CAJ | 학술논문

目的探讨临床应用非侵入性聚焦超声减脂塑形机进行塑形治疗的安全性.方法应用JCS01型非侵入性聚焦超声减脂塑形机,对40例自愿受试者进行随机、盲法、阴性平行对照的临床试验.分别间隔6d对受试者腹部脂肪堆积部位进行2次(每次治疗自动扫描3次)治疗,对治疗时的局部反应进行即时观察和随访,并分别于治疗前及第1次治疗后14d进行肝功能及血脂等多项检查.结果 40例受试者中,36例(实验组与对照组各18例)完成了应用非侵入性聚焦超声减脂塑形机减脂塑形治疗的全部临床试验内容,治疗后局部塑形效果明显,试验组4例受试者自述有局部的微热或轻微的刺痛感,1例受试者末次治疗第7天血甘油三酯(三酰甘油)检查结果升高,2周后再复查恢复正常.其他受试者无局部不良反应,各项实验室检查结果无异常.结论在2次间隔6d,每次不超过500 cm2的治疗面积下,临床应用非侵入性聚焦超声减脂塑形机进行塑形治疗是安全的.
목적 탐토림상응용비침입성취초초성감지소형궤진행소형치료적안전성.방법 응용JCS01형비침입성취초초성감지소형궤,대40례자원수시자진행수궤、맹법、음성평행대조적림상시험.분별간격6d대수시자복부지방퇴적부위진행2차(매차치료자동소묘3차)치료,대치료시적국부반응진행즉시관찰화수방,병분별우치료전급제1차치료후14d진행간공능급혈지등다항검사.결과 40례수시자중,36례(실험조여대조조각18례)완성료응용비침입성취초초성감지소형궤감지소형치료적전부림상시험내용,치료후국부소형효과명현,시험조4례수시자자술유국부적미열혹경미적자통감,1례수시자말차치료제7천혈감유삼지(삼선감유)검사결과승고,2주후재복사회복정상.기타수시자무국부불량반응,각항실험실검사결과무이상.결론 재2차간격6d,매차불초과500 cm2적치료면적하,림상응용비침입성취초초성감지소형궤진행소형치료시안전적.
Objective To explore the safety of fat reduction treated by non invasive focused ultrasound.Methods A randomized double-blind and negative control clinical trial was carried out on the excess fat of 40 subjects' abdomen by a JCS-01 non-invasive focused ultrasound device.Subjects received treatments with the device on day 1 and day 7.Observations on the area treated and inquiries on feelings were conducted during treatments.Before the first treatment and 14 days after the treatment,laboratory examinations were performed,including liver function,blood lipid tests,etc.Results 40 subjects participated in the trial and 36 subjects (18 each in both treatment and control groups) accomplished 2 times of treatments,all followed-up and laboratory examinations.During the process of treatments,4 subjects in the experimental group complained about feelings of tepidity or pricking.One subject on blood test of triglyceride showed slightly higher than her early normal result,which fell to the normal level at reexamination.Conclusions Subjects treated by non-invasive focused ultrasound at the area of no more than 500 cm2 every time and at an interval of 6 days manifest little changes on the blood test results,with slightly local reactions but no complaints during follow-up.