目的在对具有乳腺癌高发风险的人群筛查中,比较立体数字化钼靶成像(DM)与标准DM对癌症的检出率和病人召回率的差异。材料与方法于2004年9月—2007年12月进行的本项前瞻性研究符合HIPAA法案,筛查实验经过伦理委员会的同意,所有参加该试验的具有乳腺癌高发风险的女性病人(如有乳腺癌病史或直系亲属有乳腺癌)均签订知情同意书。获得共779例病人(年龄32～91岁,平均58.6岁)的1298次检查可供分析的数据集。采用配对研究设计,每例参与本实验的病人均为自身进行对照。在一次检查中病人接受立体DM与标准DM检查,所获得的影像学表现由2名有经验的放射科医生独立进行判读,使用乳腺成像报告与数据系统(BI-RADS)进行评估(分为0、1、2级)。对所有病人的一个或更多的确定的形态学发现都进行召回性的规范诊断评价。针对这些结果都进行1年以上的随访观察或活检来确定病例的真实性。结果与DM比较,立体DM对癌症的检测具有更高的特异度[91.2%(共1167/1279次检查出现异常)∶87.8%(共1123/1279次检查出现异常);P=0.0024]和准确度[90.9%(共准确诊断1180/1298次)∶87.4%(共准确诊断1135/1298次);P=0.0023]。在癌症检测的敏感度方面,立体DM(68.4%,13/19例)与标准DM(63.2%,12/19例)的差异无统计学意义(P>0.99)。在病人的召回率方面,立体DM为9.6%(1298例病人中召回125例),DM为12.9%(1298例病人中召回168例)(P=0.0018)。结论与DM比较,立体DM可以显著提高癌症检测的特异性,并且可以保持比较高的敏感性。立体DM与DM相比,可以显著降低病人的召回率。 OBJECTIVE: To compare the detection rate of cancer and the patient recall rate between stereoscopic digital mammography (DM) and standard DM in the screening of people at high risk of breast cancer. MATERIALS AND METHODS This prospective study, conducted from September 2004 to December 2007, was in accordance with the HIPAA Act. All screening trials, with the consent of the ethics committee, all women with breast cancer risk who participated in the trial, Cancer history or immediate family members have breast cancer) have signed informed consent. A total of 1298 data sets for analysis of 779 patients (aged 32-91 years, mean 58.6 years) were obtained. Using a paired study design, each patient involved in this experiment was self-controlled. The patients underwent a stereoscopic DM and a standard DM test in one examination. The imaging findings obtained were independently interpreted by two experienced radiologists and evaluated using the Breast Imaging Reporting and Data System (BI-RADS) (divided into 0 , Level 1,2). Recall that a standardized diagnostic evaluation of one or more confirmed morphologic findings was made for all patients. All these results were followed up for more than 1 year or biopsy to determine the authenticity of the case. Results Stereoscopic DM had a higher specificity for the detection of cancer compared with DM [91.2% (1167/1279 examinations in total): 87.8% (1123/1279 examinations in total); P = 0.0024] and accurate Degree [90.9% (1180/1298 correct diagnosis): 87.4% (1135/1298 correct diagnosis); P = 0.0023]. There was no significant difference in the sensitivity of cancer detection between DM (68.4%, 13/19) and standard DM (63.2%, 12/19) (P> 0.99). In terms of patient recall, Stereoscopic DM was 9.6% (125 of 1,298 patients were recalled) and DM was 12.9% (168 of 1,298 patients were recalled) (P = 0.0018). Conclusion Compared with DM, stereotactic DM can significantly improve the specificity of cancer detection, and can maintain a relatively high sensitivity. Stereoscopic DM compared with DM, can significantly reduce the patient’s recall rate.