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value of ultrasound-based thyroid nodule malignancy risk stratification in differentiating malignant and benign thyroid nodule
between C-TIRADS and 2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and
Differentiated Thyroid Cancer:the American Thyroid Association Guidelines Task Force on Thyroid Nodules and Differentiated
Thyroid Cancer(ATA guidelines for short). Methods A total of 336 inpatients who underwent surgery and ultrasound
examination in Bozhou People's Hospital from January 2019 to May 2021 were selected as participants. Four ultrasonologists with
a title higher than attending physician were equally randomized into groups A and B for evaluating ultrasonic examination results
according to ultrasound-based thyroid nodule malignancy risk stratification in C-TIRADS and ATA guidelines,respectively.
The accuracies of ultrasound-based thyroid nodule malignancy stratification in the two guidelines in differentiating malignant and
benign thyroid nodules were assessed using intraoperative or postoperative pathological findings(gold standard for diagnosis),
and were further analyzed using ROC analysis. Results According to intraoperative or postoperative pathological findings,
the participants had 367 thyroid nodules in total,including 253 benign nodules and 114 malignant nodules. The nodules were
classified as follows according to the TI-RADS in the C-TIRADS by ultrasonologists in group A:(1)253 benign nodules:
2 were in TI-RADS 5 category,23,30,and 80 were in categories 4c,4b,and 4a,respectively, 103 were in 3 category,
and 15 were in 2 category;(2)114 malignant nodules:24 were in TI-RADS 5 category,59 were in 4c category,22 were
in 4b category,6 were in 4a category and 3 were in 3 category. And the classification of nodules according to the ATA guideline
by ultrasonologists in group B was:(1)253 benign nodules:13,53,47,118 were high,intermediate,low,and very
low suspicion pattern for malignancy,respectively,and 22 were benign pattern;(2)114 malignant nodules:76,24,
8,6 were high,intermediate,low,and very low suspicion pattern for malignancy,respectively. ROC analysis showed that,
AUCs of ultrasound-based thyroid nodule malignancy risk stratification in differentiating malignant and benign thyroid nodules
between C-TIRADS and ATA guidelines were 0.890〔95%CI(0.815,0.918)〕and 0.780〔95%CI(0.750,0.876)〕,
with significant difference(Z=13.62,P<0.05). The TI-RADS in the C-TIRADS showed 92.11% sensitivity,78.26%
specificity,82.56% accuracy,with Youden index of 0.70 in differentiating 4b category benign and malignant nodules,and
demonstrated 97.37% sensitivity,46.64% specificity,62.40% accuracy with Youden index of 0.44 in differentiating 4a category
benign and malignant nodules. The ultrasound-based thyroid nodule malignancy risk stratification in ATA guideline showed
87.72% sensitivity,67.98% specificity,74.11% accuracy,with Youden index of 0.56 in differentiating intermediate suspicion
pattern for malignancy,and demonstrated 94.74% sensitivity,44.66% specificity,60.22% accuracy with Youden index of
0.39 in differentiating low suspicion pattern for malignancy. Conclusion The ultrasound-based thyroid nodule malignancy risk
stratification in C-TIRADS has higher value in differentiating malignant and benign thyroid nodules than that in ATA guidelines,
and the optimal performance of which may be manifested in differentiating malignant and benign thyroid nodules of TI-RADS 4b
category.
【Key words】 Thyroid nodule;Diagnosis,differential;Ultrasonography;Guidebook;Comparative study
随着超声检查设备的革新和超声检查技术的改进, 1 资料与方法
近年来我国甲状腺结节检出率明显升高 [1] ,临床医生 1.1 一般资料 选取 2019 年 1 月至 2021 年 5 月在亳
和患者也越来越重视甲状腺结节良恶性的鉴别诊断。为 州市人民医院住院并行手术治疗和超声检查的甲状腺结
规范地诊断和治疗甲状腺结节,国内外先后发布了多项 节患者 336 例,其中男 108 例,女 228 例;年龄 13~76 岁,
指南 [2-9] ,但由于不同国家制定的指南基于不同的国情、 中位年龄 47 岁;结节直径为 0.7~3.5 cm,中位结节直
病历资料和研究结果,因此在临床应用中仍具有局限性。 径为 2.7 cm。所有患者经术中或术后病理检查证实存在
2020 年发布的《甲状腺结节超声恶性危险分层中国指 甲状腺结节。排除标准:在超声检查前进行过甲状腺结
南》 [10] (以下简称 C-TIRADS)提出了甲状腺结节超 节有创操作或相关治疗;病历资料不完整。
声恶性风险分层方法,该方法与 2015 年美国甲状腺学 1.2 超声检查方法 参照中国医师协会超声医师分会
会(ATA)发布的《成人甲状腺结节与分化型甲状腺癌 制定的《血管和浅表器官超声检查指南》 [11] 中甲状腺
诊治指南》 [5] (以下简称 ATA 指南)中的甲状腺结节 超声检查要求,扫查所有患者甲状腺及其内结节,并选
超声恶性风险分层方法相比,在甲状腺结节评估、分类 取典型图像进行存储,最后将所有静态图像和动态图像
标准上存在相似之处,但哪种方法对甲状腺结节良恶性 保存在本地电脑上或报告系统工作站内。本研究所用超
的鉴别诊断价值更优?目前报道较少。本研究旨在探讨 声检查仪器为美国 GE LOGIQ E10 和 P7、德国西门子
C-TIRADS 与 ATA 指南中甲状腺结节超声恶性风险分 OXANA3 和 S3000、日本东芝 790、意大利百胜 CLASS C、
层方法对甲状腺结节良恶性的鉴别诊断价值。 中国迈瑞 DC-8 型彩色多普勒超声诊断仪,采用线阵高