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1060nm 半导体激光用于腹部非侵入性脂肪减少的安全性和有效性的临床评估。

Clinical Evaluation of the Safety and Efficacy of a 1060-nm Diode Laser for Non-Invasive Fat Reduction of the Abdomen.

机构信息

Department of General Surgery, MedStar Georgetown University Hospital, Washington, DC, USA.

Department of Plastic Surgery, UT Southwestern Medical Center, Dallas, TX, USA.

出版信息

Aesthet Surg J. 2021 Sep 14;41(10):1155-1165. doi: 10.1093/asj/sjaa418.

Abstract

BACKGROUND

Despite the proven efficacy of liposuction, there is a population of patients who prefer non-surgical alternatives. Laser hyperthermia-induced lipolysis has emerged as one non-invasive alternative to liposuction.

OBJECTIVES

The authors sought to evaluate the safety and efficacy of a 1060-nm (±10 nm) diode laser for non-invasive fat reduction of the abdomen.

METHODS

This single-arm, 2-center study enrolled 30 patients. Patients received a 25-minute 1060-nm diode laser treatment on their abdomen. Ultrasound adipose measurements, body weight, and circumference were taken at baseline and at 6- and 12-week follow-up visits. Blinded evaluators identified "before" and "after" photos of each patient. A patient satisfaction questionnaire was completed by each patient at study exit.

RESULTS

A total 29 patients completed all treatment and follow-up visits. Ultrasound images showed an adipose reduction of 8.55% at 12 weeks post-treatment (P < 0.0001). Blinded evaluators correctly identified 67% of the pre- and post-treatment images at site 01 (Sacramento, CA) and 56% at site 02 (Dallas, TX). Satisfaction was high, with 72% of patients reporting being either "satisfied" or "very satisfied" with their results on a 5-point Likert scale. Pain was rated as mild by 62% of patients, moderate by 38%, and severe by none on the Wong-Baker Scale.

CONCLUSIONS

These results indicate that a single treatment with a 1060-nm (±10 nm) diode laser, per the treatment protocol, is safe and effective in reducing unwanted fat in the abdomen as objectively measured employing ultrasound. The treatment was well-tolerated among all patients, with minimal discomfort reported and high patient satisfaction.

摘要

背景

尽管吸脂术已被证实有效,但仍有一部分患者更喜欢非手术替代方法。激光热疗诱导的脂肪分解已成为吸脂术的一种非侵入性替代方法。

目的

作者旨在评估 1060nm(±10nm)二极管激光用于腹部无创性脂肪减少的安全性和有效性。

方法

这是一项单臂、2 中心研究,共纳入 30 例患者。患者接受 25 分钟 1060nm 二极管激光腹部治疗。在基线和 6 周及 12 周随访时测量超声脂肪测量值、体重和腰围。盲法评估者识别每位患者的“治疗前”和“治疗后”照片。每位患者在研究结束时完成一份患者满意度问卷。

结果

共有 29 例患者完成了所有治疗和随访。超声图像显示治疗后 12 周脂肪减少 8.55%(P<0.0001)。盲法评估者在站点 01(加利福尼亚州萨克拉门托)正确识别了 67%的治疗前和治疗后图像,在站点 02(德克萨斯州达拉斯)正确识别了 56%的图像。患者满意度很高,72%的患者在 5 分制 Likert 量表上报告对治疗结果“满意”或“非常满意”。62%的患者将疼痛评为轻度,38%的患者评为中度,无人评为重度。

结论

这些结果表明,按照治疗方案,单次使用 1060nm(±10nm)二极管激光治疗是安全有效的,可客观地使用超声测量减少腹部多余脂肪。所有患者均能耐受治疗,报告的不适感最小,患者满意度高。

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