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一项关于用于中面部容积不足的填充用透明质酸的多中心、单盲随机对照研究:2年的患者报告结局

A Multicenter, Single-Blind Randomized, Controlled Study of a Volumizing Hyaluronic Acid Filler for Midface Volume Deficit: Patient-Reported Outcomes at 2 Years.

作者信息

Few Julius, Cox Sue Ellen, Paradkar-Mitragotri Deepali, Murphy Diane K

机构信息

Dr Few is Clinical Professor of Surgery, Division of Plastic Surgery, University of Chicago Pritzker School of Medicine, Chicago, Illinois. Dr Cox is Assistant Clinical Professor, University of North Carolina, Chapel Hill, North Carolina; and is Supervising Physician, Dermatology Program, Duke University, Durham, North Carolina. Dr Paradkar-Mitragotri was the Manager of Biostatistics at the time of this study and is a former employee of Allergan, Inc., Irvine, California, and Ms Murphy is the Director of Clinical Development Submissions at Allergan, Inc., Irvine, California.

出版信息

Aesthet Surg J. 2015 Jul;35(5):589-99. doi: 10.1093/asj/sjv050. Epub 2015 May 11.

Abstract

BACKGROUND

Juvéderm Voluma XC is a volumizing hyaluronic acid filler used for correction of age-related midface volume deficit (MVD).

OBJECTIVES

The effectiveness of Juvéderm Voluma XC was examined from the patient perspective.

METHODS

Patients with moderate to severe age-related MVD (N = 235) received Juvéderm Voluma XC. At quarterly follow-up visits for 2 years, patients rated treatment outcomes on the Global Aesthetic Improvement Scale (GAIS), overall satisfaction with facial appearance, satisfaction with midfacial regions, achievement of treatment goal, Look and Feel of the Midface (LAFM), and Self-Perception of Age (SPA). Patients recorded treatment-site responses in 30-day diaries.

RESULTS

At 6 months and 2 years after treatment, 92.8% and 79.0% of patients, respectively, rated their cheek volume as improved/much improved on the GAIS. Improvement in satisfaction with facial appearance was noted by 89.8% of patients at 6 months and 75.8% at 2 years. Increased satisfaction with outer and lower cheek areas and cheek-bone projection and clinically significant improvements in LAFM were noted through month 24. Treatment goals were achieved by 67.8% of patients at 6 months and 49.0% at 2 years. Patients reported looking, on average, 5 years younger at 6 months and 3 years younger at 2 years. The most common treatment site responses were tenderness, swelling, firmness, and lumps/bumps; most were mild to moderate in severity and lasted ≤2 weeks.

CONCLUSIONS

Juvéderm Voluma XC for age-related MVD is effective and well-tolerated from the patient perspective, with results lasting up to 2 years.

LEVEL OF EVIDENCE

4 Therapeutic.

摘要

背景

乔雅登极致丰颜XC是一种用于矫正与年龄相关的中面部容量缺失(MVD)的填充用透明质酸。

目的

从患者角度检验乔雅登极致丰颜XC的有效性。

方法

患有中度至重度与年龄相关MVD的患者(N = 235)接受乔雅登极致丰颜XC治疗。在为期2年的季度随访中,患者根据全球美学改善量表(GAIS)、对面部外观的总体满意度、对中面部区域的满意度、治疗目标的达成情况、中面部的外观和触感(LAFM)以及年龄自我认知(SPA)对治疗效果进行评分。患者在30天的日记中记录治疗部位的反应。

结果

治疗后6个月和2年时,分别有92.8%和79.0%的患者在GAIS上对其脸颊容量评价为改善/显著改善。89.8%的患者在6个月时、75.8%的患者在2年时对面部外观的满意度有所提高。到第24个月时,患者对外侧和下脸颊区域以及颧骨突出的满意度增加,且LAFM有临床显著改善。6个月时67.8%的患者、2年时49.0%的患者达成治疗目标。患者报告称,平均而言,6个月时看起来年轻5岁,2年时年轻3岁。最常见的治疗部位反应为压痛、肿胀、硬结和肿块/凸起;大多数严重程度为轻度至中度,持续时间≤2周。

结论

从患者角度来看,乔雅登极致丰颜XC用于治疗与年龄相关的MVD有效且耐受性良好,效果可持续长达2年。

证据水平

4级治疗性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/57f3/4482214/aa4dd786c181/sjv05001.jpg

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