C-TIRADS联合cfDNA鉴别诊断甲状腺结节价值及临床效用评价

Evaluation of the value and clinical application of the Chinese thyroid imaging reports and data systems combined with circulating free DNA detection in the differential diagnosis of thyroid nodules

目的 探讨中国超声甲状腺结节恶性危险分层指南(C-TIRADS)联合循环游离DNA(cfDNA)鉴别诊断甲状腺结节价值及临床效用。方法 回顾性选取2020年3月至2022年9月于我院甲状腺外科有明确病理结果的395例甲状腺结节患者的临床资料,其中良性结节303例(良性组),恶性结节92例(恶性组)。比较2组一般资料、超声征象、C-TIRADS评分、cfDNA,采用受试者工作特征曲线(ROC)分析C-TIRADS评分、cfDNA及二者联合鉴别诊断甲状腺结节性质的价值,采用OR危险度分析C-TIRADS、cfDNA与甲状腺结节恶性风险的关系,采用临床决策曲线(DCA)分析不同鉴别诊断方案的临床效用。结果 恶性组有甲状腺癌家族史患者多于良性组(P<0.05);恶性组超声征象垂直位、极低回声、微钙化、边缘模糊或不规则或甲状腺外侵犯、实性表现患者多于良性组,彗星尾伪像患者少于良性组(P<0.05);恶性组C-TIRADS评分、cfDNA高于良性组(P<0.05);ROC分析显示,C-TIRADS、cfDNA及二者联合鉴别诊断甲状腺结节的AUC分别为0.843、0.812、0.939,C-TIRADS联合cfDNA的AUC大于C-TIRADS、cfDNA(P<0.05);OR危险度分析显示,C-TIRADS≥4分患者甲状腺结节恶性的风险是<4分患者的12.496倍(P<0.05);cfDNA≥63.70 ng/ml患者甲状腺结节恶性的风险是<63.70 ng/ml患者的9.863倍(P<0.05);绘制DCA曲线显示,C-TIRADS、cfDNA及二者联合鉴别诊断甲状腺结节均具有正向的临床净获益,且采用C-TIRADS联合cfDNA鉴别诊断时,临床效用进一步提高。结论 C-TIRADS联合cfDNA能相互弥补,提高对甲状腺结节的鉴别诊断价值,具有良好的临床效用,为临床鉴别恶性结节提供了一个无创、准确、便捷的方案,有助于提高甲状腺结节的诊疗水平。

Objective To investigate the value and clinical application of the Chinese thyroid imaging reports and data systems(C-TIRADS)combined with circulating free DNA(cfDNA)detection in the differential diagnosis of thyroid nodules.Methods It was an evaluation study of a diagnostic test.Clinical data of 395 patients with pathologically diagnosed thyroid nodules from March 2020 to September 2022 in the Department of Thyroid Surgery of our hospital were retrospectively analyzed,including 303 patients with benign nodules(benign group)and 92 with malignant nodules(malignant group).Baseline characteristics,ultrasound findings,C-TIRADS score,and cfDNA data were compared between the two groups.The receiver operating characteristic(ROC)curves were depicted to analyze the potential of C-TIRADS,cfDNA and their combination detection in the differential diagnosis of thyroid nodules.Odds ratio(OR)was calculated to identify the correlation between C-TIRADS,cfDNA and the risk of malignant thyroid nodules.The clinical application effect of C-TIRADS,cfDNA and their combination in the differential diagnosis of thyroid nodules was analyzed by the decision curve analysis(DCA).Results The proportion of patients with family history of thyroid cancer in the malignant group was significantly higher than that in the benign group(P<0.05).The proportion of patients with ultrasound signs of vertical position,very low echo masses,microcalcification,blurred or irregular margin or extrathyroidal invasion,and solid masses in the malignant group was significantly higher than that in the benign group(P<0.05),while the patients with comet-tail sign was significantly lower than that in the benign group(P<0.05).C-TIRADS score and cfDNA levels in the malignant group were significantly higher than those in the benign group(P<0.05).ROC analysis showed that the AUC of the combination detection of C-TIRADS and cfDNA level in the differential diagnosis of thyroid nodules was significantly large than that of the single detection(0.939 vs 0.843 vs 0.812,P<0.05).The OR of the risk of malignant thyroid nodules in patients with C-TIRADS≥4 points was 12.496 times of those with C-TIRADS<4 points,which,in patients with cfDNA≥63.70ng/ml was 9.863 times of those with cfDNA<63.70ng/ml(all P<0.05).DCA showed positive net benefits of the combination detection of C-TIRADS and cfDNA level and their single detection in the differential diagnosis of thyroid nodules,which were much higher in the combination detection.Conclusion C-TIRADS combined with cfDNA can complement each other and improve the differential diagnostic value of thyroid nodules,which has good clinical application as a non-invasive,accurate and convenient tool to discriminate malignant thyroid nodules.It contributes to improve the diagnosis and treatment of thyroid nodules.