射频加热与高强度聚焦电磁场治疗同时实施：首例假控制随机临床试验。
Radiofrequency Heating and High-Intensity Focused Electromagnetic Treatment Delivered Simultaneously: The First Sham-Controlled Randomized Trial.
机构信息
From private practice; the Juva Skin and Laser Center, and Maryland Dermatology, Laser, Skin, & Vein Institute.
出版信息
Plast Reconstr Surg. 2022 May 1;149(5):893e-900e. doi: 10.1097/PRS.0000000000009030. Epub 2022 Mar 9.
BACKGROUND
Radiofrequency-based and high-intensity focused electromagnetic (HIFEM)-based devices have proved effective and safe for abdominal body shaping. Radiofrequency is known to reduce adipose tissue, whereas HIFEM treatment is effective for muscle definition. The authors investigated the efficacy of a novel device delivering synchronized radiofrequency and HIFEM treatment simultaneously for abdominal toning and fat reduction.
METHODS
Seventy-two patients were enrolled and randomly divided into active (n = 48; age, 45.5 ± 13.0 years) and sham groups (n = 24; age, 44.6 ± 12.3 years). Both groups received three treatments on the abdomen once a week. The intensity in the active group was set to maximum tolerable level; in the sham group, the intensities were set to 5 percent. Ultrasound images were taken before treatment and at 1, 3, and 6 months after treatment to examine changes in subcutaneous fat and rectus abdominis muscle thickness. Digital photographs were taken, and satisfaction and therapy comfort were assessed.
RESULTS
Ultrasound images of the active group at 1 month showed significant (p < 0.05) reduction in adipose tissue thickness by 20.5 percent (4.8 ± 2.6 mm), whereas rectus abdominis muscle thickness increased by 21.5 percent (2.0 ± 0.8 mm). Results at 3 months improved to 28.3 percent (7.6 ± 3.7 mm) and 24.2 percent (2.3 ± 0.9 mm), respectively. Improvements were maintained at 6 months after treatment in the active group, whereas the sham group showed no significant changes. Treatments were found to be comfortable. The active group showed higher satisfaction with outcomes.
CONCLUSION
Active treatment utilizing simultaneous application of radiofrequency and HIFEM therapy resulted in a significant increase in rectus abdominis thickness and subcutaneous fat reduction, exceeding previously published results for separate HIFEM and radiofrequency treatments.
CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.
背景
基于射频和高强度聚焦电磁场（HIFEM）的设备已被证明对腹部塑形有效且安全。射频可减少脂肪组织，而 HIFEM 治疗则可有效塑造肌肉轮廓。作者研究了一种同时提供射频和 HIFEM 同步治疗的新型设备对腹部紧致和减脂的疗效。
方法
共招募 72 名患者，并随机分为主动治疗组（n = 48；年龄 45.5 ± 13.0 岁）和假治疗组（n = 24；年龄 44.6 ± 12.3 岁）。两组均每周在腹部接受三次治疗。主动治疗组的强度设定为最大耐受水平；假治疗组的强度设定为 5%。在治疗前、治疗后 1、3 和 6 个月时，使用超声图像检查皮下脂肪和腹直肌厚度的变化。拍摄数码照片，并评估满意度和治疗舒适度。
结果
主动治疗组在治疗 1 个月时的超声图像显示，脂肪组织厚度显著减少（p < 0.05），减少了 20.5%（4.8 ± 2.6 毫米），而腹直肌厚度增加了 21.5%（2.0 ± 0.8 毫米）。治疗 3 个月时，分别改善至 28.3%（7.6 ± 3.7 毫米）和 24.2%（2.3 ± 0.9 毫米）。在治疗后 6 个月时，主动治疗组的改善仍保持，而假治疗组则没有明显变化。治疗被认为是舒适的。主动治疗组对治疗结果的满意度更高。
结论
利用射频和 HIFEM 联合治疗的主动治疗可显著增加腹直肌厚度和减少皮下脂肪，超过了先前分别进行 HIFEM 和射频治疗的研究结果。
临床问题/证据水平：治疗性，II 级。
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