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甲状腺结节(thyroid nodule,TN)是指甲状腺细胞在甲状腺局部异常生长所引起的散在病变,临床常见,发病影响因素较多[1]。临床上,甲状腺炎症、甲状腺腺瘤和甲状腺囊肿等甲状腺疾病均可表现为TN。TN可为单发和多发,多发TN概率较高,但单发TN癌变风险较高[2]。TN多数为良性病变,少数为恶性病变。甲状腺癌前期无明显的临床特征,易漏诊,这使其发病风险在世界范围内显著增加[3],因此对TN的诊断及治疗至关重要。
目前,由于超声具有优异的时空分辨率,其已成为诊断和评估TN的首选检测技术,尤其是对于无症状的甲状腺癌[4]。随着临床上高频超声的广泛应用,TN的检出概率可达到68%[5]。评估TN的发生风险可帮助临床医师对其治疗方式进行选择。临床上采用甲状腺影像报告和数据系统(thyroid imaging reporting and data system,TIRADS)以提高诊断TN的准确率。2017年美国放射学会(American College of Radiology,ACR)提出的TIRADS(ACR-TIRADS)已在我国临床工作中广泛应用[6];同年,欧洲甲状腺协会也发布了成人TN超声恶性风险分层指南,即欧洲甲状腺协会甲状腺影像报告和数据系统(简称EU-TIRADS)[7]。2种TIRADS版本不同,其分层依据也不同,尚无统一标准[8]。目前,关于不同版本TIRADS的研究多数是对TIRADS诊断效能的研究,一致性研究较少,而可重复性和一致性对其是否能在临床上普及和推广十分重要。本研究就TN患者的ACR-TIRADS和EU-TIRADS资料进行综合评价,探究二者的诊断一致性及影响因素,从而为TN患者的诊断和预后以及TIRADS的临床适用性提供参考依据。
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282例患者共检测出320个TN,其中FNA检测出166个TN(118个良性TN、48个恶性TN);手术检测出154个TN(30个良性TN,124个恶性TN)。
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由表1可知,TN的恶性风险均随着ACR-TIRADS和EU-TIRADS分类类别升高而增加。 ACR-TIRADS和EU-TIRADS构建ROC曲线的结果显示,其AUC分别为0.812(95%CI:0.771~0.853)和0.795(95%CI:0.754~0.836),约登指数最大值分别为0.544、0.531,所对应的临界值均为5类(图1)。
甲状腺结节 ACR-TIRADS[例(%)] EU-TIRADS[例(%)] 1类 2类 3类 4类 5类 2类 3类 4类 5类 良性结节(n=148) 4(2.70) 30(20.27) 29(19.59) 49(33.11) 36(24.32) 5(3.38) 55(37.16) 31(20.95) 57(38.51) 恶性结节(n=172) 0(0.00) 2(1.16) 3(1.74) 32(18.60) 135(78.49) 0(0.00) 6(3.49) 9(5.23) 157(91.28) 恶性风险(%) 0(0.00) 6.25 9.38 39.51 78.95 0(0.00) 9.84 22.50 73.36 注:数字1~5表示不同的分类类别。ACR-TIRADS为美国放射学会甲状腺影像报告和数据系统;EU-TIRADS为欧洲甲状腺协会甲状腺影像报告和数据系统 表 1 ACR-TIRADS和EU-TIRADS对甲状腺结节的恶性风险分析
Table 1. Malignant risk analysis of thyroid nodule in American College of Radiology-thyroid imaging reporting and data system and European Thyroid Association-thyroid imaging reporting and data system
图 1 ACR-TIRADS和EU-TIRADS鉴别诊断甲状腺结节良恶性的受试者工作特征曲线
Figure 1. Receiver operating characteristic curves for differential diagnosis of benign and malignant thyroid nodules using American College of Radiology-thyroid imaging reporting and data system and European Thyroid Association-thyroid imaging reporting and data system
ACR-TIRADS和EU-TIRADS的诊断准确率(78.01%对77.62%)、阳性预测值(78.95%对73.36%)的差异均无统计学意义(χ2=0.036、2.796,P=0.849、0.095);EU-TIRADS较ACR-TIRADS的诊断阴性预测值(85.74%对74.75%)、灵敏度(91.54%对79.31%)均更高,差异均有统计学意义(χ2=12.034、19.135,P=0.001、<0.001);ACR-TIRADS较EU-TIRADS的诊断特异度(75.67%对62.38%)更高,差异有统计学意义(χ2=12.900,P<0.001)。
