一项多中心、随机、评估盲、无治疗对照研究:YVOIRE Y-Solution 720:一种用于中脸容积缺陷的透明质酸填充剂。

IF 2.8 3区 医学 Q2 SURGERY
Nanze Yu, Wenyun Ting, Jinhua Xu, Wenyu Wu, Hang Wang, Jufang Zhang, Jiaming Sun, Zhiqi Hu, Sufan Wu, Xiaojun Wang
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引用次数: 0

摘要

背景:中脸体积不足是一个常见的美学问题,可以通过真皮填充物来解决。YVOIRE Y-Solution 720 (YYS720)是一种基于透明质酸(HA)的填充剂,专为面部中部填充而设计。本研究旨在评价YYS720改善中面体积的有效性和安全性。方法:轻度至重度中脸体积损失的亚洲参与者被随机分配接受YYS720注射(n = 173)或不接受治疗(n = 65)。YYS720组和对照组分别在4、14和26周时使用亚洲面孔中脸体积缺陷严重程度评定量表(MFVDA-SRS)评估中脸体积。此外,对于YYS720,在最后一次注射后52周评估中面体积。结果:在第26周,YYS720组MFVDA-SRS评分降低≥1级的参与者比例为82.0%(137/167名参与者),对照组为5.1%(3/59名参与者),组间差异(95%置信区间,CI)为77.0%(66.8,84.0),表明YYS7720在中脸隆胸方面的改善具有统计学意义。在第52周,YYS720组MFVDA-SRS评分降低≥1级的参与者比例为76.2%。在截至第26周的所有时间点中,YYS720组参与者的全球审美改善量表(GAIS)应答率一直很高。没有发现特别的安全隐患。常见的治疗部位反应包括肿胀、压痛和疼痛,通常是轻微和短暂的。结论:本研究支持YVOIRE Y-Solution 720是中面部体积增大的有效和安全的选择。证据等级i:本刊要求作者为每篇文章指定证据等级。有关这些循证医学评级的完整描述,请参阅目录或在线作者说明www.springer.com/00266。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A Multicenter, Randomized, Evaluator-Blind, No-Treatment Controlled Study of YVOIRE Y-Solution 720: A Volumizing Hyaluronic Acid Filler for Midface Volume Deficit.

Background: Midface volume deficiency is a common aesthetic concern that can be addressed with dermal fillers. YVOIRE Y-Solution 720 (YYS720) is a hyaluronic acid (HA)-based filler designed for midface augmentation. This study aimed to evaluate the effectiveness and safety of YYS720 in improving midface volume.

Methods: Asian participants with mild to severe midface volume loss were randomly assigned to receive either YYS720 injection (n = 173) or no treatment (control, n = 65). Midface volume was evaluated at 4, 14, and 26 weeks using Midface Volume Deficit Severity Rating Scale for Asian Faces (MFVDA-SRS) for both YYS720 and control groups. Additionally, for YYS720, midface volume was evaluated 52 weeks after the last injection.

Results: At Week 26, the proportion of participants with ≥ 1-grade reduction on the MFVDA-SRS score was 82.0% (137/167 participants) for YYS720 and 5.1% (3/59 participants) for control with difference (95% confidence interval, CI) between the groups of 77.0% (66.8, 84.0), demonstrating the statistically significant improvement of YYS7720 in midface augmentation. At Week 52, the proportion of participants with ≥1-grade reduction on the MFVDA-SRS score was 76.2% for YYS720 group. Global Aesthetic Improvement Scale (GAIS) responder rates by participants were consistently high in YYS720 group across all time points up to Week 26. No specific safety concern was detected. Common treatment site responses included swelling, tenderness, and pain, which were generally mild and transient.

Conclusions: This study supports that YVOIRE Y-Solution 720 is an effective and safe option for midface volume augmentation.

Level of evidence i: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

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来源期刊
CiteScore
4.40
自引率
25.00%
发文量
479
审稿时长
3 months
期刊介绍: Aesthetic Plastic Surgery is a publication of the International Society of Aesthetic Plastic Surgery and the official journal of the European Association of Societies of Aesthetic Plastic Surgery (EASAPS), Società Italiana di Chirurgia Plastica Ricostruttiva ed Estetica (SICPRE), Vereinigung der Deutschen Aesthetisch Plastischen Chirurgen (VDAPC), the Romanian Aesthetic Surgery Society (RASS), Asociación Española de Cirugía Estética Plástica (AECEP), La Sociedad Argentina de Cirugía Plástica, Estética y Reparadora (SACPER), the Rhinoplasty Society of Europe (RSE), the Iranian Society of Plastic and Aesthetic Surgeons (ISPAS), the Singapore Association of Plastic Surgeons (SAPS), the Australasian Society of Aesthetic Plastic Surgeons (ASAPS), the Egyptian Society of Plastic and Reconstructive Surgeons (ESPRS), and the Sociedad Chilena de Cirugía Plástica, Reconstructiva y Estética (SCCP). Aesthetic Plastic Surgery provides a forum for original articles advancing the art of aesthetic plastic surgery. Many describe surgical craftsmanship; others deal with complications in surgical procedures and methods by which to treat or avoid them. Coverage includes "second thoughts" on established techniques, which might be abandoned, modified, or improved. Also included are case histories; improvements in surgical instruments, pharmaceuticals, and operating room equipment; and discussions of problems such as the role of psychosocial factors in the doctor-patient and the patient-public interrelationships. Aesthetic Plastic Surgery is covered in Current Contents/Clinical Medicine, SciSearch, Research Alert, Index Medicus-Medline, and Excerpta Medica/Embase.
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