Cao Hairu, Long Xiao, Zhang Han, Xu Lin, Liu Zhifei, Wang Xiaojun
Plastic and aesthetic surgery center, Peking Union Medical College Hospital, Beijing,100032.
Zhongguo Yi Liao Qi Xie Za Zhi. 2012 Sep;36(5):370-2, 381.
To evaluate the safety and efficacy of using the JCS-01 focused ultrasound fat reduction machine for noninvasively breaking fat cells and abdomen sculpting treatment.
40 qualified subjects were enrolled in the study per the IRB-approved protocol and randomly assigned into trial and control groups. The fat reduction treatments were performed using the JCS-01 focused ultrasound fat reduction machine made by Beijing 3H Medical Technology Co., Ltd. The trial group received ultrasound energy treatment in their abdominal subcutaneous adipose tissue on the 1st and 7th days of the trial. The control group followed the similar procedure except that the ultrasound energy was turned off during treatments. Both the trial and control groups were followed-up on 1,7,14, 35 days post treatment.
The waist circumference measured on 14, 35 days were reduced 2.52 cm +/- 1.04 cm and 3.31 cm +/- 0.67cm in comparison with the baseline values in the trial group, reaching the protocol hypothesis of at least 1.5 cm abdominal circumference reduction, which demonstrated the treatment efficacy. The adverse events included minor and transient thermal sensation and mild pain in the treated abdomen area in the trial group. No other adverse events were observed. Clinical biochemistry assay testing showed that the subjects liver and kidney function indicators had no significant change.
It is safe and effective to use the JCS-01 focused ultrasound fat reduction machine for abdomen fat reduction treatment.
评估使用JCS - 01聚焦超声减脂机无创破坏脂肪细胞及腹部塑形治疗的安全性和有效性。
按照经机构审查委员会（IRB）批准的方案，40名符合条件的受试者被纳入研究，并随机分为试验组和对照组。使用北京3H医疗科技有限公司生产的JCS - 01聚焦超声减脂机进行减脂治疗。试验组在试验的第1天和第7天对其腹部皮下脂肪组织进行超声能量治疗。对照组遵循相同程序，只是在治疗期间关闭超声能量。试验组和对照组在治疗后1、7、14、35天进行随访。
试验组在治疗后14天和35天测量的腰围与基线值相比分别减少了2.52 cm±1.04 cm和3.31 cm±0.67 cm，达到了方案假设的至少减少腹围1.5 cm，证明了治疗效果。不良事件包括试验组治疗腹部区域出现轻微短暂的热感和轻度疼痛。未观察到其他不良事件。临床生化检测显示受试者的肝肾功能指标无显著变化。
使用JCS - 01聚焦超声减脂机进行腹部减脂治疗是安全有效的。
