国产聚焦超声融脂的临床平行对照研究

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1、国产聚焦超声融脂的临床平行对照研究国产聚焦超声融脂的临床平行对照研究［摘耍］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

2、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)o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、紫瘢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。［关键词］聚焦超声；融脂；非侵入性；塑形［中图分类号:R622［文献标识码］A［文章编号11008-6455(2012)02-0190-03Parallelco

3、ntrolledclinicalstudybydomesticnon-invasivefocusedultrasoundDONGYong,LIWen-zhi,JINYen(DepartmentofPlasticSurgeryandLaserMedicine,BeijingAnzhenHospitalofCapitalMedicalUniversityBeijingInstituteofCardiopu1monaryandVascularDisease,Beijing100029,China)Abstract:ObjectiveToobservetheexactcl

4、inicaleffectoffatreductiontreatedbyadomesticnon-invasivefocusedultrasound・MethodsApprovedbytheEthicsCommittee,theunwantedfatonabdomenof40subjectsweretreatedbyanJCS-01non-invasivefocusedultrasounddevice[Beijing311MedicalTechnologyCo.,Ltd],thesubjectsweredividedinto2groupsbyarandom,sing

5、le-blind,negativecontrolmethodinthesametherapeuticschedule,theexperimentalgroupswerecuredwithlaunchedultrasonicenergyandthecontrolgroupswerenot.Thesecaseswerecuredbythissystemwiththeultrasonicfrequency1.9MIIz,theaveragesoundpower(550±20%)W.Thesubjectswerelyinginbedwhencured,thebedoftr

6、eatmentremovedaccordingtotheprocedure,thetransducersinthedevicewasfixedandscannon-interlacedwithintheplanningtherapeuticranges・Treatmentinsubjectswerecured3timeseachonabdomenbynon-invasivefocusedultrasoundandintervalof3days・Thefollowupweremadeafterfourweeksoflasttime・ResultsWiththecom

7、parableweightmeasureofthecontrolandexperimentalgroupswasinbalancedstate(P>0.05),theexperimentalgroupsreducedabdominalcircumferencevalue(3.48±1.12)cm,abdominalcircumferencedecreasedvalueofthecontrolgroups(0.65±0.64)cm,betweenthetwogroupswasstatisticallysignificant(P<0.05).Treatmentin2s

8、ubjec