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由表2、表3可知,ACR-TIRADS 2~4类无论是良性还是恶性TN均与EU-TIRADS 2~4类一致性良好。由表4可知,ACR-TIRADS和EU-TIRADS一致性分析结果显示,ACR-TIRADS 2类中所有TN(18个)均与EU-TIRADS 2类相对应;ACR-TIRADS 3类中有77个TN(96.25%,77/80)与EU-TIRADS 3类相对应;ACR-TIRADS 4类中有70个TN(94.59%,70/74)与EU-TIRADS 4类相对应;ACR-TIRADS 5类中有94个TN(63.51%,94/148)与EU-TIRADS 4类相对应,另外ACR-TIRADS 5类中有54个TN(36.49%,54/148)与EU-TIRADS 5类相对应。
ACR-TIRADS EU-TIRADS 合计 Kappa值 P值 准确率(%) 2 3 4 5 2 0(0.00) 0(0.00) 0(0.00) 0(0.00) 0(0.00) 0.375 <0.001 − 3 1(0.58) 8(4.65) 0(0.00) 0(0.00) 9(5.23) − − − 4 0(0.00) 0(0.00) 30(17.44) 0(0.00) 30(17.44) − − − 5 0(0.00) 0(0.00) 85(49.42) 48(27.91) 133(77.33) − − − 合计 1(0.58) 8(4.65) 115(66.86) 48(27.91) 172(100.00) − − 50.00 注:数字2~5表示不同的分类类别;−表示无此项数据。ACR-TIRADS为美国放射学会提出的甲状腺影像报告与数据系统;EU-TIRADS为欧洲甲状腺协会提出的甲状腺影像报告与数据系统 表 2 ACR-TIRADS和EU-TIRADS对恶性甲状腺结节检查结果的一致性分析[例(%)]
Table 2. Consistency analysis of American College of Radiology-thyroid imaging reporting and data system and European-thyroid imaging reporting and data system in the examination results of malignant thyroid nodule (cases (%))
ACR-TIRADS EU-TIRADS 合计 Kappa值 P值 准确率(%) 2 3 4 5 2 18(12.16) 0(0.00) 0(0.00) 0(0.00) 18(12.16) 0.844 <0.001 − 3 2(1.35) 69(46.62) 0(0.00) 0(0.00) 71(47.97) − − − 4 0(0.00) 2(1.35) 40(27.03) 2(1.35) 44(29.73) − − − 5 0(0.00) 0(0.00) 9(6.08) 6(4.05) 15(10.14) − − − 合计 20(13.51) 71(47.97) 49(33.11) 8(5.41) 148(100.00) − − 89.86 注:数字2~5表示不同的分类类别;−表示无此项数据。ACR-TIRADS为美国放射学会提出的甲状腺影像报告与数据系统;EU-TIRADS为欧洲甲状腺协会提出的甲状腺影像报告与数据系统 表 3 ACR-TIRADS和EU-TIRADS对良性甲状腺结节检查结果的一致性分析[例(%)]
Table 3. Consistency analysis of American College of Radiology-thyroid imaging reporting and data system and European-thyroid imaging reporting and data system in the examination results of benign thyroid nodule (cases (%))
ACR-TIRADS EU-TIRADS 合计 Kappa值 P值 准确率(%) 2 3 4 5 2 18(5.63) 0(0.00) 0(0.00) 0(0.00) 18(5.63) 0.571 <0.001 − 3 3(0.94) 77(24.06) 0(0.00) 0(0.00) 80(25.00) − − − 4 0(0.00) 2(0.63) 70(21.88) 2(0.63) 74(23.13) − − − 5 0(0.00) 0(0.00) 94(29.38) 54(16.88) 148(46.25) − − − 合计 21(6.56) 79(24.69) 164(51.25) 56(17.50) 320(100.00) − − 68.44 注:数字2~5表示不同的分类类别;−表示无此项数据。ACR-TIRADS为美国放射学会提出的甲状腺影像报告与数据系统;EU-TIRADS为欧洲甲状腺协会提出的甲状腺影像报告与数据系统 表 4 ACR-TIRADS和EU-TIRADS对甲状腺结节检查结果的一致性分析[例(%)]
Table 4. Consistency analyzing of American College of Radiology-thyroid imaging reporting and data system and European-thyroid imaging reporting and data system in the examination results of thyroid nodules (cases (%))
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ACR-TIRADS和EU-TIRADS检查结果相符的A组TN共219个,不相符的B组TN共 101个。A、B 2组的超声诊断特征比较结果显示,结节长径(10~15 mm、≥20 mm)、囊性或几乎囊性、海绵样结节、低和(或)中低回声、圆形、边缘以及微钙化均是ACR-TIRADS和EU-TIRADS检查结果不相符的相关因素,差异均有统计学意义(均P<0.05,表5)。多因素Logistic回归分析结果显示,结节长径<20 mm、海绵样结节、低和(或)中低回声、圆形、边缘模糊以及微分叶边缘,均是2种系统检查结果不相符的独立危险因素(均P<0.05,图2)。
