多中心,随机分面试验的交叉连接的氨酸填充剂与利多卡因用于鼻皮折叠校正
Konstantin Frank1, Jeanine Downie2, Michael Gold3
1physician, Department of Plastic, Hand and Reconstructive Surgery, University Hospital Regensburg, Regensburg, Germany; and is an evidence-based medicine editor for Aesthetic Surgery Journal.
Aesthetic surgery journal
|August 1, 2025
概括
公主® FILLER 利多卡因 (PFL) 是Juvéderm® Ultra XC (JUXC) 的安全有效替代品,用于减少鼻唇. 这两种 Hyaluronic 酸填充剂在分裂面部研究中表现出可比的结果.
科学领域:
- 皮肤病学 皮肤病学
- 审美医学是一种美学医学.
- 整形外科 整形外科 整形外科
背景情况:
- 鼻皮 (NLFs) 是衰老的常见迹象,经常使用氨酸皮肤填充剂来解决.
- 公主® FILLER 利多卡因 (PFL) 和Juvéderm® Ultra XC (JUXC) 是广泛用于NLF校正的HA填充剂.
研究的目的:
- 为了比较PFL与JUXC在治疗中度至重度NLF的疗效和安全性.
- 为了评估PFL作为一个不劣等的替代品JUXC使用分割面设计.
主要方法:
- 一个随机的,受试者和调查者盲目的多中心研究.
- 试验对象一边接受PFL,另一边接受JUXC,使用NLF-SRS评估NLF的严重程度.
- 主要终点:在24周的NLF-SRS响应者比例;二次终点包括摄影和研究者评估,GAIS,安全和受试者满意度 (FACE-Q).
主要成果:
- 在第24周,PFL不低于JUXC (82.2% vs 81.9%的响应者).
- 两种填充剂之间的二次疗效评估和患者满意度得分是可比的.
- 不良事件主要为轻度至中度,严重治疗出现的不良事件的发病率很低 (1.1%).
结论:
- 在纠正中度至严重的鼻皮方面,PFL的疗效和安全性与JUXC相美.
- PFL是NLF治疗的可行替代方案,患者满意度很高.
- 分裂面研究设计证实了PFL在这种美学应用中的非劣势性.
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