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20 103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20 103名女性中,最常见5种HR-HPV亚型分别是HPV52、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(CIN2+)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 HPV16、33、18、31 和 58 型;其中 HPV 16、HPV18 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HPV52和HPV58,在联合不同亚型中,HPV 16/18的敏感性为55.15％,如联合HPV33,即HPV 16/18/33检出CIN2+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.
Abstract
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 20 103 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 20 103 women,the five most common HR-HPV subtypes were HPV 52,HPV 58,HPV 16,HPV 39,and HPV 51.Histological analysis of 2 045 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.
基金项目
中国妇幼健康研究会(2018AMCHS00801)
NETL
NSTL
万方数据