一步核酸扩增在乳腺癌前哨淋巴结转移检测中的应用  

One-step nucleic acid amplification for detecting sentinel lymph node metastasis in breast cancer

作　　者：方婉婷 商家炜 孟英爽 闫婷 明健 Wanting Fang;Jiawei Shang;Yingshuang Meng;Ting Yan;Jian Ming(Department of Pathology,General Hospital of Northern Theater Command,Shenyang 110001,China)

机构地区：[1]北部战区总医院病理科,沈阳110001

出　　处：《中华乳腺病杂志(电子版)》2025年第1期20-26,共7页Chinese Journal of Breast Disease(Electronic Edition)

基　　金：辽宁省民生科技计划联合计划资助项目(2021JH2/10300111)。

摘　　要：目的比较一步核酸扩增(OSNA)和冰冻切片法(FS)术中检测乳腺癌患者前哨淋巴结(SLN)转移情况,并评价OSNA 的诊断效能。方法前瞻性分析2021 年11 月至2023 年4 月北部战区总医院收治的116 例原发乳腺癌患者临床资料。 每位患者均行前哨淋巴结活组织检查,检出的287 枚SLN 同时进行OSNA 检测和FS 检测,以术后病理检测结果为金标准,计算OSNA 和FS 这2 种诊断方法的诊断符合率、敏感度、特异度、阳性预测值和阴性预测值。 采用Kappa 检验来判断2 种诊断方法与术后病理金标准的一致性。 采用McNemar 检验来比较OSNA、FS、串联实验、并联实验敏感度和特异度的差异。 绘制受试者操作特征曲线(ROC),并通过计算ROC 曲线下面积(AUC)比较不同诊断方法的有效性。 淋巴结转移组和未转移组的临床病理特征比较采用χ^(2)检验及Mann-Whitney 检验。结果脉管侵犯、总肿瘤负荷与SLN 转移有关(χ^(2)=16.454,P<0.001;Z=-8.876,P<0.001)。 116 例患者的OSNA 与术后病理金标准比较,诊断的总体符合率为93.1%(108/116),敏感度为95.8%(23/24),特异度为92.4%(85/92),阳性预测值为76.7%(23/30),阴性预测值为98.8%(85/86)(κ=0.808,P<0.001),其AUC 为0.941(95% CI:0.885 ~0.997,P<0.001)。 OSNA 和FS 2 种方法的敏感度比较(95.8% 比87.5%,χ^(2) =0.500,P=0.500),差异无统计学意义。 检出的287 枚SLN 中,OSNA 的诊断总体符合率为94.8%(272/287),敏感度为93.8%(30/32),特异度为94.9%(242/255),阳性预测值为69.8%(30/43),阴性预测值为99.2%(242/244)(κ=0.771,P<0.001),其AUC 为0.961(95% CI:0.911~1.000,P<0.001)。 OSNA 和FS 2 种方法的敏感度比较(93.8% 比90.6%,χ^(2)=0.333,P=1.000),差异无统计学意义。 116 例患者采用OSNA 串联FS 的敏感度为87.5%(21/24),特异度为92.4%(85/92),阳性预测值为75%(21/28),阴性预测值为96.6%(85/88),比单独使用OSNA 的敏感度更高(χ^(2)=7.111,P=0.004)。 OSNA 并联FS 的敏感度为95.8%(23/24),特异度为92ObjectiveTo compare one-step nucleic acid amplification (OSNA) technique and the frozen section (FS) method in intraoperative detection of sentinel lymph node (SLN) metastasis in breast cancer patients, and evaluate the diagnostic performance of OSNA.MethodsA prospective study was conducted on clinical data of 116 patients with primary breast cancer admitted to the General Hospital of the Northern Theater Command from November 2021 to April 2023. Each patient underwent sentinel lymph node biopsy, and 287 identified SLNs were subjected to both OSNA and FS testing. Postoperative pathological examination served as the gold standard for diagnosis. Diagnostic concordance rates, sensitivity, specificity,positive predictive value (PPV) and negative predictive value (NPV) were calculated for both OSNA and FS.Kappa test was used to assess the consistency of OSNA and FS with the postoperative pathological result (gold standard). McNemar’s test was employed to compare the sensitivity and specificity of OSNA and FS,as well as the serial and parallel combinations of the two methods. Receiver operating characteristic (ROC) curves were plotted, and the area under the curve (AUC) was calculated to compare the diagnostic efficacy of different methods. Chi-squared tests and Mann-Whitney U tests clinicopathological features between lymph node metastasis group and non-metastasis group.ResultsVascular invasion and total tumor burden were associated with SLN metastasis (χ^(2) =16.454,P<0.001;Z=-8.876,P<0.001). For the 116 patients, the diagnostic concordance rate of OSNA with postoperative pathology was 93.1% (108/116), with a sensitivity of 95.8%(23/24), specificity of 92.4% (85/92), PPV of 76.7% (23/30), and NPV of 98.8% (85/86). The kappa value was 0.808 (P<0.001) and the AUC was 0.941 (95%CI: 0.885-0.997, P<0.001). The sensitivity of OSNA and FS showed no statistically significant difference (95.8% vs 87.5%,χ^(2)=0.500,P=0.500). For the 287 SLNs, the diagnostic concordance rate of OSNA was 94.8% (272/287), with a sensitivity o

关 键 词：乳腺肿瘤 一步核酸扩增法 前哨淋巴结 转移 

分 类 号：R737.9[医药卫生—肿瘤]