Wake Forest School of Medicine, Winston-Salem, NC, USA.
University of Southern Denmark, Odense, Denmark.
Ann Pharmacother. 2021 Mar;55(3):354-361. doi: 10.1177/1060028020943527. Epub 2020 Jul 22.
PrabotulinumtoxinA-xvfs (Jeuveau), a botulinum toxin type A, was approved by the Food and Drug Administration for the temporary improvement in the appearance of moderate-to-severe glabellar lines in February 2019. This article will review phase II and III clinical trials to assess the efficacy, safety, and clinical application of this novel, aesthetic-only drug.
A systematic literature review was performed using the terms "glabellar lines AND prabotulinumtoxinA" in the PubMed database. ClinicalTrials.gov was searched to identify nonpublished studies.
Articles written in English between November 2019 and June 2020 discussing phase II and phase III clinical trials were evaluated.
By the primary efficacy end point on day 30, more patients achieved a greater than 2-point improvement on the Glabellar Line Scale (GLS) at maximum frown compared with baseline on day 0. The proportions of participants who responded to treatment with prabotulinumtoxinA were 67.5% and 70.4% versus 1.2% and 1.3% in placebo groups across 2 identical clinical trials ( < 0.001). Patients receiving prabotulinumtoxinA experienced greater improvement in GLS at maximum frown on day 30 (87.2%) compared with onabotulinumtoxinA (82.8%) and placebo (4.2%; < 0.001). PrabotulinumtoxinA was well tolerated across all studies.
This review provides a detailed analysis of the safety and efficacy of prabotulinumtoxinA-xvfs and includes special considerations to help guide patients and clinicians.
PrabotulinumtoxinA is a safe and effective new addition to the repository of available treatments for the appearance of glabellar lines.
肉毒梭菌神经毒素 A 型（PrabotulinumtoxinA-xvfs，即 Jeuveau）于 2019 年 2 月获得美国食品和药物管理局批准，用于暂时改善中重度眉间纹的外观。本文将回顾 II 期和 III 期临床试验，评估这种新型美容专用药物的疗效、安全性和临床应用。
在 PubMed 数据库中使用术语“眉间纹和 PrabotulinumtoxinA”进行系统文献回顾。在 ClinicalTrials.gov 上搜索以确定未发表的研究。
评估了 2019 年 11 月至 2020 年 6 月期间发表的讨论 II 期和 III 期临床试验的英文文章。
在第 30 天的主要疗效终点，与安慰剂组相比，更多患者在皱眉时最大程度上达到了 Glabellar Line Scale（GLS）较基线增加 2 分以上的改善。在 2 项相同的临床试验中，接受 PrabotulinumtoxinA 治疗的参与者比例分别为 67.5%和 70.4%，而安慰剂组为 1.2%和 1.3%（<0.001）。接受 PrabotulinumtoxinA 治疗的患者在第 30 天皱眉时 GLS 最大程度改善（87.2%）显著大于接受 onabotulinumtoxinA（82.8%）和安慰剂（4.2%；<0.001）。在所有研究中，PrabotulinumtoxinA 均具有良好的耐受性。
本综述详细分析了 PrabotulinumtoxinA-xvfs 的安全性和有效性，并包括特殊注意事项以帮助指导患者和临床医生。
PrabotulinumtoxinA 是治疗眉间纹的现有治疗方法的安全有效新选择。
