人工智能辅助乳腺超声区分良恶性肿块并减少非必要穿刺活检的回顾性临床研究
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国家自然科学基金(82071931),国家重点研发计划(2022YFC3602400).


Artificial intelligence-assisted breast ultrasound for discriminating malignant and benign breast masses and reducing unnecessary biopsies: a retrospective clinical study
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Supported by National Natural Science Foundation of China (82071931) and National Key Research and Development Program (2022YFC3602400).

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    摘要:

    目的 评估人工智能(AI)辅助超声诊断系统在乳腺肿块中的诊断价值,重点分析其在优化乳腺影像报告和数据系统(BI-RADS)分类及减少非必要穿刺活检方面的作用。方法 回顾性纳入222例患者共243枚经病理确诊的乳腺肿块,由低年资医师先进行常规超声检查(US)并判读BI-RADS分类,再使用AI系统采集图像并依据BI-RADS标准进行自动化分类。将US和AI评估的BI-RADS 2~3类视为良性、4~5类视为恶性,以病理结果为金标准,比较US与AI对乳腺肿块良恶性的诊断效能。结果 病理结果显示,243枚乳腺肿块中恶性126枚(51.85%)、良性117枚(48.15%)。ROC曲线分析显示,AI诊断乳腺肿块良恶性的AUC为0.874,高于US的0.839(P<0.001)。AI诊断乳腺肿块良恶性的特异度(79.49%)和阳性预测值(83.33%)均优于US(分别为70.94%、78.21%),但灵敏度(95.24%)和阴性预测值(93.94%)略低于US(分别为96.83%、95.40%)。在BI-RADS 4a类肿块中,AI的诊断准确度(73.91%)高于US(57.50%)。AI将15枚US BI-RADS 4a类肿块降级,其中13枚(86.67%)为良性,从而避免了穿刺活检;但出现2枚(13.33%)假阴性。结论 AI辅助乳腺超声诊断系统可提高低年资医师对乳腺肿块的诊断效能,并有助于对US BI-RADS 4a类肿块降级,从而减少不必要的穿刺活检。然而,AI在识别非典型或隐匿性病变方面仍存在局限性,需结合临床信息综合判断。

    Abstract:

    Objective To evaluate the diagnostic value of an artificial intelligence (AI)-assisted breast ultrasound system in the assessment of breast masses, with a focus on analyzing its role in optimizing Breast Imaging Reporting and Data System (BI-RADS) classification and reducing unnecessary biopsies. Methods A total of 243 pathologically confirmed breast masses from 222 patients were retrospectively included. Conventional ultrasonograpny (US) and BI-RADS classification were performed by junior physicians, and an AI system was used to collect images and perform automatic classification according to BI-RADS standards. BI-RADS 2-3 assessed by US and AI were regarded as benign, while BI-RADS 4-5 were defined as malignant. Pathological results were used as the gold standard to compare the diagnostic efficacy of US and AI. Results Pathological examination revealed 126 (51.85%) malignant and 117 (48.15%) benign lesions among the 243 breast masses. Receiver operating characteristic (ROC) curve analysis showed that the AI system achieved an area under curve (AUC) of 0.874 for discriminating malignant and benign breast masses, significantly higher than the 0.839 of US (P< 0.001). The specificity and positive predictive value of AI were 79.49% and 83.33%, respectively, which were better than the 70.94% and 78.21% of the US, whereas the sensitivity (95.24% vs 96.83%) and negative predictive value (93.94% vs 95.40%) were slightly lower. In BI-RADS 4a masses, the diagnostic accuracy of AI (73.91%) was higher than that of US (57.50%). AI downgraded 15 cases of BI-RADS 4a masses, of which 13 cases (86.67%) were benign, thus avoiding unnecessary biopsy; yet there were 2 cases (13.33%) of false negatives. Conclusion This AI-assisted breast ultrasound system can improve the diagnostic performance of junior physicians and enable accurate downgrading of BI-RADS 4a masses, thereby reducing unnecessary biopsies. However, it still has limitations in identifying atypical or occult lesions and requires comprehensive judgment based on clinical information.

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  • 收稿日期:2025-08-26
  • 最后修改日期:2025-12-08
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  • 在线发布日期: 2026-01-23
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