Eugene, Ore.; Mountlake Terrace, Wash.; Chapel Hill, N.C.; New Haven, Conn.; Chestnut Hill, Mass.; San Francisco, Calif.; New York, N.Y.; Hunt Valley, Md.; Scottsdale, Ariz.; and Omaha, Neb. From Oregon Health Science University; Cosmetic and Reconstructive Plastic Surgery; Aesthetic Solutions; The Savin Center; Skin Care Physicians; private practice; the Maryland Laser, Skin, and Vein Institute; Medicis Technologies Corporation; and the Advanced Skin Research Center.
Plast Reconstr Surg. 2011 Jul;128(1):253-262. doi: 10.1097/PRS.0b013e3182174278.
High-intensity focused ultrasound presents a noninvasive approach to body sculpting for nonobese patients. The purpose of this study was to evaluate the safety and effectiveness of a high-intensity focused ultrasound device for sculpting of the abdomen and flanks.
Adults (aged 18 to 65 years) with subcutaneous abdominal fat greater than or equal to 2.5 cm thick who met screening criteria were randomized to receive high-intensity focused ultrasound treatment of the anterior abdomen and flanks at energy levels (a total of three passes each) of 47 J/cm (141 J/cm total), 59 J/cm (177 J/cm), or 0 J/cm (no energy applied, sham control). The primary endpoint was change from baseline waist circumference at the iliac crest level at posttreatment week 12. Subjective aesthetic assessments included the Global Aesthetic Improvement Scale and a patient satisfaction questionnaire. Safety assessments included adverse events, laboratory values, and physical examinations.
For the primary endpoint, in the intent-to-treat population, statistical significance versus sham was achieved for the 59-J/cm (-2.44; p = 0.01) but not the 47-J/cm treatment group (-2.06 cm; p = 0.13). In a per-protocol population, statistical significance versus sham was achieved for both the 59-J/cm (-2.52 cm; p = 0.002) and the 47-J/cm treatment groups (-2.10 cm; p = 0.04). Investigator subjective measures of global aesthetic improvement and patient satisfaction also favored each active treatment versus sham. Adverse events included mild to moderate discomfort, bruising, and edema. Laboratory values and physical examinations were unremarkable.
Treatment with this high-intensity focused ultrasound device reduced waist circumference and was generally well tolerated for noninvasive body sculpting. Reduction in waist circumference was statistically significant with both active treatments (per protocol).
CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.(Figure is included in full-text article.).
高强度聚焦超声为非肥胖患者的身体塑形提供了一种非侵入性的方法。本研究的目的是评估高强度聚焦超声设备用于腹部和侧腹塑形的安全性和有效性。
符合筛选标准的皮下腹部脂肪厚度大于或等于 2.5 厘米的成年人被随机分为三组，分别接受高强度聚焦超声治疗前腹部和侧腹部，能量水平分别为 47 J/cm（总 141 J/cm）、59 J/cm（总 177 J/cm）或 0 J/cm（不施加能量，假对照）。主要终点是治疗后 12 周髂嵴水平的腰围变化。主观美学评估包括全球美学改善量表和患者满意度问卷。安全性评估包括不良事件、实验室值和体格检查。
对于主要终点，在意向治疗人群中，与假对照相比，59-J/cm 组（-2.44cm；p=0.01）达到统计学意义，但 47-J/cm 组（-2.06cm；p=0.13）未达到统计学意义。在符合方案人群中，与假对照相比，59-J/cm 组（-2.52cm；p=0.002）和 47-J/cm 组（-2.10cm；p=0.04）均达到统计学意义。研究者对整体美学改善和患者满意度的主观评估也倾向于每种活性治疗方法优于假对照。不良事件包括轻度至中度不适、瘀伤和水肿。实验室值和体格检查无异常。
使用这种高强度聚焦超声设备治疗可减少腰围，且通常对非侵入性身体塑形具有良好的耐受性。两种活性治疗方法（符合方案）均使腰围减少具有统计学意义。
临床问题/证据水平：治疗性，II 级。（全文包含图片。）
