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目的:前瞻性、多中心根据活检病理结果验证动态乳腺光学成像相对于乳腺钼靶检查对乳腺癌诊断的灵敏度、特异度和安全性。方法:2005年6月至2006年1月北京大学人民医院和首都医科大学附属朝阳医院行钼靶检查提示需接受活检手术的患者,签署知情同意书接受动态光学乳腺成像检查,并记录患者对动态光学乳腺成像检查中舒适度、所需时间和接受程度以及发生的不良事件,由3名经过培训的医师分别对动态光学乳腺成像结果和钼靶X线片进行盲读评估,以最终病理结果作为评价标准,计算钼靶和动态光学乳腺成像对乳腺癌诊断的灵敏度和特异度。结果:以病理活检结果作为最终金标准,钼靶X线对乳腺癌诊断的灵敏度为0.935 5±0.044 1(95%可信区间0.849 0～1.022 0),特异度为0.451 6±0.089 4(95%可信区间0.276 4～0.626 8);动态光学乳腺成像对乳腺癌诊断的灵敏度为0.838 7±0.066 1(95%可信区间0.709 2～0.968 2),特异度为0.612 9±0.087 5(95%可信区间0.441 4～0.784 4)。动态光学乳腺成像(dynamic optical breast imaging,DOBI)检测中无与检测相关的不良事件发生,患者耐受性良好。结论:动态光学乳腺成像技术可以在钼靶诊断的基础上提供病变区域内异常血管分布的功能学信息,可以提高乳腺癌诊断的特异性,是一种有前景的无创乳腺功能成像技术,其临床使用范围或更准确的判读标准还需要更大样本量的临床试验研究。
OBJECTIVE: To prospectively and multicentre verify the sensitivity, specificity, and safety of dynamic mammography versus breast mammography for the diagnosis of breast cancer based on biopsy findings. Methods: From June 2005 to January 2006, Peking University People’s Hospital and the Chaoyang Hospital Affiliated to Capital Medical University performed a mammographic examination to prompt patients undergoing biopsy, signed informed consent to receive dynamic optical mammography, and recorded the patients’ Optical mammography examination comfort, time required and degree of acceptance, and adverse events were assessed by dynamic blind mammography and mammography using three trained physicians. The final pathology results were taken as Evaluation criteria to calculate the sensitivity and specificity of mammography and dynamic optical breast imaging in the diagnosis of breast cancer. Results: The sensitivity of mammography X-ray to diagnosis of breast cancer was 0.935 5 ± 0.0441 (95% confidence interval 0.849 0 ~ 1.022 0) and specificity was 0.451 6 ± 0.089 4 (95%) with pathological biopsy as the final gold standard. % Confidence interval 0.276 4-0.626 8). The diagnostic sensitivity of dynamic optical breast imaging for breast cancer was 0.838 7 ± 0.066 1 (95% confidence interval 0.709 2-0.968 2) and the specificity was 0.612 9 ± 0.087 5 (95% % Confidence interval 0.441 4 ~ 0.784 4). No adverse events associated with detection occurred in dynamic optical breast imaging (DOBI) testing, and patients were well tolerated. Conclusion: Dynamic optical mammography can provide the functional information of abnormal blood vessels distribution in the lesion area based on the mammography diagnosis, which can improve the specificity of breast cancer diagnosis. It is a promising noninvasive breast functional imaging technique and its clinical The range of use or more accurate interpretation criteria also require a larger sample size clinical trial study.