中国高危型人乳头瘤病毒（HPV）阳性女性中HPV基因型和年龄组的评估及甲基化分类效能

Assessment of and methylation triage efficacy across HPV genotypes and age groups in high-risk HPV-positive women in China.

作者信息

Liang Hui, Liu Yao, Yin Suyue, Jiang Mengyu, Dou Qiuyan, Wang Hanhan, Liu Jie, Chen Yibo, Liu Pei, Wang Jing, Wang Yishan, Wu Zhe

机构信息

Department of Cervical Disease, Xuzhou Maternity and Child Health Hospital, Jiangsu, China.

Department of Gynecology, Yueyang Central Hospital, Hunan, China.

出版信息

Front Oncol. 2024 Nov 26;14:1481626. doi: 10.3389/fonc.2024.1481626. eCollection 2024.

DOI:10.3389/fonc.2024.1481626

PMID:39659794

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11628385/

Abstract

OBJECTIVE

This study aimed to evaluate the clinical utility of methylation (CISCER) test in triaging high-risk human papillomavirus (hrHPV)-positive women.

METHODS

We enrolled women who underwent opportunistic screening at Cervical Disease outpatient clinics of Xuzhou Maternity and Child Health Hospital, and Yueyang Central Hospital from December 2022 to May 2024. The effectiveness of CISCER and cytology tests in triaging hrHPV+ patients was analyzed.

RESULTS

Among the 436 study participants, 283 (64.9%) had no cervical intraepithelial neoplasia (CIN), while 53 (12.2%) had CIN1, 40 (9.2%) had CIN2, 34 (7.8%) had CIN3, and 26 (5.9%) had cervical cancers. The CISCER tests identified all cases of cervical cancer, particularly 2 hrHPV-negative adenocarcinoma cases. In 396 hrHPV+ individuals, the sensitivity of CISCER tests for detecting CIN2+ lesions was 92.6% (95% CI: 87.2-97.9%), with a specificity of 95.7% (95% CI: 93.4-98%), and an area under the receiver operating characteristic curve (AUC) of 0.941 (95% CI: 0.903-0.979), outperforming cytology tests in both HPV16/18+ and non-16/18 hrHPV+ women. Notably, CISCER demonstrated 100% (95% CI: 90-100%) sensitivity in women aged≥50 and 100% (95%CI: 93.6-100%) specificity in women aged<30. Among CIN2+ women, 37.2% (including 3 cancer) showed low-grade cytological changes that could be detected by CISCER. Meanwhile, 52% of CIN2- women exhibited cytological abnormalities but had negative CISCER results. The immediate CIN3+ risk based on positive CISCER results was 54% (95% CI: 43.8-63.9%).

CONCLUSION

The / methylation detection using cervical exfoliated cells showed superior triage performance for hrHPV-positive patients compared to traditional strategies.

摘要

目的

本研究旨在评估甲基化（CISCER）检测在对高危人乳头瘤病毒（hrHPV）阳性女性进行分流中的临床效用。

方法

我们纳入了2022年12月至2024年5月期间在徐州市妇幼保健院和岳阳市中心医院宫颈疾病门诊接受机会性筛查的女性。分析了CISCER检测和细胞学检测在对hrHPV阳性患者进行分流中的有效性。

结果

在436名研究参与者中，283名（64.9%）没有宫颈上皮内瘤变（CIN），而53名（12.2%）有CIN1，40名（9.2%）有CIN2，34名（7.8%）有CIN3，26名（5.9%）有宫颈癌。CISCER检测识别出了所有宫颈癌病例，尤其是2例hrHPV阴性腺癌病例。在396名hrHPV阳性个体中，CISCER检测对检测CIN2+病变的敏感性为92.6%（95%CI：87.2 - 97.9%），特异性为95.7%（95%CI：93.4 - 98%），受试者操作特征曲线下面积（AUC）为0.941（95%CI：0.903 - 0.979），在HPV16/18阳性和非16/18 hrHPV阳性女性中均优于细胞学检测。值得注意的是，CISCER在年龄≥50岁的女性中敏感性为100%（95%CI：90 - 100%），在年龄<30岁的女性中特异性为100%（95%CI：93.6 - 100%）。在CIN2+女性中，37.2%（包括3例癌症）显示出可被CISCER检测到的低级别细胞学改变。同时，52%的CIN2-女性表现出细胞学异常但CISCER检测结果为阴性。基于CISCER阳性结果的立即发生CIN3+的风险为54%（95%CI：43.8 - 63.9%）。