全视野数字化乳腺X线联合断层摄影对不可触及乳腺病灶的诊断价值

Full-field digital mammography combined with digital breast tomosynthesis in the diagnosis of nonpalpable breast lesions

目的探讨全视野数字乳腺X线(FFDM)联合数字断层(DBT)摄影对乳腺不可触及病灶的诊断价值。方法本前瞻性研究纳入2017年6月至2019年12月镇江市妇幼保健院临床查体阴性而影像学检查发现乳腺病灶的患者126例,共计137处病灶。术前分别采用FFDM和FFDM+DBT检查进行独立诊断,入组后行导丝定位切除活组织检查、穿刺活组织检查或真空辅助旋切,标本送病理学检查。以病理结果为金标准,绘制受试者工作特征(ROC)曲线,计算曲线下面积(AUC),用McNemar检验、Fisher精确概率法或χ^(2)检验比较2种方法的诊断效能。采用Bowker检验比较2种方法对肿块型病灶的边缘特征检查结果差异。结果FFDM和FFDM+DBT对137处不可触及乳腺病灶的总检出率分别为86.9%(119/137)、94.2%(129/137),差异有统计学意义(χ^(2)=4.249,P=0.039);在致密性乳腺中的病灶检出率分别为79.8%(71/89)、91.0%(81/89),FFDM+DBT优于FFDM(χ^(2)=4.504,P=0.034);对非致密性腺体,2种检查均可检出所有病灶。以病理结果为金标准,FFDM+DBT对全部病灶的诊断准确率高于FFDM[92.0%(126/137)比78.8%(108/137),χ^(2)=9.485,P=0.002];FFDM+DBT的AUC为0.976±0.010(95%CI:0.934~0.994),FFDM的AUC为0.821±0.037(95%CI:0.747~0.882),差异具有统计学意义(Z=4.131,P<0.001)。对于致密性腺体,FFDM+DBT的敏感度、准确率和阴性预测值均优于FFDM(P=0.008、0.012、0.037);对于非致密性腺体的检查,两种方法的各指标比较,差异均无统计学意义(P均>0.050)。对于112个肿块型病灶,FFDM+DBT的特异度、准确率及阳性预测值均高于FFDM(P=0.011;χ^(2)=9.333、5.829;P=0.002、0.016);其中,对62个良性病灶,FFDM及FFDM+DBT的清晰边缘检出率分别为54.8%(34/62)、80.6%(50/62),差异有统计学意义(Bowker T=18.000,P<0.001);对50个恶性病灶,FFDM及FFDM+DBT的毛刺征检出率分别为50%(25/50)、72%(36/50),差异有统计学意义(Bowker T=12.000,P=0.017)。对于45个可疑钙化病灶,FFDM+DBT的特异度与准确率优于FFDM[83.9%(26/31)比61.3%(19/31),P=0.046;88.9%(40/45)比71.1%(32/45),χ^(2)=4.444,P=0.035]。对于结构纠结性病灶,FFDM及FFDM+DBT的检出率分别为3/9、9/9,FFDM+DBT优于FFDM(P=0.003)。结论FFDM+DBT对于不可触及病灶的诊断效能优于FFDM,尤其对于致密性乳腺腺体。

Objective To explore the diagnostic value of full-field digital mammography(FFDM)combined with digital breast tomosynthesis(DBT)for nonpalpable breast lesions.Methods This prospective study included 126 patients with a total of 137 breast lesions which was nonpalpable in clinic but confirmed by imaging examinations in Zhenjiang Women and Children’s Hospital from June 2017 to December 2019.All patients underwent FFDM and FFDM+DBT before operation.After enrollment,the guide wire positioning excision biopsy,puncture biopsy or vacuum-assisted resection was performed,and the specimens were sent for pathological examination.With pathological results as the gold standard,the receiver operating characteristic(ROC)curve was drawn and the area under the curve(AUC)was calculated.The McNemar test,Fisher’s exact test or χ^(2) test was used to compare diagnostic power of the two methods.The Bowker test was used to analyze the differences in the edge characteristics between the two methods.Results The detection rate of 137 untouchable breast lesions by FFDM and FFDM+DBT was 86.9%(119/137)and 94.2%(129/137),indicating a significant difference(χ^(2)=4.249,P=0.039)The detection rates of lesions in dense breasts was 91.0%(81/89)by FFDM+DBT,significantly higher than79.8%(71/89)by FFDM(χ^(2)=4.504,P=0.034);all lesions in less dense breasts were detected in both examinations.Taking pathological result as the gold standard,the diagnostic accuracy of FFDM+DBT for all lesions was significantly higher than that of FFDM[92.0%(126/137)vs.78.8%(108/137),χ^(2)=9.485,P=0.002].For the diagnosis of all nonpalpable lesions,the AUC of FFDM+DBT was 0.976±0.010(95%CI:0.934-0.994),and the AUC of FFDM was 0.821±0.037(95%CI:0.747-0.882),indicating a significant difference(Z=4.131,P<0.001).For diagnosis of lesions in dense breasts,the sensitivity,accuracy and negative predictive value of FFDM+DBT were significantly higher than those of FFDM(P=0.008,0.012,0.037);for diagnosis of lesions in less dense breasts,the two methods showed no significant difference(all P>0.050).For 112 mass-type lesions,the specificity,accuracy and positive predictive value of FFDM+DBT were significantly higher than those of FFDM(P=0.011;χ^(2)=9.333,5.829;P=0.002,0.016);among them,for 62 benign lesions,the detection rate of lesions with clear edges was 54.8%(34/62)by FFDM and 80.6%(50/62)by FFDM+DBT,indicating a significant difference(Bowker T=18.000,P<0.001);for 50 malignant lesions,the detection rate of lesions with clear edges was 50%(25/50)by FFDM and 72%(36/50)by FFDM+DBT,indicating a significant difference(Bowker T=12.000,P=0.017).For 45 suspicious calcification lesions,the specificity and accuracy of FFDM+DBT were significantly higher than those of FFDM[83.9%(26/31)vs 61.3%(19/31),P=0.046;88.9%(40/45)vs 71.1%(32/45),χ^(2)=4.444,P=0.035].For structurally tangled lesions,the detection rate was 3/9 by FFDM and 9/9 by FFDM+DBT,indicating a significant difference(P=0.003).Conclusion The combination of DBT and FFDM is superior to FFDM in the diagnosis of nonpalpable breast lesions,especially in the dense breasts.