14 型 HPV mRNA 检测在 HPV DNA 阳性、细胞学正常的绝经后妇女中的分流作用。

14-type HPV mRNA test in triage of HPV DNA-positive postmenopausal women with normal cytology.

机构信息

Department of Obstetrics and Gynecology, Skåne University Hospital, Lund University, SE-22185, Lund, Sweden.

Department of Laboratory Medicine Region Skåne, Lund University, Lund, Sweden.

出版信息

BMC Cancer. 2020 Oct 23;20(1):1025. doi: 10.1186/s12885-020-07498-6.

BACKGROUND

During 2013 and 2016 the region of Skåne, Sweden started to analyse human papillomavirus (HPV) and cytology in postmenopausal women 60-65 years of age. Our aim was to evaluate high-risk (HR) HPV mRNA testing for the triage of HPV DNA-positive postmenopausal women with normal cytology.

METHODS

A total of 271 women, 60-65 years of age, underwent liquid-based cytology (LBC) and HPV testing by using the HR-HPV DNA MGP-PCR-Luminex assay. HR-HPV DNA-positive women with normal cytology underwent complimentary HPV mRNA testing (Aptima, Hologic Inc.). Over a period of 49 months (SD 11.0) the women received regular follow-ups at intervals of 12-18 months. Women with abnormal cytology and/or a positive HR-HPV DNA and/or mRNA result at two subsequent visits were scheduled for colposcopy and clinical examination.

RESULTS

Over the surveillance period, 3.6% (10/271) of the HR-HPV DNA-positive women developed histologically confirmed high-grade squamous intraepithelial lesions (HSILs) or worse. The cumulative incidence rates (CIR) were 29.7% (CI 24.8-30.1) for HSIL or worse among HPV mRNA-positive women at enrolment (39.5% 107/271) and 0% among HPV mRNA-negative women (60.5%, 164/271), (p = 0.002).

CONCLUSIONS

Postmenopausal women with normal cytology testing positive for HR-HPV mRNA are at increased risk for the development of high-grade cervical intraepithelial neoplasia (CIN), in contrast to women with a negative HR-HPV mRNA outcome. The HR-HPV mRNA APTIMA assay detecting 14 HR-HPV types may be a useful triage method among HPV DNA-positive postmenopausal women with normal cytology.

背景

2013 年至 2016 年，瑞典斯科讷地区开始对 60-65 岁绝经后女性进行人乳头瘤病毒（HPV）和细胞学分析。我们的目的是评估高危型（HR）HPV mRNA 检测在 HPV DNA 阳性且细胞学正常的绝经后妇女中的分流作用。

方法

共 271 名年龄在 60-65 岁的女性接受了液基细胞学（LBC）和 HR-HPV DNA MGP-PCR-Luminex 检测。HPV DNA 阳性且细胞学正常的 HR-HPV 女性接受了互补 HPV mRNA 检测（Aptima，豪洛捷公司）。在 49 个月（SD 11.0）的随访期内，这些女性每 12-18 个月接受一次常规随访。细胞学异常和/或两次随访中 HR-HPV DNA 和/或 mRNA 阳性的女性安排行阴道镜检查和临床检查。

结果

在监测期间，3.6%（10/271）的 HR-HPV DNA 阳性女性发展为组织学证实的高级别鳞状上皮内病变（HSIL）或更高级别病变。HPV mRNA 阳性的女性在入组时（39.5%，107/271）的累积发病率（CIR）为 HSIL 或更高级别病变为 29.7%（CI 24.8-30.1），而 HPV mRNA 阴性的女性为 0%（60.5%，164/271），（p=0.002）。

结论

细胞学正常但 HR-HPV mRNA 检测阳性的绝经后女性发生高级别宫颈上皮内瘤变（CIN）的风险增加，而 HR-HPV mRNA 阴性的女性则没有。检测 14 种 HR-HPV 型别的 HR-HPV mRNA APTIMA 检测可能是 HPV DNA 阳性且细胞学正常的绝经后女性的一种有用的分流方法。