):1543-1564. doi: 10.1177/03331024221123058. Epub 2022 Sep 8.

BACKGROUND

This meta-analysis evaluated the real-world effectiveness of onabotulinumtoxinA (BOTOX®), the first preventive treatment FDA-approved specifically for chronic migraine in 2010.

METHODS

We systematically reviewed onabotulinumtoxinA observational data in chronic migraine published between 1 January 2010 and 31 March 2021. Random-effects models evaluated available data for primary and secondary endpoints defined in onabotulinumtoxinA pivotal trials at approximately 24 weeks and 52 weeks.

RESULTS

Of the 44 full-text eligible studies (29 prospective; 13 retrospective; 2 other), seven evaluated change from baseline (mean[confidence interval]) at ∼24 weeks and ∼52 weeks, respectively, for onabotulinumtoxinA in: : (-10.64 [-12.31, -8.97]; -10.32 [-14.92, -5.73]); (-7.40 [-13.04, -1.77]; overlapping CIs at 52 weeks); (-11.70 [-13.86, -9.54]); -11.80 [14.70, -8.90]); and (MSQ; 23.60 [CI: 21.56, 25.64]; 30.90 [CI: 28.29, 33.51]). At ∼24 weeks onabotulinumtoxinA showed of 44.74 [28.50, 60.99] and of 46.57% [29.50%, 63.65%]. A sensitivity analysis at study-end suggested durability of onabotulinumtoxinA effectiveness on MSQ.

CONCLUSION

The meta-analysis reflecting real-world practice broadly corroborated with evidence from pivotal and long-term open-label studies of onabotulinumtoxinA in chronic migraine preventive treatment.

背景

本荟萃分析评估了肉毒毒素 A（BOTOX®）的真实世界疗效，这是 2010 年 FDA 批准的首个专门用于慢性偏头痛的预防性治疗药物。

方法

我们系统地回顾了 2010 年 1 月 1 日至 2021 年 3 月 31 日期间发表的关于肉毒毒素 A 治疗慢性偏头痛的观察性研究数据。随机效应模型评估了在大约 24 周和 52 周时，在肉毒毒素 A 关键试验中定义的主要和次要终点的可用数据。

结果

在 44 篇全文符合条件的研究中（29 项前瞻性研究，13 项回顾性研究，2 项其他研究），7 项研究分别评估了肉毒毒素 A 在大约 24 周和 52 周时从基线的变化（平均值[置信区间]）：（-10.64 [-12.31，-8.97]）；（-10.32 [-14.92，-5.73]）；（-7.40 [-13.04，-1.77]）；（-11.70 [-13.86，-9.54]）；（-11.80 [14.70，-8.90]）；和（MSQ；23.60 [CI：21.56，25.64]；30.90 [CI：28.29，33.51]）。在大约 24 周时，肉毒毒素 A 显示了 44.74% [28.50%，60.99%]的有效性和 46.57% [29.50%，63.65%]的应答率。研究结束时的敏感性分析表明，肉毒毒素 A 在 MSQ 上的有效性具有持久性。