甲状腺结节恶性风险分层（指南）：ACR TI-RADS与C-TIRADS诊断效能及不同医师使用指南一致性的多中心回顾性比较研究

doi:10.3877/cma.j.issn.1674-0793.2023.06.001

中华普通外科学文献(电子版) ›› 2023, Vol. 17 ›› Issue (06) : 401 -407. doi: 10.3877/cma.j.issn.1674-0793.2023.06.001

所属专题：指南共识；

论著

甲状腺结节恶性风险分层（指南）：ACR TI-RADS与C-TIRADS诊断效能及不同医师使用指南一致性的多中心回顾性比较研究

李俊, 彭健韵, 邱婉冰, 窦倩怡, 潘福顺, 梁瑾瑜^†(

)

510080　广州，中山大学附属第一医院超声科；510515　广州，南方医科大学南方医院惠侨医疗中心
510080　广州，中山大学附属第一医院超声科

收稿日期:2023-09-28 出版日期:2023-12-01
通信作者: 梁瑾瑜
基金资助:
国家自然科学基金资助项目(82001825)

Risk stratification of malignant thyroid nodules (guidelines): A comparative study of diagnostic efficacy of ACR TI-RADS versus C-TIRADS and consistency of guideline application by different physicians

Jun Li, Jianyun Peng, Wanbing Qiu, Qianyi Dou, Fushun Pan, Jinyu Liang^†()

Department of Medical Ultrasonics, the First Affiliated Hospital of Sun Yat-sen University, Guangzhou 510080, China; Huiqiao Medical Center, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China
Department of Medical Ultrasonics, the First Affiliated Hospital of Sun Yat-sen University, Guangzhou 510080, China

Received:2023-09-28 Published:2023-12-01
Corresponding author: Jinyu Liang

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引用本文：

李俊, 彭健韵, 邱婉冰, 窦倩怡, 潘福顺, 梁瑾瑜. 甲状腺结节恶性风险分层（指南）：ACR TI-RADS与C-TIRADS诊断效能及不同医师使用指南一致性的多中心回顾性比较研究[J/OL]. 中华普通外科学文献(电子版), 2023, 17(06): 401-407.

Jun Li, Jianyun Peng, Wanbing Qiu, Qianyi Dou, Fushun Pan, Jinyu Liang. Risk stratification of malignant thyroid nodules (guidelines): A comparative study of diagnostic efficacy of ACR TI-RADS versus C-TIRADS and consistency of guideline application by different physicians[J/OL]. Chinese Archives of General Surgery(Electronic Edition), 2023, 17(06): 401-407.

目的

比较使用ACR TI-RADS及C-TIRADS两种指南对甲状腺恶性结节的诊断效能、推荐细针穿刺活栓（FNA）的价值及不同医师应用指南的一致性。

方法

使用ACR TI-RADS及C-TIRADS分类方法，回顾性分析多中心医院2009年1月至2018年11月直径≥1 cm的3 018个甲状腺结节超声图像。以病理结果为"金标准"构建ROC曲线，比较两种指南的诊断效能，分析两种指南ROC曲线下面积（AUC）、敏感度、特异度、Youden指数及准确性、不必要穿刺率、是否推荐FNA的一致性。

结果

ACR TI-RADS及C-TIRADS的AUC为0.892、0.884；ACR TI-RADS的准确性、敏感度、特异度分别为0.812、0.668、0.926，C-TIRADS分别为0.811、0.735、0.870。ACR TI-RADS、C-TIRADS的不必要穿刺率分别为40.2%、31.9%；ACR TI-RADS推荐结节FNA的一致性良好，C-TIRADS推荐结节FNA一致性中等（Fleiss’s Kappa值分别为0.713、0.601）。

结论

ACR TI-RADS诊断效能优于C-TIRADS；ACR TI-RADS具有更高的特异度及AUC，C-TIRADS具有更高的敏感度。C-TIRADS的不必要穿刺率更低；ACR TI-RADS推荐FNA一致性更高。

关键词: 甲状腺结节, 细针穿刺活检, 甲状腺成像报告和数据系统, ACR TI-RADS, C-TIRADS

Objective

To compare the diagnostic efficacy of ACR TI-RADS and C-TIRADS for malignant thyroid nodules, the value of recommending fine-needle aspiration biopsy (FNA), and the consistency in the application of the guidelines by physicians.

