评估一种新型高强度聚焦超声设备用于消融皮下脂肪组织以进行无创身体塑形的安全性：人体志愿者的安全性研究。

Evaluation of a novel high-intensity focused ultrasound device for ablating subcutaneous adipose tissue for noninvasive body contouring: safety studies in human volunteers.

机构信息

Hospital Torre Médica, México.

出版信息

Aesthet Surg J. 2011 May;31(4):401-10. doi: 10.1177/1090820X11405027.

DOI:10.1177/1090820X11405027

PMID:21551431

Abstract

BACKGROUND

High-intensity focused ultrasound (HIFU) is an energy-based medical technology with many clinical applications. A device under clinical investigation in the United States (LipoSonix; Medicis Technologies Corporation, Bothell, Washington) uses HIFU to reduce localized deposits of abdominal adipose tissue.

OBJECTIVES

The authors describe the results from their clinical trial investigating the safety of this HIFU device in human patients.

METHODS

Over the course of three studies evaluating the safety of the HIFU device for ablating human subcutaneous adipose tissue (SAT), 152 healthy patients were treated with total HIFU energy doses of 47 to 331 J/cm(2)), including patients who presented for elective abdominoplasty and underwent treatment to areas identified for subsequent excision. The safety of each treatment regimen was confirmed before the energy levels were raised. Abdominoplasty was performed up to 14 weeks following the HIFU procedure, and a pathologist performed histopathological analyses of excised tissues. Safety evaluations included an assessment of clinical chemistry and hematology profiles, physical examinations, and adverse events.

RESULTS

Posttreatment ultrasound confirmed that the HIFU effects were limited to targeted SAT layers. Histopathology revealed well-demarcated disruption of adipocytes within the targeted SAT. Phagocytosis of released lipids and cellular debris occurred after 14 to 28 days. Phagocytized lipids underwent normal hepatic metabolism. Healing progressed normally and was 95% complete after eight to 14 weeks. Adverse events consisted primarily of temporary treatment discomfort, edema, erythema, dysesthesia, and ecchymosis. There were no changes in clinical laboratory parameters, and no serious device-related adverse events occurred. Optimal clinical outcomes were achieved with lower energy levels, which provided beneficial effects with the least amount of discomfort.

CONCLUSIONS

HIFU appears to provide a safe means for removing and remodeling unwanted deposits of abdominal SAT.

摘要

背景

高强度聚焦超声（HIFU）是一种基于能量的医疗技术，具有许多临床应用。美国正在临床研究的一种设备（LipoSonix；Medicis Technologies Corporation，华盛顿州 Bothell）使用 HIFU 来减少腹部脂肪组织的局部沉积。

目的

作者描述了他们在人体患者中研究该 HIFU 设备安全性的临床试验结果。

方法

在三项评估 HIFU 设备消融人体皮下脂肪组织（SAT）安全性的研究中，152 名健康患者接受了 47 至 331 J/cm²的总 HIFU 能量剂量治疗，包括因择期腹部整形术就诊并接受治疗的患者，以及治疗为后续切除确定的区域。在提高能量水平之前，确认了每种治疗方案的安全性。HIFU 手术后 14 周进行腹部整形术，病理学家对切除的组织进行组织病理学分析。安全性评估包括评估临床化学和血液学谱、体检和不良事件。

结果

治疗后超声证实 HIFU 效应仅限于靶向 SAT 层。组织病理学显示靶向 SAT 内的脂肪细胞界限分明。吞噬释放的脂质和细胞碎片发生在 14 至 28 天后。吞噬的脂质经历了正常的肝脏代谢。愈合正常进行，8 至 14 周后 95%完全愈合。不良事件主要为暂时性治疗不适、水肿、红斑、感觉异常和瘀斑。临床实验室参数无变化，无严重与设备相关的不良事件发生。较低的能量水平可获得最佳的临床效果，同时提供最少量的不适和最大的益处。