Objective: To evaluate the effectiveness and quality of ultrasound-based (BUS) process optimization in breast cancer screening. Methods: The program collected the first to fourth quarterly breast cancer screening statistic data and case report data from 30 provinces, autonomous regions and municipalities in 2015 by the online report system of national key service program of women and children's public health. The call rate, mammography (MG) subsequent screen rate, biopsy rate, detection rate, early diagnosis rate, carcinoma in situ rate, missing detection rate, false positive rate and positive predictive value (PPV) of breast cancer were calculated. Results: A total of 1 501 753 rural women attended the BUS process optimization screening. The nationwide recall rate was 3.01%(45 156/1 501 753), and in the eastern and central area were 3.41%(17 173/503 130) and 3.56%(14 499/407 739), respectively, higher than 2.28% (13 484/590 884) of western area (P<0.05). The nationwide MG subsequent screen rate was 2.78%(41 694/1 501 753), and in the eastern and central area were 3.19%(16 036/503 130) and 3.29% (13 421/407 739), respectively, higher than 2.07%(12 237/590 884) of western area (P<0.05). The nationwide biopsy rate was 0.23%(3 462/1 501 753), and in the central area were 0.26%(1 078/407 739), respectively, higher than 0.21%(1 247/590 884) of western area and 0.23% (1 137/503 130) of eastern area (P<0.05). The nationwide biopsy PPV was 37.00%(1 281/3 462). The biopsy PPV of eastern area was (34.30%, 390/1 137), lower than 39.33% (424/1 078) of central area (P<0.05). A total of 1 281 cases of breast cancer were detected, the detection rate was 0.85‰(1 281/1 501 753), and the detection rates of central area was 1.04‰ (424/407 739), higher than 0.79‰(467/590 884) of western area and 0.78‰(390/503 130) of eastern area (P<0.05). The BUS initiate screening positive rate from detected breast cancer cases was 96.96%(1 242/1 281), the MG subsequent screening positive rate was 2.42%(31/1 281). The nationwide early diagnosis rate was 85.25%(1 092/1 281), and in the eastern and central areas were 87.95%(343/390) and 88.21%(374/424), higher than 80.30%(375/467) of western area (P<0.05). The screening rate of on or above stage Ⅱ breast cancer in eastern area was 55.64%(217/390), lower than 64.62%(374/424) of central area and 62.31%(291/467) of western area. The missing detection rate was 0.62%(8/1 281) and false positive rate was 1.20%(17 528/1 464 149). Conclusions: The BUS process optimization of breast cancer screening scheme is reasonable and applicable to China rural women. The effectiveness and quality of eastern area are superior to those of central and western area.
目的： 分析评估中国农村基于乳腺超声(BUS)优化流程的乳腺癌筛查效果和质量。 方法： 采用国家妇幼重大公共卫生服务项目信息直报系统中2015年1～4季度全国30个省、自治区、直辖市上报的乳腺癌筛查季度统计表和个案报表的数据，计算中国各地区乳腺癌筛查的召回率、乳腺X线检查(MG)复筛率、活检率、检出率、早诊率、原位癌比例、漏检率、假阳性率和阳性预测值等主要指标。 结果： 2015年共1 501 753人完成农村基于超声优化流程的乳腺癌筛查，全国召回率为3.01%(45 156/1 501 753)；东部和中部地区分别为3.41%(17 173/503 130)和3.56%(14 499/407 739)，高于西部地区(2.28%，13 484/590 884)，差异均有统计学意义(均P<0.05)。全国MG复筛率为2.78%(41 694/1 501 753)；东部和中部地区分别为3.19%(16 036/503 130)和3.29%(13 421/407 739)，高于西部地区(2.07%，12 237/590 884)，差异均有统计学意义(均P<0.05)。全国活检率为0.23%(3 462/1 501 753)；中部地区为0.26%(1 078/407 739)，高于西部地区(0.21%，1 247/590 884)和东部地区0.23%(1 137/503 130)，差异均有统计学意义(均P<0.05)。全国活检阳性率(PPV)为37.00%(1 281/3 462)；东部地区PPV为34.30%(390/1 137)，低于中部地区(39.33%，424/1 078)，差异有统计学意义(P<0.05)。共检出乳腺癌1 281例，检出率为0.85‰(1 281/1 501 753)；中部地区检出率为1.04‰(424/407 739)，高于西部和东部地区[分别为0.79‰(467/590 884)和0.78‰(390/503 130)]，差异均有统计学意义(均P<0.05)。检出乳腺癌人群中，BUS初筛PPV为96.96%(1 242/1 281)，MG复筛PPV为2.42%(31/1 281)。全国乳腺癌早诊率为85.25%(1 092/1 281)；东部和中部地区分别为87.95%(343/390)和88.21%(374/424)，高于西部地区(80.30%，375/467)，差异均有统计学意义(均P<0.05)；东部地区筛查出Ⅱ期及以上乳腺癌比例(55.64%，217/390)低于中部和西部地区[分别为64.62%(274/424)和62.31%(291/467)]，差异均有统计学意义(均P<0.05)。筛查漏检率为0.62%(8/1 281)，假阳性率为1.20%(17 528/1 464 149)。 结论： 基于BUS优化流程的乳腺癌筛查具有可行性和合理性，东部地区筛查的效果和质量优于中部和西部地区。.
Keywords: Assessment; Breast neoplasms; Breast ultrasound screening; Data analysis; Rural women.