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一项关于透明质酸填充剂用于颧前内侧区域填充的随机、活性对照、52周研究。

A Randomized, Active-Controlled, 52-Week Study of Hyaluronic Acid Fillers for Anteromedial Malar Region Augmentation.

作者信息

Huh Chang-Hun, Eom Yunae, Yang So Dam, Shin Jung Won, Seo Kyle Koo-Il

机构信息

Department of Dermatology, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.

Life Sciences, LG Chem, Ltd., Seoul, Republic of Korea.

出版信息

Plast Reconstr Surg Glob Open. 2020 Feb 26;8(2):e2648. doi: 10.1097/GOX.0000000000002648. eCollection 2020 Feb.

DOI:10.1097/GOX.0000000000002648
PMID:32309093
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7159933/
Abstract

BACKGROUND

Hyaluronic acid (HA) fillers for volume augmentation in the anteromedial malar region of Asians have been popular for many years. However, studies on their long-term effectiveness are lacking. This study aimed to evaluate the effectiveness and safety of HA fillers injected into the anteromedial malar region for volume augmentation for up to 52 weeks.

METHODS

Each anteromedial malar region of the subjects was treated with YVOIRE Contour (YVO) in one side and Restylane Sub-Q (RES) in the other and followed up at weeks 2, 14, 26, and 52. The volume using the mid-face aesthetic scale (MFAS) ranging from 0 (full) to 4 (very severely sunken) and the subject's satisfaction and adverse events were evaluated.

RESULTS

Total 83 subjects were randomized and treated with YVO and RES. The LS means (standard error) of MFAS score in the YVO and RES groups were both 2.56 (0.05) at baseline, 1.32 (0.07) and 1.39 (0.07) at week 26, and 1.84 (0.10) and 1.89 (0.10) at week 52, respectively. The difference in the LS mean of MFAS score between the groups at week 26 was 0.07 (95% confidence interval, 0.01-0.12), showing the non-inferiority of YVO to RES. About 70% of subjects were still satisfied with the results at week 52. No specific safety concern was detected.

CONCLUSIONS

The HA fillers injected for the anteromedial malar augmentation maintained the volume well for up to 52 weeks. Additionally, both YVO and RES show similar effectiveness and safety profiles.

摘要

背景

透明质酸(HA)填充剂用于亚洲人颧骨前内侧区域的容量增加已流行多年。然而,缺乏关于其长期有效性的研究。本研究旨在评估注射到颧骨前内侧区域用于容量增加长达52周的HA填充剂的有效性和安全性。

方法

受试者的每个颧骨前内侧区域一侧用伊婉致美(YVO)治疗,另一侧用瑞蓝唯瑅(RES)治疗,并在第2、14、26和52周进行随访。使用从0(饱满)到4(非常严重凹陷)的中面部美学量表(MFAS)评估容量、受试者满意度和不良事件。

结果

总共83名受试者被随机分组并用YVO和RES治疗。YVO组和RES组MFAS评分的最小二乘均值(标准误)在基线时均为2.56(0.05),在第26周时分别为1.32(0.07)和1.39(0.07),在第52周时分别为1.84(0.10)和1.89(0.10)。两组在第26周时MFAS评分的最小二乘均值差异为0.07(95%置信区间,0.01 - 0.12),表明YVO不劣于RES。在第52周时约70%的受试者仍对结果满意。未发现特定的安全问题。

结论

注射用于颧骨前内侧增大的HA填充剂在长达52周内很好地维持了容量。此外,YVO和RES均显示出相似的有效性和安全性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c9b4/7159933/64fd246bce57/gox-8-e2648-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c9b4/7159933/f7eac34aed62/gox-8-e2648-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c9b4/7159933/5680e28c8994/gox-8-e2648-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c9b4/7159933/2f3b73643720/gox-8-e2648-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c9b4/7159933/0fe3ec85ba66/gox-8-e2648-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c9b4/7159933/64fd246bce57/gox-8-e2648-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c9b4/7159933/f7eac34aed62/gox-8-e2648-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c9b4/7159933/5680e28c8994/gox-8-e2648-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c9b4/7159933/2f3b73643720/gox-8-e2648-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c9b4/7159933/0fe3ec85ba66/gox-8-e2648-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c9b4/7159933/64fd246bce57/gox-8-e2648-g005.jpg

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