不同钼靶X线阳性标准对乳腺癌筛查成本效果的影响

  目的  根据乳腺癌筛查数据, 比较不同钼靶X线阳性判定标准对其筛查成本效果的影响, 为国家制定乳腺癌筛查方案提供参考。  方法  在2008年7月到2009年9月, 对天津、南昌、肥城和沈阳4个城市开展了一个横断面多中心的乳腺癌筛查研究项目。其中21 986例45~69岁年龄组的妇女进行了乳腺钼靶X线检查, 经过1年随访, 最后65例乳腺癌新发病例被确诊。根据不同钼靶X线检查阳性判定标准计算其各自的灵敏度和特异度。利用马尔科夫模型模拟整个筛查过程, 计算各自的成本效果比值并对其进行敏感性分析。模拟筛查过程时, 对其进行了3%的折扣。成本效果比值用挽救每个生命年所花的费用来表示, 即: ￥/ LYs（life years saved）。  结果  将BIRADS分级0级（需进一步影像检查或与前次影像资料比较才能得出结论）归为阴性, 筛查出55例乳腺癌, 灵敏度为84.6%, 特异度为98.6%, 成本效果比值为45 632￥/LYs; 若0级为阳性, 筛查出56例乳腺癌, 灵敏度为86.2%, 特异度为93.9%, 成本效果比值为52 392￥/LYs。  结论  不同的钼靶X线阳性判定标准对其灵敏度影响较小, 对特异度和成本效果影响较大。 

Effect of Mammography-Positive Criteria on the Cost-Effectiveness of Breast Cancer Screening

  Objective  The current work aims to investigate the effect of mammography-positive criteria on the cost-effectiveness of a breast cancer screening program, and provide a reference for the development of breast cancer screening programs in China.  Methods  From July 2008 to September 2009, a cross-sectional breast cancer screening research project was developed in four cities: (a) Shenyang, located in northeast China; (b) Tianjin, situated in the coastal area of northern China; (c) Feicheng, an inland city in Shandong; and (d) Nanchang, located in southern China. A total of 21, 986 asymptomatic women, aged 45 to 69 years, volunteered to undergo breast mammography examination after signing an informed consent form. After a one-year follow-up, 65 new cases with breast cancer were diagnosed. The sensitivity and specificity of mammography were calculated on the basis of different criteria of positivity. A Markov model was used to simulate the entire screening process and calculate the cost-effectiveness ratios. The sensitivity analysis was performed using Tree Age pro 2011. The cost-effectiveness analysis was measured by the cost per life year saved (LYs), and the discounted rate was 3 %.  Results  When the defined BIRADS 0 scale (used for further imaging scan or for comparison with the previous image data to draw conclusions) was classified as negative. A total of 55 new cases with breast cancer were detected. The sensitivity was 84.6 %, the specificity was 98.6 %, and the cost-effectiveness ratio was 45 632 ￥ / Lys. Moreover, when the defined BIRADS 0 was classified as positive, 56 new cases with breast cancer were identified, with a sensitivity of 86.2 %, a specificity of 93.9 %, and a cost-effectiveness ratio of 52 392 ￥ / LYs.  Conclusion  This study suggests that different mammography-positive criteria have minimal effect on sensitivity, but a considerable effect on specificity and cost-effectiveness.