The value of liquid-based thinprep cytologic test and high-risk human papillomavirus test in the screening of cervical cancer and precancerous lesions
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摘要:
目的 评价与比较液基薄层细胞学检查(liquid-based thinprep cytologic test, TCT)、高危型人乳头瘤病毒(high-risk human papillomavirus, HR-HPV)检查在宫颈癌及癌前病变筛查中的价值,为宫颈癌及癌前病变单项筛查方法的选择提供初步依据。 方法 收集2006年2月25日―2019年10月15日在深圳市人民医院妇科因体检进行TCT、HR-HPV和阴道镜及组织病理学检查的5 657名女性资料。细胞学阳性结果包括未明确诊断意义的不典型鳞状上皮细胞(atypical squamous cells of undetermined significance, ASC-US)及以上病变。计数资料的比较采用χ2检验,采用Logistic回归分析模型分别分析HR-HPV感染、TCT阳性与宫颈癌及癌前病变(低度宫颈上皮内瘤变及以上病变)的关系。 结果 HR-HPV阳性例数为3 857例,阳性率为68.18%。HR-HPV检查筛查宫颈癌及癌前病变的灵敏度、阳性预测值、阴性预测值均高于TCT(82.39% vs. 55.34%、51.80% vs. 47.35%、76.28% vs. 61.64%;均有P<0.001),但其特异度低于TCT(42.48% vs. 53.84%;P<0.001)。Logistic回归分析模型结果显示,HR-HPV感染女性患宫颈癌及癌前病变的风险(OR=3.42, 95% CI: 3.02~3.88, P < 0.001)高于TCT阳性女性(OR=1.48, 95% CI: 1.33~1.65, P < 0.001)。 结论 HR-HPV检查在宫颈癌及癌前病变筛查中的价值高于TCT。 Abstract:Objective To evaluate and compare the value of liquid-based thinprep cytologic test (TCT) and high-risk human papillomavirus (HR-HPV) test in the screening of cervical cancer and precancerous lesions, and provide the preliminary basis for the selection of single screening method for cervical cancer and precancerous lesions. Methods The data of 5 657 women who underwent TCT, HR-HPV test, colposcopy and histopathological examinations for health examination in the gynecological outpatient department of Shenzhen People's Hospital from February 25, 2006 to October 15, 2019 were collected. Cytological positive results included atypical squamous cells of undetermined significance (ASC-US) and above lesions. Count data were compared using χ2 test, and the Logistic regression analysis model was performed to analyze the relationship between HR-HPV infection, TCT positive and cervical cancer and precancerous lesions (low-grade cervical intraepithelial neoplasia and above lesions), respectively. Results The number of HR-HPV positive women (the positive rate) was 3 857 (68.18%). The sensitivity, positive predictive value, and negative predictive value of HR-HPV test in the screening of cervical cancer and precancerous lesions were all higher than TCT (82.39% vs. 55.34%, 51.80% vs. 47.35%, 76.28% vs. 61.64%; all P < 0.001), but its specificity was lower than TCT (42.48% vs. 53.84%, P < 0.001). Logistic regression analysis model showed that the risk of cervical cancer and precancerous lesions for HR-HPV positive women (OR=3.42, 95% CI: 3.02-3.88, P < 0.001) was higher than that for TCT positive women (OR=1.48, 95% CI: 1.33-1.65, P < 0.001). Conclusion The value of HR-HPV test in screening cervical cancer and precancerous lesions is higher than that of TCT. -
表 1 受检女性的基本特征[n(%)]
Table 1. Basic characteristics of the tested women [n(%)]
变量 受检女性 年龄(岁, x±s) 21~<31 26.56±2.61 31~<41 35.31±2.84 41~<51 44.91±2.85 51~<65 55.62±3.85 HR-HPV 阳性 3 857(68.18) 阴性 1 800(31.82) TCT ASC-US及以上病变 2 834(50.10) 正常 2 823(49.90) 病理 低度CIN及以上病变 2 425(42.87) 正常 3 232(57.13) 表 2 TCT、HR-HPV检查筛查宫颈癌及癌前病变的评价分析[% (95% CI)]
Table 2. Evaluation and analysis of TCT and HR-HPV test in screening cervical cancer and precancerous lesions [% (95% CI)]
筛查方法 灵敏度 特异度 阳性预测值 阴性预测值 一致率 TCT 55.34(53.35~57.31) 53.84(52.11~55.55) 47.35(45.52~49.19) 61.64(59.83~63.41) 54.48(53.18~55.78) HR-HPV 82.39(80.82~83.86) 42.48(40.79~44.19) 51.80(50.22~53.38) 76.28(74.26~78.19) 59.59(58.31~60.86) P值 <0.001 <0.001 <0.001 <0.001 <0.001 表 3 HR-HPV感染、TCT阳性与宫颈癌及癌前病变危险性分析
Table 3. The analysis of HR-HPV infection, TCT positive and the risk of cervical cancer and precancerous lesions
筛查方法 病理阳性例数 病理阴性例数 OR(95% CI)值 P值 HR-HPV 3 857 1 800 3.42(3.02~3.88) <0.001 TCT 2 834 2 823 1.48(1.33~1.65) <0.001 -
