国产聚焦超声融脂的临床平行对照研究

目的:研究国产聚焦超声融脂设备临床应用的确切疗效。方法:经伦理委员会批准,应用北京汇福康医疗技术有限公司生产的JCS-01型聚焦超声减脂塑形机,以超声波频率1.9MHz、平均声功率(550±20%)W、在相同治疗方案指导下,采用随机、单盲、阴性对照方法将受试者平均分为2组,实验组发射超声能量,对照组不发射能量,对40例志愿受试者的腹部脂肪堆积部位进行减脂塑形治疗。治疗时受试者仰卧在治疗床上,设备治疗头固定,治疗床按程序自行移动,在设定治疗范围内逐行扫描。每位受试者治疗一次,聚焦超声在腹部扫描3遍,3天后再重复治疗一次,4周后随访。结果:对照、实验两组受试者体重在测量指标均衡可比(P>0.05)的状态下,实验组腹围减少值为(3.48±1.12)cm,对照组腹围减少值为(0.65±0.64)cm,两组间对比具有统计学意义(P<0.05)。治疗过程中有2名受试者出现轻微疼痛和热感,涂抹耦合剂后即刻消失,未见红肿、红斑、紫癜和水疱等不良反应出现。结论:应用聚焦超声进行减脂塑形治疗,临床证明安全有效。

Parallel controlled clinical study by domestic non-invasive focused ultrasound

Objective To observe the exact clinical effect of fat reduction treated by a domestic non-invasive focused ultrasound.Methods Approved by the Ethics Committee,the unwanted fat on abdomen of 40 subjects were treated by an JCS-01 non-invasive focused ultrasound device Beijing 3H Medical Technology Co.,Ltd],the subjects were divided into 2 groups by a random,single-blind,negative control method in the same therapeutic schedule,the experimental groups were cured with launched ultrasonic energy and the control groups were not.These cases were cured by this system with the ultrasonic frequency 1.9MHz,the average sound power(550±20%)W.The subjects were lying in bed when cured,the bed of treatment removed according to the procedure,the transducers in the device was fixed and scan non-interlaced within the planning therapeutic ranges.Treatment in subjects were cured 3 times each on abdomen by non-invasive focused ultrasound and interval of 3 days.The follow-up were made after four weeks of last time.Results With the comparable weight measure of the control and experimental groups was in balanced state(P>0.05),the experimental groups reduced abdominal circumference value(3.48±1.12) cm,abdominal circumference decreased value of the control groups(0.65±0.64) cm,between the two groups was statistically significant(P<0.05).Treatment in 2 subjects with a minor sense of pain and heat,applied immediately after the disappearance of coupling agent,no swelling,erythema,purpura,and blisters and other adverse reactions occurred.Conclusion This clinical observation shows the efficacy and safety of focused ultrasound machine for body contouring.