Methods

Using the ACR TI-RADS and C-TIRADS classification methods, ultrasography images of 3 018 thyroid nodules (size≥1 cm) from January 2009 to November 2018 in 5 hospitals were retrospectively analyzed. The receiver operating characteristics (ROC) curves were constructed using pathological findings as the gold standard to compare the diagnostic efficacy of the two guidelines. Area under the ROC curve (AUC), diagnostic sensitivity, specificity, Youden index and accuracy, and consistency of whether recommending FNA were analyzed to test the clinical applicability of the two guidelines.

Results

The AUC of ACR TI-RADS and C-TIRADS were 0.892 and 0.884; the accuracy, sensitivity, and specificity of ACR TI-RADS were 0.812, 0.668, and 0.926, and of C-TIRADS were 0.811, 0.735, and 0.870. The unnecessary puncture rates for ACR TI-RADS and C-TIRADS were 40.2% and 31.9%; the concordance of FNA of the recommended nodes for ACR TI-RADS was good, while C-TIRADS was moderate (Fleiss’s Kappa=0.713 and 0.601).

Conclusions

ACR TI-RADS has better diagnostic efficacy than C-TIRADS. ACR TI-RADS has higher specificity and AUC, and C-TIRADS has higher sensitivity. C-TIRADS has lower unnecessary puncture rate and ACR TI-RADS has higher consistency in recommending FNA.

Key words: Thyroid nodules, Fine-needle aspiration biopsy, Thyroid Imaging Reporting and Data System, ACR TI-RADS, C-TIRADS

表1 数据来源及病理结果（个）

医院	结节总数	病理良性结节	病理恶性结节
中山大学附属第一医院	993	510	483
广西医科大学附属第一医院	1 300	770	530
中山大学附属第六医院	293	173	120
广州中医药大学附属第一医院	218	111	107
广州陆军总医院	214	124	90
合计	3 018	1 688	1 330

表1 数据来源及病理结果（个）

医院	结节总数	病理良性结节	病理恶性结节
中山大学附属第一医院	993	510	483
广西医科大学附属第一医院	1 300	770	530
中山大学附属第六医院	293	173	120
广州中医药大学附属第一医院	218	111	107
广州陆军总医院	214	124	90
合计	3 018	1 688	1 330

表2 甲状腺良、恶性结节一般资料的对比

项目	良性 (n=1 688)	恶性 (n=1 330)	统计值	P值
大小(mm)			17.909^a	<0.001
均数 ± 标准差	30.15±15.24	21.56±11.09
极值	10.00~75.60	10.00~95.60
超声特征[例(%)]
成分			694.154	<0.001
囊性或几乎完全囊性	198 (11.7)	1 (0.1)
海绵样	40 (2.4)	0 (0)
囊实性	487 (28.9)	17 (1.3)
实性或几乎完全实性	963 (57.0)	1 312 (98.6)
回声			935.515	<0.001
无回声	240 (14.2)	2 (0.2)
等回声或高回声	715 (42.4)	54 (4.1)
低回声	725 (43.0)	1 215 (91.4)
极低回声	8 (0.5)	59 (4.4)
形态			419.626	<0.001
纵横比<1	1 645 (97.5)	949 (71.4)
纵横比>1	43 (2.5)	381 (28.6)
边缘			993.199	<0.001
光整	917 (54.3)	74 (5.6)
模糊	727 (43.1)	847 (63.7)
分叶状或不规则	44 (2.6)	376 (28.3)
甲状腺外浸润	0 (0)	33 (2.5)
强回声			867.707	<0.001
无或大彗星尾	1 470 (87.1)	496 (37.3)
粗大钙化	88 (5.2)	129 (9.7)
边缘钙化	12 (0.7)	12 (0.9)
点状强回声	109 (6.5)	640 (48.1)
含有一种以上钙化	9 (0.5)	53 (4.0)