[1] Bray F, Ferlay J, Soerjomataram I, et al. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries [J]. CA: A Cancer J Clin, 2018, 68(6): 394-424. DOI: 10.3322/caac.21492. [2] 中华人民共和国卫生健康委员会. 2019中国卫生健康统计年鉴[M]. 北京: 中国协和医科大学出版社, 2019.National Health Commission of the People's Republic of China. China's Hygiene and Health Statistical Yearbook 2019 [M]. Beijing: China Union Medical University Press, 2019. [3] 王慧, 王彤, 胡尚英, 等. 四种宫颈癌筛查方法的预测值比较[J]. 中华流行病学杂志, 2013, 34(2): 191-194. DOI: 10.3760/cma.j.issn.0254-6450.2013.02.020.Wang H, Wang T, Hu SY, et al. Comparison on the predictive values of four screening methods regarding cervical cancer [J]. Chin J Epidemiol, 2013, 34(2): 191-194. DOI: 10.3760/cma.j.issn.0254-6450.2013.02.020. [4] US Preventive Services Task Force, Curry SJ, Krist AH, et al. Screening for cervical cancer: US preventive services task force recommendation statement [J]. JAMA, 2018, 320(7): 674-686. DOI: 10.1001/jama.2018.10897. [5] Di J, Rutherford S, Chu C. Review of the cervical cancer burden and population-based cervical cancer screening in China [J]. Asian Pac J Cancer Prev, 2015, 16(17): 7401-7407. DOI: 10.7314/apjcp.2015.16.17.7401. [6] Solomon D, Davey D, Kurman R, et al. The 2001 Bethesda System: terminology for reporting results of cervical cytology [J]. JAMA, 2002, 287(16): 2114-2119. DOI: 10.1001/jama.287.16.2114. [7] 李琴, 蔡建平, 陈炳香, 等. 不同年龄段高风险女性HPV感染率及感染亚型分布状况分析[J]. 中国性科学, 2015, 24(9): 69-71. DOI: 10.3969/j.issn.1672-1993.2015.09.023.Li Q, Cai JP, Chen BX, et al. Analysis of infection and genotype of HPV for women of different ages [J]. Chin J Hum Sex, 2015, 24(9): 69-71. DOI: 10.3969/j.issn.1672-1993.2015.09.023. [8] Schiffman M, Castle PE, Jeronimo J, et al. Human papillomavirus and cervical cancer [J]. Lancet, 2007, 370(9590): 890-907. DOI: 10.1016/s0140-6736(07)61416-0. [9] Bosch FX, Lorincz A, Muñoz N, et al. The causal relation between human papillomavirus and cervical cancer [J]. J Clin Pathol, 2002, 55(4): 244-265. DOI: 10.1136/jcp.55.4.244. [10] Wang R, Guo XL, Wisman GB, et al. Nationwide prevalence of human papillomavirus infection and viral genotype distribution in 37 cities in China [J]. BMC Infect Dis, 2015, 15: 257. DOI: 10.1186/s12879-015-0998-5. [11] Liang H, Fu M, Zhou J, et al. Evaluation of 3D-CPA, HR-HPV, and TCT joint detection on cervical disease screening [J]. Oncol Lett, 2016, 12(2): 887-892. DOI: 10.3892/ol.2016.4677. [12] 胡丽芳. TCT联合HR-HPV在宫颈癌前病变筛查中的应用[J]. 中国妇幼保健, 2018, 33(1): 205-208. DOI: 10.7620/zgfybj.j.issn.1001-4411.2018.01.71.Hu LF. Application of TCT combined with HR-HPV in screening cervical precancerous lesions [J]. Matern and Child Heal Care of China, 2018, 33(1): 205-208. DOI: 10.7620/zgfybj.j.issn.1001-4411.2018.01.71. [13] Ruan G, Song Y, Dong B, et al. Cervical cancer screening using the Cervista high-risk human papillomavirus test: opportunistic screening of a hospital-based population in Fujian Province, China [J]. Cancer Manag Res, 2018, 10: 3227-3235. DOI: 10.2147/cmar.s169822. [14] 张劲丰, 安宏亮, 苏荣. 应用HC-Ⅱ法筛查宫颈病变的临床评价[J]. 现代检验医学杂志, 2010, 25(5): 85-87. DOI: 10.3969/j.issn.1671-7414.2010.05.032.Zhang JF, An HL, Su R. Application of hybrid capture Ⅱ method of laboratory evaluation of screening for cervical lesions [J]. J Mod Lab Med, 2010, 25(5): 85-87. DOI: 10.3969/j.issn.1671-7414.2010.05.032. [15] 查庆兵, 帅翰林, 潘观玉. 中国女性HPV感染与CIN及宫颈癌发病相关性的系统分析[J]. 广州医学院学报, 2012, 40(6): 6-10. DOI: 10.3969/j.issn.1008-1836.2012.06.002.Zha QB, Shuai HL, Pan GY. Correlation between Chinese women with human papillomavirus infection and cervical intraepithelial neoplasm and cervical cancer: a Meta-analysis [J]. Acad J Guangzhou Med Coll, 2012, 40(6): 6-10. DOI: 10.3969/j.issn.1008-1836.2012.06.002. [16] Dillner J, Rebolj M, Birembaut P, et al. Long term predictive values of cytology and human papillomavirus testing in cervical cancer screening: joint European cohort study [J]. BMJ, 2008, 337: a1754. DOI: 10.1136/bmj.a1754.