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在 HR-HPV 检测呈阳性且同时伴有低度鳞状上皮内病变(LSIL)细胞学结果的女性中,使用扩展的 HR-HPV 基因分型改善 2019 年美国阴道镜和子宫颈病理学会(ASCCP)建议的分流策略。

Use of extended HR-HPV Genotyping in improving the Triage Strategy of 2019 ASCCP recommendations in Women with positive HR-HPV diagnosis and Simultaneous LSIL Cytology Results.

作者信息

Xue Huifeng, Gao Hangjing, Zheng Jinwen, Chen Yaojia, Chen Jiancui, Pan Diling, Dong Binhua, Sun Pengming

机构信息

Fujian Provincial Cervical Disease Diagnosis and Treatment Health Center, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou 350001, Fujian, P.R. China.

Department of Gynecology, Laboratory of Gynecologic Oncology, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou 350001, Fujian, P.R. China.

出版信息

J Cancer. 2021 May 19;12(14):4332-4340. doi: 10.7150/jca.55826. eCollection 2021.

Abstract

According to the 2019 American Society for Colposcopy and Cervical Pathology (ASCCP) recommendations, women with a positive high-risk human papillomavirus (HR-HPV) diagnosis and low-grade cervical intraepithelial lesion (LSIL) cytology result should be referred for further colposcopy examination. However, this strategy results in over-treatment in several cases. In this study, we assessed the performance of extended HR-HPV genotyping in women with a simultaneous positive HR-HPV and LSIL diagnosis with the aim of improving the current triage strategy. This study was an observational analysis of women from the Fujian Province Cervical Lesion Screening Cohorts (FCLSCs). Women who were HR-HPV-positive and had a cytological examination of LSIL, which were followed up with colposcopy and biopsy, from 2015 to 2018 were included. The study endpoint was defined as the detection of histological cervical intraepithelial neoplasia grade 2 or worse (CIN2+). We combined HR-HPV genotypes according to the prevalence rate in histological CIN2+ and ranked them from high to low to establish HR-HPV genotyping models. Outcomes were assessed with respect to sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and colposcopy referral rate. Overall, 56,788 women undergoing preliminary screening for HR-HPV genotyping were included in this study. Among them, 10,499 women positive for HR-HPV underwent a cytology examination, and 902 women with LSIL cytology diagnosed and subsequent biopsy results were included in the final evaluation. Among these patients, 25.1% (226/902) were found to have CIN2+ in histology. HPV-16, -58, -52, -18, -33, and -31 infections were the most common genotypes, and HPV-16, -18, -58, -33, and -31 (odds ratio [OR] = 5.41, 2.98, 1.38, 1.24, and 1.21, respectively) were associated with the potential for histological CIN2+, from the highest to lowest. In the detection of CIN2+ lesions in HR-HPV-positive LSIL women of different HR-HPV genotyping models, the extended HPV 16/18/31/33/52/58 genotyping model was found to have better efficacy with higher sensitivity (92.9%) and NPV (93.0%), but a significantly lower colposcopy referral rate (74.7%) than the ASCCP-recommended HR-HPV non-genotyping model. For HR-HPV-positive women with LSIL, the HPV 16/18/31/33/52/58 genotyping model can serve as an alternative approach to the ASCCP recommendations, potentially reducing the unnecessary colposcopy referral burden in China.

摘要

根据2019年美国阴道镜检查和宫颈病理学会(ASCCP)的建议,高危型人乳头瘤病毒(HR-HPV)检测结果呈阳性且宫颈细胞学检查结果为低度鳞状上皮内病变(LSIL)的女性应转诊接受进一步的阴道镜检查。然而,这一策略在一些病例中导致了过度治疗。在本研究中,我们评估了扩展HR-HPV基因分型在同时HR-HPV检测阳性和LSIL诊断的女性中的效能,旨在改进当前的分流策略。本研究是对福建省宫颈病变筛查队列(FCLSCs)中的女性进行的一项观察性分析。纳入了2015年至2018年期间HR-HPV检测阳性且进行了LSIL细胞学检查,并随后接受了阴道镜检查和活检的女性。研究终点定义为组织学诊断为宫颈上皮内瘤变2级或更高级别(CIN2+)。我们根据组织学CIN2+中的流行率对HR-HPV基因型进行合并,并将它们从高到低排序以建立HR-HPV基因分型模型。通过灵敏度、特异度、阳性预测值(PPV)、阴性预测值(NPV)和阴道镜转诊率来评估结果。总体而言,本研究纳入了56788名接受HR-HPV基因分型初步筛查的女性。其中,10499名HR-HPV检测阳性的女性接受了细胞学检查,902名诊断为LSIL细胞学且有后续活检结果的女性被纳入最终评估。在这些患者中,25.1%(226/902)在组织学上被发现患有CIN2+。HPV-16、-58、-52、-18、-33和-31感染是最常见的基因型,HPV-16、-18、-58、-33和-31(优势比[OR]分别为5.41、2.98、1.38、1.24和1.21)与组织学CIN2+的可能性相关,从高到低。在不同HR-HPV基因分型模型的HR-HPV阳性LSIL女性中检测CIN2+病变时,发现扩展的HPV 16/18/31/33/52/58基因分型模型具有更好的效能,灵敏度更高(92.9%)和NPV更高(93.0%),但阴道镜转诊率显著低于ASCCP推荐的HR-HPV非基因分型模型(74.7%)。对于HR-HPV阳性且LSIL的女性,HPV 16/18/31/33/52/58基因分型模型可作为ASCCP建议的替代方法,有可能减轻中国不必要的阴道镜转诊负担。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7419/8176432/cae7764a5420/jcav12p4332g001.jpg

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