双能X射线骨密度仪的精确度监测与对比分析  

Precision monitoring and comparative analysis of Lunar Prodigy dual energy X-ray bone densitometer

作　　者：赵紫婷 周蕾蕾[2] 方帅[3] 蒋娥[4] 顾加雨 邹奕轩 蒋红兵[1,6] 夏勋荣 ZHAO Zi-ting;ZHOU Lei-lei;FANG Shuai(Department of Medical Equipment,Nanjing First Hospital,Nanjing Medical University(Nanjing First Hospital),Nanjing 210006,China;不详)

机构地区：[1]南京医科大学附属南京医院(南京市第一医院)医疗设备处,江苏南京210006 [2]南京医科大学附属南京医院(南京市第一医院)医学影像科,江苏南京210006 [3]江苏省计量科学研究院,江苏南京210023 [4]南京医科大学附属南京医院(南京市第一医院)核医学科,江苏南京210006 [5]联影医疗科技有限公司,上海嘉定201807 [6]南京市急救中心,江苏南京210003

出　　处：《中国医学装备》2021年第5期5-8,共4页China Medical Equipment

基　　金：国家重点研发计划(2016YFF0201003)“骨质疏松诊断设备计量溯源及中国人群骨密度数据平台建立研究”;南京市医学科技发展资金“青年工程”人才培养专项经费资助项目(QRX11033)“南京市卫生青年人才培养工程”。

摘　　要：目的:通过分析质量保证(QA)检测报告数据,对两台不同使用年限的双能X射线吸收法(DXA)骨密度仪进行全年纵向质量监测与短期稳定性监测。方法:选择医院两台在用的DXA骨密度仪,并将其定义为DXA_(1)和DXA_(2)。收集并分析DXA_(1)与DXA_(2)于2019年6月至2020年7月的每日QA测试骨密度(BMD)、骨矿物质含量(BMC)和有效投影面积(EPA)数据,使用标准模块均值BMD的变异系数评估两台设备的长期精确度;收集并比较DXA_(1)和DXA_(2)于2019年6-7月与2020年6-7月梅雨季连续25 d的QA测试数据,用标准模块均值BMD的变异系数评估设备梅雨季的短期精确度。结果:DXA_(1)与DXA_(2)测量标准模块的均值BMD分别为(1.0010.03)g/cm^(2)和(0.9990.03)g/cm^(2),变异系数分别为0.32%和0.31%,两台DXA的QA数据中BMD、BMC和EPA均有显著统计学差异(Z=-6.765,Z=-17.626,Z=-18.458;P<0.01)。2019年梅雨季DXA_(1)与DXA_(2)的BMD变异系数分别为0.29%、0.27%,2020年梅雨季分别为0.32%、0.29%。两台设备两个梅雨季时段的QA数据差异均无显著统计学意义。结论:两台相同型号骨密度仪每日所测厂家自带体模BMD值有差异,但二者的长期精确度与短期精确度结果相近,均符合行业要求,运行稳定性较好。Objective:To monitor annually longitudinal quality and short-term stability of two dual energy X-ray bone densitometers with different service life by retrospective analysis of test report data of daily quality assurance(QA).Methods:Two using dual energy X-ray bone densitometer of hospital which were named respectively as DXA_(1) and DXA_(2) were selected.The daily QA test data of DXA_(1) and DXA_(2) on bone mineral density(BMD),bone mineral content(BMC)and effective projected area(EPA)from June 2019 to July 2020 were collected and analyzed.The long-term precisions of the two equipment were assessed by the coefficient of variation(CV)of the average BMD of the standard module.And the QA test data of each DXA in continuous 25d during the plum rain season from June to July in 2019 and from June to July in 2020 were collected and compared.The short-term precision of the equipment during plum rain season was assessed by the CV of the average BMD of the standard test module.Results:The means of bone density of standard module that was examined by DXA_(1) and DXA_(2) were(1.001±0.03)g/cm^(2) and(0.999±0.03)g/cm^(2),respectively,and the CVs of them were 0.32%and 0.31%.And in the QA data of two DXA equipment,the differences of BMD,BMC and EPA between the two DXAs were significant(Z=-6.765,Z=-17.626,Z=-18.458,P<0.01).The bone density CVs of DXA_(1) and DX2 were 0.29%and 0.27%during the plum rain season of 2019 year,respectively,and those were 0.32%and 0.29%during the plum rain season of 2020 year.The differences of QA data of two equipment between two plum rain seasons were no significant.Conclusion:There are differences in the daily measured values of bone density of the phantom of manufactures that are measured by two bone densitometers with same type,while the results of long-term precision and short-term precision are similar,which meets the requirement of industry.And the stability of operation is favorable.

关 键 词：双能X射线骨密度仪 精确度 质量保证 对比分析 

分 类 号：R197.39[医药卫生—卫生事业管理]