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单平面与双平面微聚焦超声联合可视化技术治疗上臂皮肤松弛:一项随机、单盲、对照临床试验。

Single-Plane Versus Dual-Plane Microfocused Ultrasound With Visualization in the Treatment of Upper Arm Skin Laxity: A Randomized, Single-Blinded, Controlled Trial.

机构信息

Division of Dermatology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, 10400, Thailand.

出版信息

Lasers Surg Med. 2021 Apr;53(4):476-481. doi: 10.1002/lsm.23307. Epub 2020 Aug 8.

DOI:10.1002/lsm.23307
PMID:32770693
Abstract

BACKGROUND AND OBJECTIVES

Non-invasive skin tightening devices have become a safe and non-invasive treatment for patients with skin laxity of the upper arm. The efficacy of microfocused ultrasound with visualization (MFU-V) in skin tightening had been demonstrated in several studies. This study aimed to evaluate the efficacy and safety of MFU-V in treating skin laxity of the upper arm using different treatment protocols.

STUDY DESIGN/MATERIALS AND METHODS: Thirty patients with upper arm laxity were enrolled. Patients were randomly assigned to receive single-plane MFU-V treatment (4 MHz/4.5 mm transducer) on one arm and dual-plane treatment (4 MHz/4.5 mm and 7 MHz/3.0 mm transducer) on the contralateral arm, totaling 200 lines in each arm. Investigator Assessment Skin Laxity Scoring System (IASLSS) and improvement scores were evaluated at 1, 3, and 6 months after the treatment. Adverse events were recorded.

RESULTS

A modest reduction of mean arm circumference was observed on both sides. Mean physician-rated improvement scores,  single-plane treatment received 2.22 (±1.05), 2.70 (±1.32), and 1.61 (±0.79), respectively. Dual-plane treatment received 2.00 (±1.00), 2.56 (±1.05), and 1.39 (±0.54), respectively. Single-plane treatment was superior from physician's ratings (P < 0.05). IASLSS followed the same trend as the improvement scores. Mean patient-rated improvement scores in single-plane treatment were 3.63 (±2.63), 3.69 (±2.83), 1.90(±2.51) for 1, 3, and 6 months, respectively. Dual-plane treatment received 3.5 (±2.57), 3.22 (±2.59), 1.78 (±2.48), respectively. The median pain scores were 2.6 (0-8) for single-plane treatment and 1.9 (0-8) for dual-plane treatment (P = 0.136). No other significant side effects were observed.

CONCLUSION

Both single-plane and dual-plane treatment provide a modest skin tightening effect in the upper arm for at least 3 months. Physicians should assess skin thickness in every patient using the visualization screen to select the appropriate transducer for each individual patient. Lasers Surg. Med. © 2020 Wiley Periodicals LLC.

摘要

背景与目的

非侵入性皮肤紧致设备已成为治疗上臂皮肤松弛的安全、非侵入性治疗方法。已有多项研究证明微聚焦超声与可视化(MFU-V)在皮肤紧致方面的疗效。本研究旨在评估不同治疗方案中单平面和双平面 MFU-V 治疗上臂皮肤松弛的疗效和安全性。

研究设计/材料和方法:共纳入 30 例上臂皮肤松弛患者。患者随机分为单侧单平面 MFU-V 治疗(4MHz/4.5mm 换能器)组和对侧双平面治疗(4MHz/4.5mm 和 7MHz/3.0mm 换能器)组,每组各 200 条治疗线。在治疗后 1、3 和 6 个月分别采用研究者评估皮肤松弛评分系统(IASLSS)和改善评分进行评估。记录不良反应。

结果

双侧臂周径均有适度减少。单平面治疗组的平均医生评价改善评分分别为 2.22(±1.05)、2.70(±1.32)和 1.61(±0.79)。双平面治疗组分别为 2.00(±1.00)、2.56(±1.05)和 1.39(±0.54)。单平面治疗在医生评价方面更优(P<0.05)。IASLSS 评分与改善评分呈相同趋势。单平面治疗组患者自评改善评分分别为 3.63(±2.63)、3.69(±2.83)和 1.90(±2.51),分别为治疗后 1、3 和 6 个月。双平面治疗组分别为 3.5(±2.57)、3.22(±2.59)和 1.78(±2.48)。单平面治疗的中位数疼痛评分为 2.6(0-8),双平面治疗为 1.9(0-8)(P=0.136)。未观察到其他明显的不良反应。

结论

单平面和双平面治疗均能在至少 3 个月内对上臂皮肤产生适度的紧致效果。医生应在治疗前通过可视化屏幕评估每位患者的皮肤厚度,为每位患者选择合适的换能器。激光外科医学杂志。© 2020 威利父子公司。

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