[Differential diagnosis model of benign and malignant breast BI-RADS category 4 nodules based on serum SP70 and conventional laboratory indicators].

Objective: To develop a nomogram model for the differential diagnosis of benign and malignant breast BI-RADS (Breast Imaging Reporting and Data System) category 4 nodules based on serum tumor specific protein 70 (SP70) and conventional laboratory indicators and validate its predictive efficacy. Methods: A case-control study design was used to retrospectively analyze the data of 429 female patients diagnosed with BI-RADS category 4 breast nodules by breast color doppler flow imaging at the First Affiliated Hospital of Nanjing Medical University from January 2021 to April 2022 with an age range of 16 to 91 years and a median age of 50 years, and the patients were divided into a training cohort (314 patients) and a validation cohort (115 patients) according to the inclusion time successively. Using postoperative pathological findings as the"gold standard", univariate and multivariate logistic regression analyses were used to identify the predictor variables used for the model. The nomogram, receiver operating characteristic (ROC) curves and calibration curves were drawn for the prediction model, and the discrimination and calibration of the model were evaluated using the consistency index (C-index) and calibration plots. Results: The postoperative pathological results showed that 286 (66.7%) were malignant nodules and 143 (33.3%) were benign nodules of 429 breast BI-RADS category 4 nodules. The serum SP70 (OR=1.227,95%CI: 1.033-1.458,P=0.020), NLR (OR=1.545,95%CI: 1.047-2.280,P=0.028), LDL-C (OR=2.215, 95%CI: 1.354-3.622, P=0.002), GLU (OR=2.050,95%CI:1.222-3.438,P=0.007), PT (OR=1.383,95%CI: 1.046-1.828,P=0.023), nodule diameter (OR=1.042, 95%CI: 1.008-1.076, P=0.015) and age (OR=1.062,95%CI: 1.011-1.116,P=0.016) were independent risk factors which could be used to distinguish benign and malignant breast BI-RADS category 4 nodules (P<0.05). The nomogram was plotted by the above seven independent variables, and the concordance index (C-index) for the training cohort and validation cohort were 0.842 (95%CI:0.786-0.898) and 0.787 (95%CI:0.687-0.886), respectively. The sensitivity and specificity of using this model to identify benign and malignant breast BI-RADS category 4 nodules in the training and validation cohort were 83.5%, 72.5% and 79.2%, 73.6%, respectively. The calibration curves showed good agreement between the predicted and actual values in the nomogram. Conclusions: This study combined serum SP70, conventional laboratory indicators and breast color doppler flow imaging to develop a nomogram model for the differential diagnosis of benign and malignant breast BI-RADS category 4 nodules. The model may have good predictive efficacy and may provide a basis for clinical treatment options, which is beneficial for guiding breast cancer screening and prevention.目的： 建立基于血清肿瘤特异性蛋白70（tumor specific protein 70，SP70）和常规实验室指标的针对乳腺乳腺影像学报告和数据系统（Breast Imaging Reporting and Data System，BI-RADS）4类结节良恶性鉴别诊断的列线图模型，并验证其预测效能。 方法： 采用队列研究设计，回顾性分析2021年1月至2022年4月在南京医科大学第一附属医院通过乳腺彩色多普勒超声诊断为BI-RADS 4类乳腺结节的429例女性患者资料，年龄范围为16~91岁，中位数年龄50岁。依据病例纳入时间的先后，将患者分为建模组（314例）和验证组（115例）。以术后的病理结果为金标准，使用单因素和多因素logistic回归分析确定用于模型的预测变量并绘制列线图及预测模型的受试者工作特征（receiver operating characteristic，ROC）曲线和校准图，使用一致性指数（C-index）和校准曲线对模型的区分度和校准度进行评价。 结果： 术后病理结果显示429例乳腺BI-RADS 4类结节中286例（66.7%）为恶性结节，143例（33.3%）为良性结节。血清SP70（OR=1.227，95%CI：1.033~1.458，P=0.020）、NLR（OR=1.545，95%CI：1.047~2.280，P=0.028）、LDL-C（OR=2.215，95%CI：1.354~3.622，P=0.002）、GLU（OR=2.050，95%CI：1.222~3.438，P=0.007）、PT（OR=1.383，95%CI：1.046~1.828，P=0.023）、结节长径（OR=1.042，95%CI：1.008~1.076，P=0.015）及年龄（OR=1.062，95%CI：1.011~1.116，P=0.016）是用于鉴别乳腺BI-RADS 4类结节良恶性的独立影响因素（P<0.05），将上述7个变量纳入模型绘制列线图，建模组及验证组的一致性指数（C-index）分别为0.842（95%CI：0.786~0.898）和0.787（95%CI：0.687~0.886）。建模组和验证组使用该模型鉴别乳腺BI-RADS 4类结节良恶性的敏感度、特异度分别为83.5%、72.5%和79.2%、73.6%，校准曲线显示列线图预测值与实际值之间具有良好的一致性。 结论： 本研究联合血清SP70水平、常规实验室指标及乳腺彩色多普勒超声指标，建立术前乳腺BI-RADS 4类结节良恶性鉴别诊断列线图模型。此模型可能具有良好的预测效能，可为临床治疗方案选择提供参考依据，可能有利于指导乳腺癌的筛查和预防。.