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高强度聚焦超声多能级非侵入式身体塑形的随机、单盲、上市后研究。

A randomized, single-blind, postmarketing study of multiple energy levels of high-intensity focused ultrasound for noninvasive body sculpting.

机构信息

Dermatologic Surgery, University of Toronto, Toronto, Ontario, Canada.

出版信息

Dermatol Surg. 2012 Jan;38(1):58-67. doi: 10.1111/j.1524-4725.2011.02148.x. Epub 2011 Sep 7.

DOI:10.1111/j.1524-4725.2011.02148.x
PMID:22093233
Abstract

BACKGROUND

High-intensity focused ultrasound (HIFU) is a nonsurgical, noninvasive body sculpting method.

OBJECTIVE

To investigate preferences for treatment settings using a HIFU device.

MATERIALS AND METHODS

HIFU was applied to the anterior abdomen in three passes of decreasing depth (1.6, 1.3, and 1.1 cm) in patients randomized to HIFU energy levels (each of 3 passes [total]) of 47 (141), 52 (156), or 59 (177) J/cm(2). The primary assessment was week 12 post-treatment change from baseline waist circumference at the level of the iliac crest for all treatment groups combined.

RESULTS

The primary assessment achieved statistical significance (least squares mean 2.51 cm, 95% confidence interval [CI] = -3.14 to -1.88; p < .001), with no significant differences between groups. At week 12, 69% to 86% of patients and 73% to 79% of investigators rated appearance as improved or much improved. The average worst pain (100-mm visual analog scale) experienced during treatment was mild (47 J/cm(2): 17.1 mm, 95% CI = 4.33-29.81 mm; 52 J/cm(2): 24.6 mm, 95% CI = 12.24-36.95 mm; 59 J/cm(2): 30.9 mm, 95% CI = 18.71-43.17 mm). There were no serious adverse events.

CONCLUSION

HIFU treatment at different energy levels and multiple tissue depths was well tolerated and effective in reducing waist circumference.

摘要

背景

高强度聚焦超声(HIFU)是一种非手术、非侵入性的身体塑形方法。

目的

研究使用 HIFU 设备的治疗环境偏好。

材料和方法

将 HIFU 应用于患者的前腹部,在三个深度逐渐减小的区域(1.6、1.3 和 1.1cm)进行三次处理(每次处理三条路径[总共有 3 次处理]),能量水平分别为 47(141)、52(156)或 59(177)J/cm²。主要评估是所有治疗组联合治疗后 12 周时髂嵴水平的腰围与基线相比的变化。

结果

主要评估达到了统计学意义(最小二乘均数 2.51cm,95%置信区间[CI] = -3.14 至-1.88;p <.001),组间无显著差异。在第 12 周时,69%至 86%的患者和 73%至 79%的研究者认为外观有所改善或明显改善。治疗过程中平均最严重疼痛(100mm 视觉模拟量表)为轻度(47J/cm²:17.1mm,95%CI = 4.33-29.81mm;52J/cm²:24.6mm,95%CI = 12.24-36.95mm;59J/cm²:30.9mm,95%CI = 18.71-43.17mm)。没有严重不良事件。

结论

在不同能量水平和多个组织深度下进行 HIFU 治疗可耐受良好,有效减少腰围。

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