组别 结节长径 结构 5~10 mm 10~15 mm 15~20 mm ≥20 mm 囊性或几乎囊性 囊实性 实性或几乎实性 海绵样结节 A组(n=219) 25(11.42) 42(19.18) 39(17.81) 113(51.60) 19(8.68) 54(24.66) 136(62.10) 10(4.57) B组(n=101) 14(13.86) 42(41.58) 23(22.77) 22(21.78) 2(1.98) 21(20.79) 61(60.40) 17(16.83) χ2值 0.386 17.925 1.090 25.195 5.054 0.576 0.085 13.460 P值 0.534 <0.001 0.296 <0.001 0.025 0.448 0.771 <0.001 组别 回声 形状 边缘 高回声或等回声 低和(或)
中低回声极和(或)
显著低回声卵圆形 圆形 直立生长
(纵横比值>1)光滑 模糊 A组(n=219) 98(44.75) 77(35.16) 44(20.09) 175(79.91) 2(0.91) 42(19.18) 187(85.39) 7(3.20) B组(n=101) 35(34.65) 51(50.50) 15(14.85) 80(79.21) 8(7.92) 13(12.87) 53(52.48) 13(12.87) χ2值 2.900 6.773 1.262 0.021 11.212 1.932 39.934 11.042 P值 0.089 0.009 0.261 0.885 0.001 0.165 <0.001 0.001 组别 边缘 钙化 微分叶 针刺样边缘 甲状腺外侵犯 粗大钙化 边缘钙化 微钙化 孤立性性钙化 A组(n=219) 12(5.48) 11(5.02) 2(0.91) 12(5.48) 5(2.28) 62(28.31) 3(1.37) B组(n=101) 16(15.84) 14(13.86) 5(4.95) 8(7.92) 1(0.99) 17(16.83) 0(0.00) χ2值 9.296 7.497 5.266 0.703 0.628 4.899 1.397 P值 0.002 0.006 0.022 0.402 0.428 0.027 0.237 注:ACR-TIRADS为美国放射学会甲状腺影像报告和数据系统;EU-TIRADS为欧洲甲状腺协会甲状腺影像报告和数据系统 表 5 ACR-TIRADS和EU-TIRADS检查结果相符与不相符2组患者超声诊断特征比较[例(%)]
Table 5. Comparison of ultrasound diagnostic characteristics between two groups of patients with consistent or inconsistent American College of Radiology-thyroid imaging reporting and data system and European-thyroid imaging reporting and data system examination results (cases (%))
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经Bootstrap法内部验证后C指数相同,多因素Logistic回归模型预测ACR-TIRADS和EU-TIRADS检查结果不相符情况与实际情况一致。校准图显示,Logistic回归预测模型与标准曲线拟合度良好(图3A)。通过临床决策曲线评估模型对预测ACR-TIRADS和EU-TIRADS检查结果不相符风险的临床净获益情况。模型阈值概率在0.01~0.94区间时,净获益率>0(图3B)。
ACR-TIRADS和EU-TIRADS在甲状腺结节诊断中的一致性及差异原因分析
Analysis of consistency and difference between ACR-TIRADS and EU-TIRADS in the diagnosis of thyroid nodules
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摘要:
目的 探究美国放射学会(ACR)提出的甲状腺影像报告和数据系统(TIRADS)与欧洲甲状腺协会提出的TIRADS(简称EU-TIRADS)在甲状腺结节(TN)诊断中的一致性及差异原因。 方法 回顾性分析2019年6月至2022年1月于来安家宁医院(272例)和南京医科大学附属南京医院(10例)经细针穿刺活检或手术组织病理学检查结果确诊的282例TN患者的年龄、性别、TN情况(大小、个数、结构、回声、形状、边缘、钙化)、ACR-TIRADS和EU-TIRADS检查结果等资料,其中男性72例、女性210例,年龄(45.9±10.9)岁。计量资料的组间比较采用两独立样本t检验;计数资料的组间比较采用χ2检验。采用McNemar配对χ2检验比较二者的诊断准确率;采用多分类资料的Kappa检验进行一致性分析;以2种系统检查结果相符为A组,不相符为B组,比较2组的超声诊断特征;采用多因素Logistics回归预测模型分析2种系统检查结果不相符的独立危险因素;采用临床决策曲线评价模型的精准度。 结果 TN的恶性风险均随着ACR-TIRADS和EU-TIRADS分类类别升高而增加。二者相比,EU-TIRADS较ACR-TIRADS的灵敏度更高(91.54%对79.31%),差异有统计学意义(χ2=19.135,P<0.001);ACR-TIRADS较EU-TIRADS的特异度更高(75.67%对62.38%),差异有统计学意义(χ2=12.900,P<0.001)。