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评估一种用于改善下脸部皮肤松弛和紧致的微聚焦超声系统。

Evaluation of a microfocused ultrasound system for improving skin laxity and tightening in the lower face.

作者信息

Oni Georgette, Hoxworth Ron, Teotia Sumeet, Brown Spencer, Kenkel Jeffrey M

机构信息

Dr Oni is a research fellow, Drs Hoxworth and Teotia are assistant professors, and Dr Kenkel is a professor and vice-chairman of the Department of Plastic Surgery, University of Texas Southwestern Medical Center, DallasDr Brown is a professor and executive director of the Department of Plastic Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.

Dr Oni is a research fellow, Drs Hoxworth and Teotia are assistant professors, and Dr Kenkel is a professor and vice-chairman of the Department of Plastic Surgery, University of Texas Southwestern Medical Center, DallasDr Brown is a professor and executive director of the Department of Plastic Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania

出版信息

Aesthet Surg J. 2014 Sep;34(7):1099-110. doi: 10.1177/1090820X14541956. Epub 2014 Jul 2.

DOI:10.1177/1090820X14541956
PMID:24990884
Abstract

BACKGROUND

The Ulthera System (Ulthera, Inc, Mesa, Arizona) employs microfocused ultrasound to cause discrete focal heating of the dermis and stimulate neocollagenesis and elastin remodeling.

OBJECTIVES

The authors investigated tightening and lifting of cheek tissue, improvement in jawline definition, and reduction in submental skin laxity in patients treated with the Ulthera System.

METHODS

A total of 103 adults were enrolled in this prospective nonrandomized clinical trial. Three-dimensional photographs obtained at baseline and 3 months posttreatment were assessed qualitatively by 3 blinded reviewers and quantitatively with AutoCAD software (Informer Technologies, Redwood City, California). The relationship between outcomes and body mass index (BMI) was examined as well. Patients rated pain during the procedure and provided subjective assessment of their outcome at 90 days. Adverse events were documented.

RESULTS

Ninety-three patients were evaluated. Blinded reviewers observed improvement in skin laxity in 58.1% of patients. During quantitative assessments, overall improvement in skin laxity was noted in 63.6% of evaluated patients. No change was detected in 54.5% of patients whose BMI exceeded 30 kg/m2 or in 12.2% of patients whose BMI was ≤30 kg/m2. At day 90, 65.6% of patients perceived improvement in the skin laxity of the lower half of their face/neck. The average procedural pain scores for the cheek, submental, and submandibular regions were 5.68, 6.09, and 6.53, respectively. Wheals, which resolved without intervention or long-term sequelae, were reported for 3 patients.

CONCLUSIONS

To the authors' knowledge, this is the largest clinical study of the effectiveness of the Ulthera System for rejuvenation of the lower face. At day 90, improvements were reported by two-thirds of patients and by nearly 60% of blinded reviewers. Outcomes were better in patients with BMI≤30 kg/m2.

LEVEL OF EVIDENCE

摘要

背景

超声刀系统(美国亚利桑那州梅萨市的Ulthera公司)采用微聚焦超声对真皮层进行离散性局部加热,刺激新胶原蛋白生成和弹性蛋白重塑。

目的

作者研究了超声刀系统治疗患者面颊组织的紧致和提升效果、下颌轮廓清晰度的改善情况以及颏下皮肤松弛度的降低情况。

方法

共有103名成年人参与了这项前瞻性非随机临床试验。由3名盲法评审员对基线期和治疗后3个月获得的三维照片进行定性评估,并使用AutoCAD软件(加利福尼亚州红木城的Informer Technologies公司)进行定量评估。同时还研究了治疗效果与体重指数(BMI)之间的关系。患者对治疗过程中的疼痛进行评分,并在90天时对治疗效果进行主观评估。记录不良事件。

结果

对93名患者进行了评估。盲法评审员观察到58.1%的患者皮肤松弛情况有所改善。在定量评估中,63.6%的评估患者皮肤松弛情况总体有所改善。BMI超过30kg/m2的患者中有54.5%以及BMI≤30kg/m2的患者中有12.2%未检测到变化。在90天时,65.6%的患者感觉其面部/颈部下半部分的皮肤松弛情况有所改善。面颊、颏下和下颌下区域的平均治疗疼痛评分分别为5.68、6.09和6.53。有3名患者报告出现了风疹块,未经干预即自行消退,且未留下长期后遗症。

结论

据作者所知,这是关于超声刀系统在下半面部年轻化有效性方面规模最大的临床研究。在90天时,三分之二的患者以及近60%的盲法评审员报告有改善。BMI≤30kg/m2的患者治疗效果更佳。

证据级别

2级。

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