阴道自取样宫颈癌筛查高危型人乳头瘤病毒检测及拓展分型的价值  

The triage value of high-risk human papillomavirus testing and extended genotyping in vaginal self-sampling forcervical cancerscreening

作　　者：李静然[1] 赵超[1] 李明珠[1] 赵昀[1] 张薇[1] 杜辉[2] 李凌[3] 林志新[4] 张志军[5] 邓继红[6] 刘蓉 胡瑛瑛 李万颖[9] 林蓓[10] 杨筱凤[11] 吴瑞芳[2] 魏丽惠[1] LI Jingran;ZHAO Chao;LI Mingzhu;ZHAO Yun;ZHANG Wei;DU Hui;LI Ling;LIN Zhixin;ZHANG Zhjun;DENG Jihong;LIU Rong;HU Yingying;LI Wanying;LIN Bei;YANG Xiaofeng;WU Ruifang;WEI Lihui(Department of Obstetrics and Gynecology,Peking University People's Hospital,Bejing,100044;Peking University Shenzhen Hospital,Shenzhen,518036;Department of Obstetrics and Gynecology,Jiangxi Maternal and Child Health Hospital,Nanchang,330006;Department of Obstetrics and Gynecology,Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region,Nanning,530003;Department of Obstetrics and Gynecology,Guizhou Provincial People's Hospital,Guiyang,550002;Department of Obstetrics and Gynecology,Kunming City Maternal and Child Health Hospital,Kunming,650031;Department of Obstetrics and Gynecology,Xining First People's Hospital,Xining,810099;Department of Obstetrics and Gynecology,The Fourth Affiliated Hospital of Zhejiang University Medical College,Yiwu,322000;Department of Obstetrics and Gynecology,The First Hospital of Jilin University,Changchun,130021;Department of Obstetrics and Gynecology,Shengjing Hospital of China Medical University,Shenyang,110020;Department of Obstetrics and Gynecology,First Affiliated Hospital of Xi'an Jiaotong University,Xi'an,710061,China)

机构地区：[1]北京大学人民医院妇产科,北京100044 [2]北京大学深圳医院妇产科,深圳518036 [3]江西省妇幼保健院妇产科,南昌330006 [4]广西壮族自治区妇幼保健院妇产科,南宁530003 [5]贵州省人民医院妇产科,贵阳550002 [6]昆明市妇幼保健院妇产科,昆明650031 [7]青海省西宁市第一人民医院妇产科,西宁810099 [8]浙江大学医学院第四附属医院妇产科,浙江义乌322000 [9]吉林大学第一医院妇产科,长春130021 [10]中国医科大学附属盛京医院妇产科,沈阳110020 [11]西安交通大学第一附属医院妇产科,西安710061

出　　处：《中国妇产科临床杂志》2024年第4期313-317,共5页Chinese Journal of Clinical Obstetrics and Gynecology

基　　金：中国妇幼健康研究会(2018AMCHS00801)。

摘　　要：目的探讨阴道自取样宫颈癌筛查高危型人乳头瘤病毒(HR-HPV)检出高级别上皮内病变(HSIL)的效果及HPV阳性拓展分型的价值。方法采用前瞻性横断面研究,于2018年9月至2020年12月在全国13个省自治区直辖市招募20103名30~59岁女性,进行基于互联网和阴道自取样的子宫颈癌筛查。分别采用二代基因测序技术或荧光PCR法检测14种HR-HPV。结果在20103名女性中,最常见5种HR-HPV亚型分别是HPV 52、58、16、39和51型。14种HR-HPV检出宫颈上皮内病变(CIN)及以上病变(CIN 2+)的敏感度、特异度、阳性预测值、阴性预测值分别是99.40%、86.85%、5.92%和99.99%。在CIN2+患者中,HR-HPV阳性前5位依次为HPV 16、33、18、31和58型;其中HPV 16、HPV 18和其他12种HPV阳性率分别是46.99%(78/166)、10.84%(18/166)和42.17%(70/166);CIN1中分别占12.92%(70/542)、7.75%(42/542)和79.34%(430/542)。HPV 16阳性检出CIN2+的敏感性最高,可达42.7%,其次是HPV 52和HPV 58,在联合不同亚型中,HPV 16/18的敏感性为55.15%,如联合HPV 33,即HPV 16/18/33检出CIN 2+的敏感性为66.67%,特异性为76.54%,虽然再联合其他HPV亚型敏感性增高,但特异度降低。结论阴道自取样HR-HPV检测用于宫颈癌筛查的效率较高,除HPV 16/18外,HPV 16/18/33拓展分型是较适合我国的分流方案,可实现同一样本筛查和分流的双重作用。Objective To investigate the efficacy of vaginal self-sampling for cervical cancer screening of high-risk human papillomavirus(HR-HPV)in detecting high-grade intraepithelial lesions(HSIL)and triage value for HPV-positive extended typing.Methods This prospective cross-sectional study,conducted from September 2018 to December 2020 across 13 provinces in China,recruited 20103 women aged 30 to 59 for vaginal self-sampling cervical cancer screening based on internet.The next generation sequencing or fluorescent PCR method were used to detect 14 kinds of HR-HPV.Results Among 20103 women,the five most common HR-HPV subtypes were HPV 52,HPV 58,HPV 16,HPV 39,and HPV 51.Histological analysis of 2045 patients revealed the sensitivity,specificity,positive predictive value,negative predictive value of CIN2+were 99.40%,86.85%,5.92%and 99.99%,respectively.In CIN2+,the top 5 HR-HPV were HPV16,HPV33,HPV18,HPV31 and HPV58,respectively.The positive rates of HPV16,HPV18 and other 12 types of HPV were 46.99%(78/166),10.84%(18/166)and 42.17%(70/166),respectively.In CIN1,it was 12.92%(70/542),7.75%(42/542)and 79.34%(430/542),respectively.Detection of CIN2+by HPV16 was the highest,up to 42.7%,followed by HPV 52 and HPV 58.In combined detection,the sensitivity of HPV 16/18 was 55.15%.Combining HPV 16/18/33 yielded a sensitivity of 66.67%and a specificity of 76.54%for CIN2+detection.Although the sensitivity of CIN2+was increased with other 12 HPV subtypes,the specificity was decreased.Conclusions Vaginal self-sampling for HR-HPV detecting proves to be an efficient method for cervical cancer screening.In addition to HPV 16/18,extended genotyping with HPV 16/18/33 serves as a suitable triage protocol,enhancing the screening and triage efficacy in a single test.

关 键 词：宫颈癌筛查 自取样 高危型人乳头瘤病毒 分流 拓展分型 

分 类 号：R737.33[医药卫生—肿瘤]