ACR-TIRADS 2~4类无论是良性还是恶性TN均与EU-TIRADS 2~4类一致性良好。Logistic回归分析结果显示,结节长径<20 mm(OR=1.196,95%CI:1.005~1.422,P<0.001)、海绵样结节(OR=1.119,95%CI:1.022~1.226,P=0.016)、低和(或)中低回声(OR=1.627,95%CI:1.031~1.732,P=0.011)、圆形(OR=1.072,95%CI:1.012~1.134,P=0.022)、边缘模糊(OR=1.567,95%CI:1.063~1.683,P<0.001)、微分叶边缘(OR=1.169,95%CI:1.051~1.301,P=0.004)均是二者检查结果不相符的独立危险因素。 结论 EU-TIRADS较ACR-TIRADS对TN诊断的灵敏度高、特异度低;二者对2~4类TN的检查结果一致性良好。 -
关键词:
- 甲状腺结节 /
- 甲状腺肿瘤 /
- 影响因素分析 /
- 甲状腺影像报告与数据系统
Abstract:Objective To explore the consistency and difference between the thyroid imaging reporting and data system proposed by American College of Radiology (ACR-TIRAD) and European Thyroid Association (EU-TIRADS) in the diagnosis of thyroid nodule (TN). Methods Patients with TN admitted to Lai'an Jianing Hospital (272 cases) and Nanjing Hospital Affiliated to Nanjing Medical University (10 cases) from June 2019 to January 2022 were selected as the study subjects. A total of 282 patients with TN diagnosed via fine needle aspiration biopsy or histopathological examination were recruited, and their age, sex, TN characteristics (size, number, structure, echo, shape, margin, and calcification), ACR-TIRADS and EU-TIRADS results were recorded. A total of 72 males and 210 females, aged (45.9±10.9) years were included. Measurement data were compared by utilizing two independent samples t-test, and count data were compared by using χ2 test. McNemar paired χ2 test was applied to compare the diagnostic accuracy of the two classification systems. Kappa test of multiclassification data was used to analyze consistency. The results of two kinds of system examination were consistent as group A, and not consistent as group B, and the ultrasonic diagnostic characteristics of the two groups were compared. Analysis of independent risk factors with inconsistent results of the two systems by using multi-factor Logistics regression prediction model. The accuracy of the model was evaluated by clinical decision curve. Results The malignant risk of TN increased with the increase in ACR-TIRADS and EU-TIRADS classification. EU-TIRADS was significantly more sensitive than ACR-TIRADS (91.54% vs. 79.31%) , the difference between the two systems was is statistically significant (χ2=19.135, P<0.001). ACR-TIRADS had significantly higher specificity than EU-TIRADS (75.67% vs. 62.38%), the difference is statistically significant (χ2=12.900 P<0.001). Benign and malignant TN in ACR-TIRADS system 2–4 were consistent with those in EU-TIRADS system 2–4. Logistic regression analysis showed that