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甲状腺结节超声分类系统恶性预测价值的前瞻性研究。

Predictive Value of Malignancy of Thyroid Nodule Ultrasound Classification Systems: A Prospective Study.

机构信息

Department of Endocrinology and Metabolism, Ospedale Regina Apostolorum, Albano, Rome, Italy.

Department of Molecular Medicine, University La Sapienza, Rome, Italy.

出版信息

J Clin Endocrinol Metab. 2018 Apr 1;103(4):1359-1368. doi: 10.1210/jc.2017-01708.

DOI:10.1210/jc.2017-01708
PMID:29408952
Abstract

CONTEXT

British Thyroid Association (BTA), American Thyroid Association (ATA), and American Association of Clinical Endocrinologists (AACE/ACE/AME) recommend for thyroid nodules an ultrasound (US)-based stratification of risk of malignancy. Aim of our study was to assess the diagnostic accuracy of US classification systems and their reliability for indication to fine-needle aspiration (FNA).

DESIGN

Prospective study on 987 thyroid nodules consecutively referred for FNA. US images were independently reviewed by four experts for assignment of malignancy risk. Cytologically benign nodules had confirmation with a second FNA, whereas Bethesda class IV, V, and VI nodules were operated upon. Class III nodules had surgery or follow-up on the basis of clinical, immunocytochemical, and US features.

RESULTS

BTA: Malignancy rate was 2.8% in benign, 10.0% in indeterminate, 51.3% in suspicion, and 80.9% in malignant US class. Sensitivity was 0.74, specificity was 0.92, and accuracy was 0.89. ATA: Malignancy rate was 0.0% in benign, 2.2% in very low suspicion, 3.0% in low suspicion, 5.8% in intermediate, and 55.0% in high suspicion US class. Sensitivity was 0.81, specificity was 0.87, and accuracy was 0.86. AACE/ACE/AME: Malignancy rate was 1.1% in low-risk, 4.4% in intermediate-risk, and 54.9% in high-risk US class. Sensitivity was 0.82, specificity was 0.87, and accuracy was 0.86. K correlation coefficient was 78.9%, 76.9%, and 82.0% for BTA, ATA, and AACE/ACE/AME classifications.

CONCLUSIONS

Classification systems had elevated predictive value of malignancy in high-risk classes. ATA and AACE/ACE/AME systems were effective for ruling out indication to FNA in low-US-risk nodules. A similar diagnostic accuracy and a substantial interobserver agreement was provided by the three- and the five-category classifications.

摘要

背景

英国甲状腺协会(BTA)、美国甲状腺协会(ATA)和美国临床内分泌医师协会(AACE/ACE/AME)建议对甲状腺结节进行基于超声(US)的恶性风险分层。本研究旨在评估 US 分类系统的诊断准确性及其对细针抽吸(FNA)适应证的可靠性。

设计

对 987 例连续行 FNA 的甲状腺结节进行前瞻性研究。4 位专家独立对 US 图像进行复查,以评估恶性风险。细胞学良性结节采用二次 FNA 进行确认,而 Bethesda 分级 IV、V 和 VI 结节则进行手术。III 级结节根据临床、免疫细胞化学和 US 特征进行手术或随访。

结果

BTA:良性结节恶性率为 2.8%,不确定结节为 10.0%,可疑结节为 51.3%,恶性 US 分级为 80.9%。敏感性为 0.74,特异性为 0.92,准确性为 0.89。ATA:良性结节恶性率为 0.0%,非常低可疑为 2.2%,低度可疑为 3.0%,中度可疑为 5.8%,高度可疑为 55.0%。敏感性为 0.81,特异性为 0.87,准确性为 0.86。AACE/ACE/AME:低危结节恶性率为 1.1%,中危结节为 4.4%,高危结节为 54.9%。敏感性为 0.82,特异性为 0.87,准确性为 0.86。BTA、ATA 和 AACE/ACE/AME 分类的 K 相关系数分别为 78.9%、76.9%和 82.0%。

结论

分类系统对高危分级的恶性预测值较高。ATA 和 AACE/ACE/AME 系统在排除低 US 风险结节的 FNA 适应证方面效果较好。三种和五种分类系统提供了相似的诊断准确性和很大的观察者间一致性。

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