Wilkerson Eric C, Bloom Bradley S, Goldberg David J
Skin Laser & Surgery Specialists of NY and NJ, New York, NY, USA.
J Cosmet Dermatol. 2018 Apr;17(2):157-161. doi: 10.1111/jocd.12480. Epub 2018 Jan 22.
An FDA-cleared focused ultrasound device (UltraShape, Syneron Candela , Yokneam, Israel) for noninvasive abdominal fat reduction produces localized mechanical cellular membrane disruption in adipocytes. This study seeks to determine the safety and efficacy of this device for use on the thighs.
STUDY DESIGNS/MATERIALS AND METHODS: Fourteen women aged 33-60 were selected to receive 3 biweekly treatments to one thigh with the other thigh serving as an internal control. The subjects had a BMI range of 18-30 kg/m and a weight range of 54-83 kg. After the third treatment, patients were followed at 4, 8, and 16 weeks. Fat thickness was measured by both caliper and ultrasound. In addition, thigh circumference and the patient's weight were measured. Pain, edema, erythema, and adverse events as well as investigator and patient overall satisfaction were recorded at all visits.
In comparison with the control, there was a statistically significant average reduction in fat thickness measured by calipers at all time points with a 22.20% (P = .0165) improvement in 16 weeks. By ultrasound, there was a 19.23% (4.03 mm P = .0051) reduction in fat thickness at 16 weeks with statistically significant improvement at the other follow-up visits. At 16 weeks, thigh circumference improved, on average, 2.8 cm (P = .0059) at the midline. 90.0% of the subjects were satisfied with the results at 16 weeks, and the investigator was 100% satisfied. No adverse events were reported; no edema was observed in any subject. All subjects experienced mild erythema. All reported zero pain on a 0-10 scale.
Focused ultrasound is safe, effective, and well tolerated to improve the circumference and fat thickness of the thighs without significant side effects. There were no significant adverse events. Investigators and subjects were highly satisfied with the results.
一种获得美国食品药品监督管理局（FDA）批准的用于无创腹部减脂的聚焦超声设备（UltraShape，赛诺龙科医人公司，以色列约克奈姆）可在脂肪细胞中产生局部机械性细胞膜破坏。本研究旨在确定该设备用于大腿的安全性和有效性。
研究设计/材料与方法：选择14名年龄在33至60岁之间的女性，对一侧大腿每两周进行3次治疗，另一侧大腿作为内部对照。受试者的体重指数（BMI）范围为18至30kg/m²，体重范围为54至83kg。第三次治疗后，在第4、8和16周对患者进行随访。通过卡尺和超声测量脂肪厚度。此外，测量大腿周长和患者体重。在所有就诊时记录疼痛、水肿、红斑和不良事件以及研究者和患者的总体满意度。
与对照组相比，在所有时间点通过卡尺测量的脂肪厚度平均有统计学意义的降低，16周时改善了22.20%（P = 0.0165）。通过超声测量，16周时脂肪厚度降低了19.23%（4.03mm，P = 0.0051），在其他随访就诊时有统计学意义的改善。在16周时，大腿中部周长平均改善了2.8cm（P = 0.0059）。90.0%的受试者对16周时的结果满意，研究者的满意度为100%。未报告不良事件；未在任何受试者中观察到水肿。所有受试者均出现轻度红斑。所有受试者在0至10分的疼痛评分中均报告为零疼痛。
聚焦超声安全、有效且耐受性良好，可改善大腿周长和脂肪厚度，且无明显副作用。未出现重大不良事件。研究者和受试者对结果高度满意。