TN measuring<20 mm (OR=1.196, 95%CI: 1.005–1.422, P<0.001), spongiform TN (OR=1.119, 95%CI: 1.022–1.226, P=0.016), low/middle/low echo (OR=1.627, 95%CI: 1.031–1.732, P=0.011), round shape (OR=1.072, 95%CI: 1.012–1.134, P=0.022), blurred edges (OR=1.567, 95%CI: 1.063–1.683, P<0.001), and differential lobe margins (OR=1.169, 95%CI: 1.051–1.301, P=0.004) were all independent risk factors for inconsistency between the results of the two examination systems. Conclusion EU-TIRADS has higher sensitivity and lower specificity than ACR-TIRADS in the diagnosis of TN, and the test results of the two methods for type 2−4 TN are in good agreement. -
图 1 ACR-TIRADS和EU-TIRADS鉴别诊断甲状腺结节良恶性的受试者工作特征曲线
Figure 1. Receiver operating characteristic curves for differential diagnosis of benign and malignant thyroid nodules using American College of Radiology-thyroid imaging reporting and data system and European Thyroid Association-thyroid imaging reporting and data system
表 1 ACR-TIRADS和EU-TIRADS对甲状腺结节的恶性风险分析
Table 1. Malignant risk analysis of thyroid nodule in American College of Radiology-thyroid imaging reporting and data system and European Thyroid Association-thyroid imaging reporting and data system
甲状腺结节 ACR-TIRADS[例(%)] EU-TIRADS[例(%)] 1类 2类 3类 4类 5类 2类 3类 4类 5类 良性结节(n=148) 4(2.70) 30(20.27) 29(19.59) 49(33.11) 36(24.32) 5(3.38) 55(37.16) 31(20.95) 57(38.51) 恶性结节(n=172) 0(0.00) 2(1.16) 3(1.74) 32(18.60) 135(78.49) 0(0.00) 6(3.49) 9(5.23) 157(91.28) 恶性风险(%) 0(0.00) 6.25 9.38 39.51 78.95 0(0.00) 9.84 22.50 73.36 注:数字1~5表示不同的分类类别。ACR-TIRADS为美国放射学会甲状腺影像报告和数据系统;EU-TIRADS为欧洲甲状腺协会甲状腺影像报告和数据系统 表 2 ACR-TIRADS和EU-TIRADS对恶性甲状腺结节检查结果的一致性分析[例(%)]
Table 2. Consistency analysis of American College of Radiology-thyroid imaging reporting and data system and European-thyroid imaging reporting and data system in the examination results of malignant thyroid nodule (cases (%))
ACR-TIRADS EU-TIRADS 合计 Kappa值 P值 准确率(%) 2 3 4 5 2 0(0.00) 0(0.00) 0(0.00) 0(0.00) 0(0.00) 0.375 <0.001 − 3 1(0.58) 8(4.65) 0(0.00) 0(0.00) 9(5.23) − − − 4 0(0.00) 0(0.00) 30(17.44) 0(0.00) 30(17.44) − − − 5 0(0.00) 0(0.00) 85(49.42) 48(27.91) 133(77.33) − − − 合计 1(0.58) 8(4.65) 115(66.86) 48(27.91) 172(100.00) − − 50.00 注:数字2~5表示不同的分类类别;−表示无此项数据。ACR-TIRADS为美国放射学会提出的甲状腺影像报告与数据系统;EU-TIRADS为欧洲甲状腺协会提出的甲状腺影像报告与数据系统 表 3 ACR-TIRADS和EU-TIRADS对良性甲状腺结节检查结果的一致性分析[例(%)]
Table 3. Consistency analysis of American College of Radiology-thyroid imaging reporting and data system and European-thyroid imaging reporting and data system in the examination results of benign thyroid nodule (cases (%))
