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与细胞学检查相比,高危型人乳头瘤病毒(HPV)DNA基因分型用于原发性宫颈癌筛查及HPV阳性女性分流的诊断准确性:PIPAVIR研究的初步结果

Diagnostic accuracy of high-risk HPV DNA genotyping for primary cervical cancer screening and triage of HPV-positive women, compared to cytology: preliminary results of the PIPAVIR study.

作者信息

Chatzistamatiou Kimon, Moysiadis Theodoros, Angelis Eleftherios, Kaufmann Andreas, Skenderi Alkmini, Jansen-Duerr Pidder, Lekka Irini, Kilintzis Vasilis, Angelidou Stamatia, Katsiki Evangelia, Hagemann Ingke, Tsertanidou Athena, Koch Isabel, Boecher Oliver, Soutschek Erwin, Maglaveras Nikolaos, Agorastos Theodoros

机构信息

4th Department of Obstetrics and Gynecology, Hippokratio General Hospital, Aristotle University of Thessaloniki, 49 Konstantinoupoleos st, 54642, Thessaloniki, Greece.

Institute of Applied Biosciences, Centre for Research and Technology-Hellas, 57001, Thessaloniki, Greece.

出版信息

Arch Gynecol Obstet. 2017 May;295(5):1247-1257. doi: 10.1007/s00404-017-4324-x. Epub 2017 Mar 23.

Abstract

PURPOSE

The purpose of the presented PIPAVIR (persistent infections with human papillomaviruses; http://www.pipavir.com ) subanalysis is to assess the performance of high-risk (hr) HPV-DNA genotyping as a method of primary cervical cancer screening and triage of HPV positive women to colposcopy compared to liquid-based cytology (LBC) in an urban female population.

METHODS

Women, aged 30-60, provided cervicovaginal samples at the Family-Planning Centre, Hippokratio Hospital of Thessaloniki, Greece, and the Department of Gynecology and Obstetrics in Mare Klinikum, Kiel, Germany. Cytology and HPV genotyping was performed using LBC and HPV Multiplex Genotyping (MPG), respectively. Women positive for cytology [atypical squamous cells of undetermined significance (ASC-US) or worse] or hrHPV were referred for colposcopy.

RESULTS

Among 1723/1762 women included in the final analysis, hrHPV and HPV16/18 prevalence was 17.7 and 9.6%, respectively. Cytology was ASCUS or worse in 7.6%. Cervical Intraepithelial Neoplasia grade 2 or worse (CIN2+) was detected in 28 women (1.6%). Sensitivity of cytology (ASCUS or worse) and HPV DNA testing for the detection of CIN2+ was 50.0 and 100%, and specificity was 94.49 and 85.49%, respectively. The screening approach according to which only women positive for HPV16/18 and for hrHPV(non16/18) with ASCUS or worse were referred to colposcopy presented 78.57% sensitivity and 13.17% positive predictive value (PPV).

CONCLUSIONS

HPV testing represents a more sensitive methodology for primary cervical cancer screening compared to cytology. For triage of HPV positive women to colposcopy, partial HPV genotyping offers better sensitivity than cytology, at the cost of higher number of colposcopies.

摘要

目的

本PIPAVIR(人乳头瘤病毒持续感染;http://www.pipavir.com )亚分析的目的是评估高危(hr)HPV-DNA基因分型作为宫颈癌初筛方法以及将HPV阳性女性分流至阴道镜检查的性能,与城市女性人群中的液基细胞学检查(LBC)进行比较。

方法

年龄在30至60岁的女性在希腊塞萨洛尼基希波克拉底医院计划生育中心以及德国基尔马雷临床医院妇产科提供宫颈阴道样本。分别使用LBC和HPV多重基因分型(MPG)进行细胞学检查和HPV基因分型。细胞学检查呈阳性[意义不明确的非典型鳞状细胞(ASC-US)或更严重情况]或hrHPV呈阳性的女性被转诊至阴道镜检查。

结果

在纳入最终分析的1723/1762名女性中,hrHPV和HPV16/18的患病率分别为17.7%和9.6%。细胞学检查结果为ASCUS或更严重情况的占7.6%。在28名女性(1.6%)中检测到宫颈上皮内瘤变2级或更严重(CIN2+)情况。细胞学检查(ASCUS或更严重情况)和HPV DNA检测对CIN2+的检测敏感性分别为50.0%和100%,特异性分别为94.49%和85.49%。仅将HPV16/18呈阳性以及hrHPV(非16/18)呈阳性且伴有ASCUS或更严重情况的女性转诊至阴道镜检查的筛查方法,其敏感性为78.57%,阳性预测值(PPV)为13.17%。

结论

与细胞学检查相比,HPV检测是一种更敏感的宫颈癌初筛方法。对于将HPV阳性女性分流至阴道镜检查,部分HPV基因分型比细胞学检查具有更高的敏感性,但代价是阴道镜检查数量增多。

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