CAJ | 학술논문

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.
목적 탐토취초초성감지소형궤용우복부감지소형적안전성화유효성.방법 선취40례건강수시자,수궤분위실험조화대조조,매조20례,안조단맹법실험원칙.채용JCS-01형취초초성감지소형궤대수시자적복부구역주간격7d적2차치료.치료시,고정치료탐두,조작의기사치료상안지정구역자행이동.대조조재치료시조정기계무능량수출.재량차치료전급치료후제14천화제35천진행복위측량、국부박조이급안전성수방,제35천실험결속시조사수시자만의도.결과 40례수시자중실방1례,기여39례균미발생피부홍반、수종혹구진,실험실검사미발현유림상의의변화.재치료후각시간점,실험조중복위감소＞0.5 cm적수시자,소점적비례균명현고우대조조(P＜0.05).재제35천시량조적복위감소차이최위현저,20례실험조적수시자중유19례적복위감소0.83～6.33 cm,평균감소치약3.09 cm,총유효솔위95％,수시자만의솔위75％.결론 취초초성감지소형궤구유교고안전성,용우복부감지소형유일정효과.
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.