ACR-TIRADS EU-TIRADS 合计 Kappa值 P值 准确率(%) 2 3 4 5 2 18(12.16) 0(0.00) 0(0.00) 0(0.00) 18(12.16) 0.844 <0.001 − 3 2(1.35) 69(46.62) 0(0.00) 0(0.00) 71(47.97) − − − 4 0(0.00) 2(1.35) 40(27.03) 2(1.35) 44(29.73) − − − 5 0(0.00) 0(0.00) 9(6.08) 6(4.05) 15(10.14) − − − 合计 20(13.51) 71(47.97) 49(33.11) 8(5.41) 148(100.00) − − 89.86 注:数字2~5表示不同的分类类别;−表示无此项数据。ACR-TIRADS为美国放射学会提出的甲状腺影像报告与数据系统;EU-TIRADS为欧洲甲状腺协会提出的甲状腺影像报告与数据系统 表 4 ACR-TIRADS和EU-TIRADS对甲状腺结节检查结果的一致性分析[例(%)]
Table 4. Consistency analyzing of American College of Radiology-thyroid imaging reporting and data system and European-thyroid imaging reporting and data system in the examination results of thyroid nodules (cases (%))
ACR-TIRADS EU-TIRADS 合计 Kappa值 P值 准确率(%) 2 3 4 5 2 18(5.63) 0(0.00) 0(0.00) 0(0.00) 18(5.63) 0.571 <0.001 − 3 3(0.94) 77(24.06) 0(0.00) 0(0.00) 80(25.00) − − − 4 0(0.00) 2(0.63) 70(21.88) 2(0.63) 74(23.13) − − − 5 0(0.00) 0(0.00) 94(29.38) 54(16.88) 148(46.25) − − − 合计 21(6.56) 79(24.69) 164(51.25) 56(17.50) 320(100.00) − − 68.44 注:数字2~5表示不同的分类类别;−表示无此项数据。ACR-TIRADS为美国放射学会提出的甲状腺影像报告与数据系统;EU-TIRADS为欧洲甲状腺协会提出的甲状腺影像报告与数据系统 表 5 ACR-TIRADS和EU-TIRADS检查结果相符与不相符2组患者超声诊断特征比较[例(%)]
Table 5. Comparison of ultrasound diagnostic characteristics between two groups of patients with consistent or inconsistent American College of Radiology-thyroid imaging reporting and data system and European-thyroid imaging reporting and data system examination results (cases (%))
组别 结节长径 结构 5~10 mm 10~15 mm 15~20 mm ≥20 mm 囊性或几乎囊性 囊实性 实性或几乎实性 海绵样结节 A组(n=219) 25(11.42) 42(19.18) 39(17.81) 113(51.60) 19(8.68) 54(24.66) 136(62.10) 10(4.57) B组(n=101) 14(13.86) 42(41.58) 23(22.77) 22(21.78) 2(1.98) 21(20.79) 61(60.40) 17(16.83) χ2值 0.386 17.925 1.090 25.195 5.054 0.576 0.085 13.460 P值 0.534 <0.001 0.296 <0.001 0.025 0.448 0.771 <0.001 组别 回声 形状 边缘 高回声或等回声 低和(或)
中低回声极和(或)
显著低回声卵圆形 圆形 直立生长
(纵横比值>1)光滑 模糊 A组(n=219) 98(44.75) 77(35.16) 44(20.09) 175(79.91) 2(0.91) 42(19.18) 187(85.39) 7(3.20) B组(n=101) 35(34.65) 51(50.50) 15(14.85) 80(79.21) 8(7.92) 13(12.87) 53(52.48) 13(12.87) χ2值 2.900 6.773 1.262 0.021 11.212 1.932 39.934 11.042 P值 0.089 0.009 0.261 0.885 0.001 0.165 <0.001 0.001 组别 边缘 钙化 微分叶 针刺样边缘 甲状腺外侵犯 粗大钙化 边缘钙化 微钙化 孤立性性钙化 A组(n=219) 12(5.48) 11(5.02) 2(0.91) 12(5.48) 5(2.28) 62(28.31) 3(1.37) B组(n=101) 16(15.84) 14(13.86) 5(4.95) 8(7.92) 1(0.99) 17(16.83) 0(0.00) χ2值 9.296 7.497 5.266 0.703 0.628 4.899 1.397 P值 0.002 0.006 0.022 0.402 0.428 0.027 0.237 注:ACR-TIRADS为美国放射学会甲状腺影像报告和数据系统;EU-TIRADS为欧洲甲状腺协会甲状腺影像报告和数据系统 -
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