检测 HPV 阳性女性的病毒 DNA 整合以检测宫颈癌前病变：一项观察性队列研究。

Testing for viral DNA integration among HPV-positive women to detect cervical precancer: An observational cohort study.

机构信息

Department of Gynaecological Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.

National Clinical Research Centre for Obstetrics and Gynaecology, Cancer Biology Research Centre (Key Laboratory of the Ministry of Education), Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.

出版信息

BJOG. 2024 Feb;131(3):309-318. doi: 10.1111/1471-0528.17597. Epub 2023 Jul 6.

DOI:10.1111/1471-0528.17597

PMID:37408516

Abstract

OBJECTIVE

Human papillomavirus (HPV) integration is a crucial genetic step in cervical carcinogenesis. This study aimed to evaluate the performance of an HPV integration test for the triage of HPV-positive women.

DESIGN

An observational cohort study.

SETTING

A cervical cancer screening programme in China.

POPULATION

1393 HPV-positive women aged 25-65 years undergoing routine cervical cancer screening and HPV integration testing with 1-year follow-up.

METHODS

The sensitivity, specificity, positive predictive value and negative predictive value between HPV integration and cytology were compared.

MAIN OUTCOME MEASURES

Cervical intraepithelial neoplasia grade 3 or more severe (CIN3+).

RESULTS

Among 1393 HPV-positive patients, 138 (9.9% [8.3-11.5%]) were HPV integration test positive compared with 537 who had abnormal cervical cytology (38.5% [36.0-41.1%]). Compared with cytology, HPV integration exhibited higher specificity (94.5% [93.3-95.8%] versus 63.8% [61.2-66.4%]) and equivalent sensitivity (70.5% [61.4-79.7%] versus 70.5% [61.4-79.7%]) for detection of CIN3+. HPV integration-negative women accounted for 90.1% (1255/1393) of the total population and had a low immediate CIN3+ risk (2.2%). At 1-year follow-up, the progression rate in the HPV integration-positive women was higher than in the HPV integration-negative women (12.0% versus 2.1%, odds ratio 5.6, 95% CI, 2.6-11.9). In 10 conservatively managed integration-negative CIN2 patients, all showed spontaneous regression and seven showed HPV clearance after 1-year follow-up.

CONCLUSION

The HPV integration test may be a precise risk stratification tool for HPV-positive women and could avoid excessive use of invasive biopsies.

摘要

目的

人乳头瘤病毒（HPV）整合是宫颈癌发生的关键遗传步骤。本研究旨在评估 HPV 整合检测在 HPV 阳性女性中的分流作用。

设计

一项观察性队列研究。

设置

中国宫颈癌筛查项目。

人群

1393 名年龄在 25-65 岁之间的 HPV 阳性妇女，接受常规宫颈癌筛查和 HPV 整合检测，并进行为期 1 年的随访。

方法

比较 HPV 整合与细胞学之间的敏感性、特异性、阳性预测值和阴性预测值。

主要观察结果

宫颈上皮内瘤变 3 级或更高级别（CIN3+）。

结果

在 1393 名 HPV 阳性患者中，有 138 名（9.9%[8.3-11.5%]）HPV 整合检测阳性，而 537 名患者宫颈细胞学异常（38.5%[36.0-41.1%]）。与细胞学相比，HPV 整合显示出更高的特异性（94.5%[93.3-95.8%]比 63.8%[61.2-66.4%]）和相当的敏感性（70.5%[61.4-79.7%]比 70.5%[61.4-79.7%]），用于检测 CIN3+。HPV 整合阴性的妇女占总人群的 90.1%（1255/1393），其立即发生 CIN3+的风险较低（2.2%）。在 1 年随访中，HPV 整合阳性妇女的进展率高于 HPV 整合阴性妇女（12.0%比 2.1%，优势比 5.6，95%CI，2.6-11.9）。在 10 例保守治疗的整合阴性 CIN2 患者中，所有患者均出现自发消退，7 例在 1 年随访后 HPV 清除。