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中文译文:在亚洲受试者中,使用一种新型可吸收性聚己内酯微球复合透明质酸钠凝胶进行颏部填充和颏后缩治疗的前瞻性、随机、对照、观察者设盲研究。

Chin Augmentation and Treatment of Chin Retrusion with a Flexible Hyaluronic Acid Filler in Asian Subjects: A Randomized, Controlled, Evaluator-Blinded Study.

机构信息

Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.

Beijing Hospital, Beijing, China.

出版信息

Aesthetic Plast Surg. 2024 Mar;48(5):1030-1036. doi: 10.1007/s00266-023-03812-2. Epub 2024 Feb 5.

Abstract

BACKGROUND

Aesthetic improvement of the chin is increasingly requested by patients, including those of Chinese origin.

METHODS

A randomized, evaluator-blinded, no-treatment controlled study evaluated the effectiveness and safety of a flexible hyaluronic acid (HA) filler, Restylane Defyne (HA), in the correction of chin retrusion in a Chinese adult population over 12 months after treatment. On Day 1, subjects were randomized 3:1 into two groups, HA or delayed-treatment controls, and those in the HA group were administered treatment. An optional touch-up treatment was administered 1 month after treatment to obtain optimal chin augmentation. The initially untreated control group was offered delayed-treatment after 6 months (including 1-month touch-up).

RESULTS

HA was superior to no-treatment in improving chin retrusion according to the blinded evaluator at 6 months [Galderma Chin Retrusion Scale (GCRS) responder rate (≥ 1-point improvement from baseline) of 81% vs. 5% for untreated controls; p < 0.001, meeting the primary effectiveness objective. A majority of subjects maintained improvement at 12 months (61% in the HA group). All subjects reported satisfaction with results at 6 months after treatment with HA and aesthetic improvement rates per the global aesthetic improvement scale (GAIS) were high for 12 months following treatment, with an acceptable safety profile.

CONCLUSIONS

These results demonstrated HA to be effective and safe for the correction of mild-to-moderate chin retrusion in Chinese subjects, confirming findings previously observed in a western population.

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

包括华裔患者在内,越来越多的患者要求改善颏部美观。

方法

一项随机、评估者设盲、无治疗对照的研究评估了一种新型、柔软的透明质酸(HA)填充剂——瑞蓝·唯瑅(Defyne)在改善颏后缩方面的有效性和安全性,共纳入了 12 个月时接受治疗的中国成年人群。在第 1 天,受试者按 3:1 随机分为 HA 组和延迟治疗对照组,HA 组接受治疗。在治疗后 1 个月时进行了可选的补充治疗,以获得最佳的颏部填充效果。最初未接受治疗的对照组在 6 个月后(包括 1 个月的补充治疗)开始接受延迟治疗。

结果

根据盲法评估者,与未治疗组相比,HA 组在改善颏后缩方面具有显著优势,6 个月时的 Galderma Chin Retrusion Scale(GCRS)应答率(较基线改善≥1 分)为 81%,而未治疗对照组为 5%(p<0.001,达到了主要有效性终点。大多数受试者在 12 个月时仍保持改善(HA 组为 61%)。所有受试者在 HA 治疗 6 个月后报告对结果满意,且在治疗后 12 个月时的整体美学改善率(GAIS)较高,具有可接受的安全性。

结论

这些结果表明,HA 可有效、安全地矫正中国受试者的轻至中度颏后缩,与先前在西方人群中观察到的结果一致。

证据等级 I:本杂志要求作者为每篇文章指定一个证据等级。有关这些循证医学评级的完整描述,请参考目录或在线作者指南 www.springer.com/00266

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/87f5/10980616/7c9f527b1d7f/266_2023_3812_Fig1_HTML.jpg

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