不同钼靶X线阳性标准对乳腺癌筛查成本效果的影响

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

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。

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 Shan- dong; and （d） Nanchang, located in southern China. A total of 21,986 asymptomatic women, aged 45 to 69 years, volunteered to under- go breast mammography examination after signing an informed consent form. After a one-year follow-up, 65 new cases with breast can- cer 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 fiarther imaging scan or for comparison with the previ- ous 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 marnmography-positive criteria have minimal effect on sensitivity, but a considerable effect on specificity and cost-effectiveness.