|摘要||目的 探讨聚焦超声减脂塑形机用于腹部减脂塑形的安全性和有效性.方法 选取40例健康受试者,随机分为实验组和对照组,每组20例,按照单盲法实验原则.采用JCS-01型聚焦超声减脂塑形机对受试者的腹部区域做间隔7d的2次治疗.治疗时,固定治疗探头,操作仪器使治疗床按指定区域自行移动.对照组在治疗时调整器械无能量输出.在两次治疗前及治疗后第14天和第35天进行腹围测量、局部拍照以及安全性随访,第35天实验结束时调查受试者满意度.结果 40例受试者中失访1例,其余39例均未发生皮肤红斑、水肿或丘疹,实验室检查未发现有临床意义变化.在治疗后各时间点,实验组中腹围减少＞0.5 cm的受试者,所占的比例均明显高于对照组(P＜0.05).在第35天时两组的腹围减少差异最为显著,20例实验组的受试者中有19例的腹围减少0.83～6.33 cm,平均减少值约3.09 cm,总有效率为95％,受试者满意率为75％.结论 聚焦超声减脂塑形机具有较高安全性,用于腹部减脂塑形有一定效果.
Objective To evaluate the clinical safety and efficacy of focused ultrasound body contouring apparatus in abdominal fat reduction and body contouring.Methods Forty healthy subjeets were equally randomized into treatment group and control group,and received two treatments with the JCS-01 device (3H Medical Technology Co,Ltd,Beijing,China) in the abdominal region at one-week interval.During each treatment,the subject was placed on the treatment bed and the region of interest was spread with an acoustic coupling medium.Then the ultrasonic transducer was fixed,and the operator controlled the computerized system to move the bed in a designed regon.The control group would not receive any energy therapy during treatment time.Subjects were followed for 28 days after the last treatment (day 35).Abdominal circumference,regional photos and safety parameters were recorded at the time instantly before and after treatment and days 14 and 35.Subject satisfaction survey was conducted at day 35.Results One subject in control group was loss of follow-up.No local skin reactions,such as erythema edema or papules,and no changes with clinical significance in laboratory examinations occurred in all other 39 subjects.The proportion of subjects with over 0.5 cm abdominal circumference reduction in the treatment group was significantly higher than the control group at all time points (P＜0.05).Peak abdominal circumference reduction was on day 35.The abdominal circumferences of 19/20 subjects in the treatment group were reduced by 0.83-6.33 cm,and the mean abdominal circumference was reduced by 3.09 cm on day 35.The total effective rate was 95 ％,and the subject satisfactory rate was 75 ％.Conclusions The focused ultrasound treatments for body contouring is safe and tolerable and also significantly reduces abdominal circumference.|
聂芳菲,赵霞,陈东明,等. 聚焦超声减脂塑形机用于腹部减脂塑形的临床观察[J]. 中华医学美学美容杂志,2012,18(5):357-359.