表2 甲状腺良、恶性结节一般资料的对比

项目	良性 (n=1 688)	恶性 (n=1 330)	统计值	P值
大小(mm)			17.909^a	<0.001
均数 ± 标准差	30.15±15.24	21.56±11.09
极值	10.00~75.60	10.00~95.60
超声特征[例(%)]
成分			694.154	<0.001
囊性或几乎完全囊性	198 (11.7)	1 (0.1)
海绵样	40 (2.4)	0 (0)
囊实性	487 (28.9)	17 (1.3)
实性或几乎完全实性	963 (57.0)	1 312 (98.6)
回声			935.515	<0.001
无回声	240 (14.2)	2 (0.2)
等回声或高回声	715 (42.4)	54 (4.1)
低回声	725 (43.0)	1 215 (91.4)
极低回声	8 (0.5)	59 (4.4)
形态			419.626	<0.001
纵横比<1	1 645 (97.5)	949 (71.4)
纵横比>1	43 (2.5)	381 (28.6)
边缘			993.199	<0.001
光整	917 (54.3)	74 (5.6)
模糊	727 (43.1)	847 (63.7)
分叶状或不规则	44 (2.6)	376 (28.3)
甲状腺外浸润	0 (0)	33 (2.5)
强回声			867.707	<0.001
无或大彗星尾	1 470 (87.1)	496 (37.3)
粗大钙化	88 (5.2)	129 (9.7)
边缘钙化	12 (0.7)	12 (0.9)
点状强回声	109 (6.5)	640 (48.1)
含有一种以上钙化	9 (0.5)	53 (4.0)

图1 ACR TI-RADS、C-TIRADS对结节诊断效能的受试者工作特征曲线

表3 ACR TI-RADS及C−TIRADS分类及与病理结果的对照[例(%)]

组别	病理良性(n=1 688)	病理恶性(n=1 330)	实际恶性率 (%)	指南推荐恶性率(%)	χ²值	P值
ACR TI-RADS					1 519.543	<0.001
TR 1	258 (15.3)	2 (0.2)	0.8	≤2
TR 2	318 (18.8)	3 (0.2)	0.9	≤2
TR 3	489 (29.0)	35 (2.6)	6.7	≤5
TR 4	498 (29.5)	401 (30.2)	44.6	5~20
TR 5	125 (7.4)	889 (66.8)	87.7	>20
C-TIRADS					1 403.123	<0.001
2	550 (32.6)	7 (0.5)	1.3	0
3	492 (29.1)	54 (4.1)	9.9	<2
4A	427 (25.3)	291 (21.9)	40.5	2~10
4B	115 (6.8)	246 (18.5)	68.1	10~50
4C	103 (6.1)	721 (54.2)	87.5	50~90
5	1 (0.1)	11 (0.8)	91.7	>90

表3 ACR TI-RADS及C−TIRADS分类及与病理结果的对照[例(%)]

组别	病理良性(n=1 688)	病理恶性(n=1 330)	实际恶性率 (%)	指南推荐恶性率(%)	χ²值	P值
ACR TI-RADS					1 519.543	<0.001
TR 1	258 (15.3)	2 (0.2)	0.8	≤2
TR 2	318 (18.8)	3 (0.2)	0.9	≤2
TR 3	489 (29.0)	35 (2.6)	6.7	≤5
TR 4	498 (29.5)	401 (30.2)	44.6	5~20
TR 5	125 (7.4)	889 (66.8)	87.7	>20
C-TIRADS					1 403.123	<0.001
2	550 (32.6)	7 (0.5)	1.3	0
3	492 (29.1)	54 (4.1)	9.9	<2
4A	427 (25.3)	291 (21.9)	40.5	2~10
4B	115 (6.8)	246 (18.5)	68.1	10~50
4C	103 (6.1)	721 (54.2)	87.5	50~90
5	1 (0.1)	11 (0.8)	91.7	>90

表4 ACR TI-RADS及C-TIRADS的诊断效能对比

组别	ACC	SEN	SPC	PPV	NPV	AUC
ACR TI-RADS	0.812	0.668	0.926	0.877	0.780	0.892
C-TIRADS	0.811	0.735	0.870	0.817	0.807	0.884
χ²值	1.133	25.697	14.493	28.938	8.435	2.660
P值	0.013	<0.001	<0.001	<0.001	0.004	0.008

表4 ACR TI-RADS及C-TIRADS的诊断效能对比

组别	ACC	SEN	SPC	PPV	NPV	AUC
ACR TI-RADS	0.812	0.668	0.926	0.877	0.780	0.892
C-TIRADS	0.811	0.735	0.870	0.817	0.807	0.884
χ²值	1.133	25.697	14.493	28.938	8.435	2.660
P值	0.013	<0.001	<0.001	<0.001	0.004	0.008

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Risk stratification of malignant thyroid nodules (guidelines): A comparative study of diagnostic efficacy of ACR TI-RADS versus C-TIRADS and consistency of guideline application by different physicians

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Risk stratification of malignant thyroid nodules (guidelines): A comparative study of diagnostic efficacy of ACR TI-RADS versus C-TIRADS and consistency of guideline application by different physicians