Department of Plastic Surgery, Assaf Harofeh Medical Center, Zerifin, affiliated with the Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
Dermatol Surg. 2013 May;39(5):744-51. doi: 10.1111/dsu.12123. Epub 2013 Feb 22.
High-intensity focused ultrasound (HIFU) lipolysis is a noninvasive alternative to existing surgical body-sculpting methods.
To evaluate the safety, tolerability, and histologic outcome of HIFU lipolysis using a novel device in human subjects.
In a single-blind pilot study, six healthy subjects scheduled to undergo abdominoplasty within 4 weeks received HIFU lipolysis on one side of the umbilicus. An identical placebo treatment was given to the contralateral side. Patient evaluation of complications, blood tests, and urine analysis were performed 1, 3, 7, 14, and 28 days after treatment. Excised tissue from the treated areas was sent for histologic review.
Treatment was well tolerated. Average visual analogue pain scale scores were 3.5 ± 2.3 (range 1-7) and 0.17 ± 0.41 (range 0-1). No major adverse events were documented, and laboratory analysis after HIFU lipolysis was normal. Fat necrosis with infiltration of lymphocytes and macrophages without adjacent tissue damage was documented on histology 2 to 4 weeks after HIFU lipolysis. Damage extent correlated with size of the area treated. No pathologic findings were found on the control side.
High-intensity focused ultrasound treatment was well tolerated and safe. Focal damage to target tissue was documented, with adjacent tissues remaining intact.
高强度聚焦超声（HIFU）脂肪溶解术是一种替代现有外科身体塑形方法的非侵入性方法。
使用新型设备评估高强度聚焦超声脂肪溶解术在人体中的安全性、耐受性和组织学结果。
在一项单盲先导研究中，六名计划在 4 周内接受腹部整形术的健康受试者在脐部一侧接受 HIFU 脂肪溶解术。对另一侧进行相同的安慰剂治疗。在治疗后 1、3、7、14 和 28 天，对患者进行并发症评估、血液检查和尿液分析。从治疗区域切除的组织被送去进行组织学检查。
治疗耐受良好。平均视觉模拟疼痛评分分别为 3.5 ± 2.3（范围 1-7）和 0.17 ± 0.41（范围 0-1）。未记录到重大不良事件，HIFU 脂肪溶解术后的实验室分析正常。HIFU 脂肪溶解后 2 至 4 周，在组织学上观察到脂肪坏死伴淋巴细胞和巨噬细胞浸润，而无相邻组织损伤。损伤程度与治疗区域的大小相关。在对照侧未发现病理发现。
高强度聚焦超声治疗耐受良好且安全。目标组织的局灶性损伤得到证实，相邻组织保持完整。
