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不同品牌的X射线引导下乳腺活检立体定位穿刺装置的临床性能对比

Comparison of the Clinical Performance of Different Brands of X-ray Guided Stereotactic Breast Biopsy Device
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摘要 目的评价不同品牌的X射线引导下的乳腺活检立体定位穿刺装置的临床性能。方法以品牌U、品牌S和品牌H为评价对象,利用穿刺模体和2种穿刺针(勾丝定位针和核芯针)对定位准确性进行测试,评价立体定位装置的定位准确性。利用聚甲基丙烯酸甲酯模体对平均腺体剂量(Average Gland Dose,AGD)进行测试,计算AGD总和,并据此评价立体定位装置的辐射剂量。利用CIRS013穿刺模体对操作工作流进行测试,以此评价立体定位装置的操作流程。结果在定位准确性方面,品牌U、品牌S和品牌H比较差异无统计学意义(P>0.05),定位准确性评价均为非常准确;在辐射剂量方面,品牌H的AGD总和显著高于品牌U和品牌S(P<0.001);在操作工作流程评价方面,品牌U和品牌S的操作步骤大致相同,品牌H的操作步骤较多,操作工作流程较为复杂。结论3款X射线引导下的乳腺活检立体定位穿刺装置均有较高的定位准确性,能满足临床需求。 Objective To evaluate the clinical performance of different brands of X-ray guided stereotactic breast biopsy devices.Methods Three brands of X-ray guided stereotactic breast biopsy device,brand U,brand S and brand H were evaluated.The phatom and two kinds of puncture needles(hook needle and core needle)were used to evaluate the localization accuracy of the stereotactic breast biopsy device.The average gland dose(AGD)of the three devices was tested by PMMA model.The sum of AGD during stereotactic puncture was calculated to evaluate the radiation dose of the breast biopsy device.The CIRS013 phatom was used to test the operation workflow of each brands device.Results There was no significant difference on localization accuracy among brand U,brand S and brand H(P>0.05).The localization accuracy evaluations of all brands were very accurate.In terms of radiation dose,the total AGD of brand H was significantly higher than that of the other two brands(P<0.001).In terms of operation workflow evaluation,the operation steps of brand U and brand S were roughly similar,while the operation steps of brand H were more complicated.Conclusion The three X-ray guided stereotactic breast biopsy devices are all highly accurate in localization and can meet the clinical needs.
作者 谭令 柴丽 朱乃懿 朱宏 柴维敏 TAN Ling;CHAI Li;ZHU Naiyi;ZHU Hong;CHAI Weimin(Department of Radiology,Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine,Shanghai 200025,China)
出处 《中国医疗设备》 2022年第7期26-30,共5页 China Medical Devices
基金 上海市科学技术委员会科研计划项目(18441901600)。
关键词 乳腺活检立体定位穿刺装置 临床性能 定位准确性 辐射剂量 stereotactic breast biopsy device clinical performance localization accuracy radiation dose
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