高精度国产复旦数字医疗Excelim-04^(TM)神经导航系统的临床试验

Clinical trial of domestic Fudan digi-medical Excelim-04TM surgery navigation system

目的评价Fudan digi-medical(FDM-excelim-04手术导航系统的临床疗效。方法将60例病人随机分为试验组(使用国产复旦数字医疗excelim-04手术导航系统)与对照组(StealthStationTM神经导航系统),采用MRI影像导航比较其临床效果。试验组设定10个病例采用CT影像导航,与同组的30例MRI影像导航病例互为对照研究,以评价CT影像导航的有效性。结果试验组的临床疗效与对照组达到相同水平,其综合效益指标也与对照组相当。另设CT影像导航的注册误差和定位误差与MRI影像导航相当。结论国产FDM-ex-celim-04手术导航系统已具备了各项临床神经导航外科手术的基本功能,临床疗效良好,可以作为同类国外进口设备的替代产品。

Purpose To evaluate domestic Fudan tion System＇s precision and feasibility. Methods digi-medical （FDM） Excelim-04^TM Surgery NavigaSixty patients with brain tumors were randomly divided into trial group （Excelim-04^TM Surgery Navigation System） and control group （StealthStationTM neuronavigation system） evenly. All patients had routine navigation MR images. A prespective random and matched controlled study was carried out to compare the clinical outcome between the two groups. Another 10 cases used CT images, compared with the cases using MR images （Excelim-04^TM Surgery Navigation System）, in order to assess the efficacy. Results The clinical outcome and general benefit of the trial group were equal to the control group. The mean registration error （2. 18 ± 0.25）mm and system error （1.49 ± 0.33）mm of 10 cases navigatied by CT images were equal to those using MRI images. Conclusions FDM Excelim-04^TM Surgery Navigation System showed high precision and stability and can satisfy clinical requirements of navigation with CT or MRI images.