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一种用于隆颏及矫正颏部后缩的透明质酸填充剂的有效性和安全性:一项多中心、前瞻性、随机对照试验。

Effectiveness and Safety of a Hyaluronic Acid Filler for Chin Augmentation and Correction of Chin Retrusion: A Multi-center, Prospective, Randomized Controlled Trial.

作者信息

Liao Zhifeng, Ma Jianxun, Bu Xi, Zhang Yanjun, Wang Shiliang, Hou Yuxin, Clément Julien, Hu Xueqing, Bo Hongliang, Zeng Ang, Yu Nanze, Luo Sheng-Kang, Li Bi

机构信息

Department of Plastic and Reconstructive Surgery, Guangdong Province, Guangdong Second Provincial General Hospital, 466 Middle Xin Gang Road, Guangzhou City, People's Republic of China.

Department of Plastic Surgery, Peking University Third Hospital, #49, North Garden Road, Haidian District, Beijing, People's Republic of China.

出版信息

Aesthetic Plast Surg. 2025 Feb;49(4):1046-1053. doi: 10.1007/s00266-024-04494-0. Epub 2024 Nov 14.

Abstract

BACKGROUND

The chin significantly influences facial aesthetics, contributing to the overall balance and harmony of the face. This study aimed to assess the effectiveness of the hyaluronic acid filler Hyamax® Volumizer for chin augmentation and correction of chin retrusion compared to a no-treatment control.

METHODS

Participants aged 18-55 years with mild to moderate chin retrusion were randomized in a 3:1 ratio to receive either the treatment group (n = 150) or control group (n = 50). Evaluations included blinded assessments using the validated Galderma Chin Retrusion Scale, Global Aesthetic Improvement Scale for aesthetic enhancement, and safety follow-up.

RESULTS

The Galderma Chin Retrusion Scale responder rate (≥1 grade improvement) was significantly higher for the treatment group (70%) compared to the control group (0%) at 6 months (p < 0.0001), and remained higher at 12 months (54.67% vs. 0%; p < 0.0001). Aesthetic improvement rates were consistently high as reported by both blinded evaluating investigator (≥89.33%) and subjects (≥91.33%). Treatment-related adverse events were mild to moderate.

CONCLUSION

Hyamax® Volumizer treatment is safe and effective when injected in the chin to treat chin retrusion, with results lasting through 1 year.

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 .

摘要

背景

下巴对面部美学有显著影响,有助于面部整体的平衡与和谐。本研究旨在评估透明质酸填充剂Hyamax® Volumizer与不治疗对照组相比,在隆下巴和矫正下巴后缩方面的有效性。

方法

将年龄在18 - 55岁、有轻度至中度下巴后缩的参与者按3:1的比例随机分组,治疗组(n = 150)或对照组(n = 50)。评估包括使用经过验证的高德美下巴后缩量表进行盲法评估、用于美学改善的全球美学改善量表以及安全性随访。

结果

在6个月时,治疗组的高德美下巴后缩量表反应率(改善≥1级)显著高于对照组(70% vs. 0%;p < 0.0001),在12个月时仍保持较高水平(54.67% vs. 0%;p < 0.0001)。盲法评估的研究者(≥89.33%)和受试者(≥91.33%)报告的美学改善率一直很高。与治疗相关的不良事件为轻度至中度。

结论

Hyamax® Volumizer注射到下巴治疗下巴后缩时安全有效,效果可持续1年。

证据水平I:本期刊要求作者为每篇文章指定证据水平。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指南www.springer.com/00266

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