临床应用聚焦超声减脂塑形治疗的有效性研究

To study the effectiveness of fat reduction treated by non-invasive focused ultrasound

目的探讨临床应用聚焦超声减脂塑形治疗的有效性。方法采用随机、双盲、阴性平行对照的临床试验方法，应用聚焦超声减脂塑形机，对40例自愿受试者的腹部脂肪堆积部位进行减脂治疗。治疗于受试者入组的第1、7天进行，每次对治疗部位进行3次聚焦超声的扫描。随访时间为试验的第1、7天治疗后即刻以及试验的第14、35天，测量指标包括腹围及影像资料等。结果36例受试者完成了聚焦超声减脂塑形2次（6遍）的局部治疗及随访。试验组受试者2次治疗后腹围分别减少了（1．03±0．38）cm、（0．65±0．53）cm，第14、35天随访腹围较治疗前分别减少了（2．52±1．04）cm、（3．31±0．67）cm，与对照组相比，差异有统计学意义（P〈0．05）。结论研究证明，聚焦超声减脂塑形治疗有效。

Objective To explore the effectiveness of fat reduction treated by non-invasive focused ultra- sound. Methods A randomized double-blind negative control clinical trial was carried out on the excess fat of 40 volunteers＂ abdomen by a JCS-01 non-invasive focused ultrasound device. Treatments were performed by the device at 1st and 7th day. During each treatment, 3 times scan by non-invasive focused ultrasound were fin- ished. Data including abdominal girth and imaging materials about the follow-up were recorded at 1st and 7th day postoperatively at once, and 14th and 35th day. Results Totally 36 volunteers accomplished 2 times of treatments and all follow-up. Abdomen circumference of volunteers in the test group decreased of （1.03 ± 0.38） cm, （0.65 ± 0.53） cm in twice treatments, respectively. The data at 14th and 35th day follow-up showed that volunteers＇abdomen circumference in the test group decreased of （2.52± 1.04） cm and （3.31 ±0.67） cm. There were significant differences between the test group and the control group in statistics. Conclusion This clinical research demonstrate that focused ultrasound is effective for body recontouring.