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澳大利亚 HPV 疫苗接种人群中前两年 HPV 宫颈筛查的国家经验:观察性研究。

National experience in the first two years of primary human papillomavirus (HPV) cervical screening in an HPV vaccinated population in Australia: observational study.

机构信息

The Daffodil Centre, University of Sydney, a joint venture with Cancer Council NSW, Sydney NSW 2011 Australia

The Daffodil Centre, University of Sydney, a joint venture with Cancer Council NSW, Sydney NSW 2011 Australia.

出版信息

BMJ. 2022 Mar 30;376:e068582. doi: 10.1136/bmj-2021-068582.

DOI:10.1136/bmj-2021-068582
PMID:35354610
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8965648/
Abstract

OBJECTIVE

To review the first two years of the primary human papillomavirus (HPV) cervical screening programme in an HPV vaccinated population.

DESIGN

Observational study.

SETTING

Australia.

PARTICIPANTS

3 745 318 women with a primary HPV test between 1 December 2017 and 31 December 2019; most women aged <40 years had previously been offered vaccination against HPV16 and HPV18.

INTERVENTIONS

Primary HPV screening with referral if HPV16 or HPV18 (HPV16/18) positive and triage with liquid based cytology testing (threshold atypical squamous cells-cannot exclude high grade squamous intraepithelial lesion) for women who were positive for high risk HPV types other than 16/18. A 12 month follow-up HPV test was recommended in triaged women with a negative or low grade cytology result, with referral if they tested positive for any high risk HPV type at follow-up.

MAIN OUTCOME MEASURES

Proportion of women who had attended for their first HPV screening test, tested positive, and were referred for colposcopy; and short term risk of detecting cervical intraepithelial neoplasia (CIN) grade 2 or worse, CIN grade 3 or worse, or cancer.

RESULTS

54.6% (n=3 507 281) of an estimated 6 428 677 eligible women aged 25-69 had undergone their first HPV test by the end of 2019. Among those attending for routine screening, positivity for HPV16/18 and for HPV types not 16/18 was, respectively, 2.0% and 6.6% in women aged 25-69 (n=3 045 844) and 2.2% and 13.3% in highly vaccinated cohorts of women aged 25-34 (n=768 362). Colposcopy referral (ages 25-69 years) was 3.5%, increasing to an estimated 6.2% after accounting for women who had not yet had a 12 month repeat test. Cervical cancer was detected in 0.98% (456/46 330) of women positive for HPV16/18 at baseline, including 0.32% (89/28 003) of women with HPV16/18 and negative cytology. Women with HPV types not 16/18 and negative or low grade cytology at both baseline and 12 months were at low risk of serious disease (3.4% CIN grade 3 or worse; 0.02% cancer; n=20 019) but estimated to account for 62.0% of referrals for this screening algorithm.

CONCLUSIONS

Colposcopy referral thresholds need to consider underlying cancer risk; on this basis, women with HPV16/18 in the first round of HPV screening were found to be at higher risk regardless of cytology result, even in a previously well screened population. Women with HPV types not 16/18 and negative or low grade cytology showed a low risk of serious abnormalities but constitute most referrals and could be managed safely with two rounds of repeat HPV testing rather than one. HPV16/18 driven referrals were low in HPV vaccinated cohorts.

摘要

目的

回顾 HPV 疫苗接种人群中 HPV 宫颈初筛项目实施的头两年情况。

设计

观察性研究。

地点

澳大利亚。

参与者

2017 年 12 月 1 日至 2019 年 12 月 31 日期间,3745318 名接受 HPV 初筛的女性;大多数<40 岁的女性曾接受过 HPV16 和 HPV18 疫苗接种。

干预措施

HPV 初筛采用 HPV16/18 阳性时行 HPV16/18 检测和转诊,高危型 HPV 阳性但非 16/18 型时行液基细胞学检测(不典型鳞状细胞不能排除高级别鳞状上皮内病变)行分流,分流女性细胞学检查结果为阴性或低级别时行 12 个月 HPV 复查,复查阳性时行转诊。

主要观察指标

女性 HPV 初筛的参加率、HPV 阳性率、转诊行阴道镜检查率;以及短期(25-69 岁)发现宫颈上皮内瘤变(CIN)2 级及以上、CIN3 级及以上和宫颈癌的风险。

结果

2019 年底,6428677 名 25-69 岁符合条件的女性中,估计有 54.6%(n=3507281)接受了首次 HPV 检测。在接受常规筛查的女性中,25-69 岁女性 HPV16/18 阳性和非 16/18 型 HPV 阳性的比例分别为 2.0%和 6.6%(n=3045844),25-34 岁高疫苗接种率女性 HPV16/18 阳性和非 16/18 型 HPV 阳性的比例分别为 2.2%和 13.3%(n=768362)。阴道镜转诊(25-69 岁)比例为 3.5%,考虑到尚未进行 12 个月重复检查的女性,估计比例增加至 6.2%。在 HPV16/18 阳性的女性中,宫颈癌的检出率为 0.98%(456/46330),其中 HPV16/18 阳性且细胞学检查阴性的女性为 0.32%(89/28003)。HPV 阴性或细胞学低级别且阴性或低级别细胞学检查结果为阴性或低级别 12 个月的女性,严重疾病风险较低(CIN3 级及以上 3.4%;癌症 0.02%;n=20019),但据估计占该筛查算法转诊的 62.0%。

结论

阴道镜转诊阈值需要考虑潜在的癌症风险;在此基础上,HPV16/18 阳性的女性,无论细胞学结果如何,都被认为处于更高的风险,即使在以前筛查良好的人群中也是如此。HPV 阴性或细胞学低级别且阴性或低级别细胞学检查的女性,严重异常的风险较低,但构成了大多数转诊患者,可通过两轮 HPV 重复检测而不是一轮来安全管理。HPV16/18 驱动的转诊在 HPV 疫苗接种队列中较低。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0c0a/8965648/096dd2f8179c/smim068582.f4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0c0a/8965648/2d1a5325c26a/smim068582.f1.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0c0a/8965648/096dd2f8179c/smim068582.f4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0c0a/8965648/2d1a5325c26a/smim068582.f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0c0a/8965648/b348cc5e7c7b/smim068582.f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0c0a/8965648/a4ba13288711/smim068582.f3.jpg
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