JCS-01型无创聚焦超声减脂机有效性及安全性研究.pdfVIP

Chinese Journal of Medical Instrumentation 2012 年 36 卷第 5 期 监 管 与 测 试 文章编号 1671-7104(2012)05-0370-03 ： JCS-01型无创聚焦超声减脂机有效性及安全性研究 【作 者】曹海茹，龙笑，张寒，许琳，刘志飞，王晓军 中国医学科学院中国协和医科大学北京协和医院整形外科，北京市，100032 【摘 要】 目的观察JCS-01型聚焦超声减脂机治疗的有效性与安全性。方法 40例受试者随机分为治疗组与对照组,采用北京汇福康 医疗技术有限公司研发生产的JCS-01型聚焦超声减脂机,治疗组于试验的第一天和第七天对腹部皮下脂肪行减脂治疗各1次, 两组随访时间为治疗后第一天、第七天、第十四天和第三十五天。结果 治疗组在开始治疗后第十四天和第三十五天腹围与 基线值比较，分别减少了（2.52 ±1.04）cm和（3.31 ±0.67 ）cm ，达到了实验设计的腹围差值1.5cm的预期效果，疗效 明确。试验组不良事件主要为腹部短暂轻微热感和轻度刺痛，未见其他不良反应。实验室检查结果显示聚焦超声对受试者 肝肾功能没有明显影响。结论应用JCS-01型聚焦超声减脂安全、有效。 【关 键 词】聚焦超声；减脂；腹围；有效性；安全性 R454 【中图分类号】 A doi:10.3969/j.issn.1671-7104.2012.05.016 【文献标志码】 The Efficacy and Safety Study of JCS-01 Non-invasive Focused Ultrasound Fat Reduction Machine 【Writers 】Cao Hairu, Long Xiao, Zhang Han, Xu Lin, Liu Zhifei, Wang Xiaojun * Plastic and aesthetic surgery center , Peking Union Medical College Hospital, Beijing,100032 【Abstract 】Objective 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. Method 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