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E7信使核糖核酸在人乳头瘤病毒16型阳性女性中预测进展为高级别鳞状上皮内病变/宫颈上皮内瘤变2级风险的效用

Usefulness of E7 mRNA in HPV16-Positive Women to Predict the Risk of Progression to HSIL/CIN2.

作者信息

Martí Cristina, Marimón Lorena, Glickman Ariel, Henere Carla, Saco Adela, Rakislova Natalia, Torné Aureli, Ordi Jaume, Del Pino Marta

机构信息

Institute Clinic of Gynaecology, Obstetrics, and Neonatology, Hospital Clínic, University of Barcelona, 08036 Barcelona, Spain.

Institut de Salut Global de Barcelona (ISGlobal), Hospital Clínic, University of Barcelona, 08036 Barcelona, Spain.

出版信息

Diagnostics (Basel). 2021 Sep 7;11(9):1634. doi: 10.3390/diagnostics11091634.

Abstract

OBJECTIVE

To evaluate whether E7 mRNA can predict the risk of progression in women with HPV16 infection.

DESIGN

A prospective observational study.

SETTING

A tertiary university hospital.

POPULATION

A cohort of 139 women referred to colposcopy for an abnormal screening result fulfilling the following inclusion criteria: (1) a positive test result confirming HPV16 infection; (2) a biopsy sample with a histological diagnosis of an absence of lesion or low-grade SIL/CIN grade1 (LSIL/CIN1); (3) no previous HPV vaccination; (4) no pregnancy; and (5) no previous cervical treatments; and (6) no immunosuppression.

METHODS

At the first visit, all women underwent a cervical sample for liquid-based cytology, HPV testing and genotyping, and HPV16 E7 mRNA analysis and a colposcopy with at least one colposcopy-guided biopsy. Follow-up visits were scheduled every six months. In each control, a liquid-based Pap smear, HPV testing, as well as a colposcopy examination with biopsy if necessary were performed.

MAIN OUTCOME MEASURES

Histological diagnosis of HSIL/CIN2+ at any time during follow-up.

RESULTS

E7 mRNA expression was positive in 55/127 (43.3%) women included in the study and seven (12.7%) progressed to HSIL/CIN2+. In contrast, only 1/72 (1.4%) women with no HPV16 E7 mRNA expression progressed ( = 0.027). HPV16 E7 mRNA expression was associated with a 10-fold increased risk of progression (HR 10.0; 95% CI 1.2-81.4).

CONCLUSIONS

HPV16 E7 mRNA could be useful for risk stratification of women with HPV16 infection in whom a HSIL/CIN2+ has been ruled out.

FUNDING

Instituto de Salud Carlos III (ICSIII)-Fondo de Investigación Sanitaria and ERDF 'One Way to Europe' (PI17/00772).

摘要

目的

评估E7信使核糖核酸(mRNA)是否能预测人乳头瘤病毒16型(HPV16)感染女性的病情进展风险。

设计

一项前瞻性观察性研究。

地点

一家三级大学医院。

研究对象

一组139名因筛查结果异常而转诊至阴道镜检查的女性,她们符合以下纳入标准:(1)HPV16感染检测结果呈阳性;(2)活检样本的组织学诊断为无病变或低级别鳞状上皮内病变/宫颈上皮内瘤变1级(LSIL/CIN1);(3)既往未接种HPV疫苗;(4)未怀孕;(5)既往未接受过宫颈治疗;(6)无免疫抑制。

方法

初次就诊时,所有女性均接受宫颈样本进行液基细胞学检查、HPV检测与基因分型、HPV16 E7 mRNA分析以及阴道镜检查,并至少进行一次阴道镜引导下的活检。随访安排为每六个月一次。每次复查时,进行液基巴氏涂片检查、HPV检测,必要时进行阴道镜检查及活检。

主要观察指标

随访期间任何时间点的高级别鳞状上皮内病变/宫颈上皮内瘤变2级及以上(HSIL/CIN2+)的组织学诊断。

结果

纳入研究的127名女性中,55名(43.3%)E7 mRNA表达呈阳性,其中7名(12.7%)进展为HSIL/CIN2+。相比之下,E7 mRNA无表达的72名女性中只有1名(1.4%)病情进展(P = 0.027)。HPV16 E7 mRNA表达与病情进展风险增加10倍相关(风险比10.0;95%置信区间1.2 - 81.4)。

结论

对于已排除HSIL/CIN2+的HPV16感染女性,HPV16 E7 mRNA可用于风险分层。

资助

卡洛斯三世卫生研究所(ICSIII) - 卫生研究基金及欧洲区域发展基金“通往欧洲的一条道路”(PI17/00772)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cd33/8468571/f13b3df6f548/diagnostics-11-01634-g001.jpg

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