RESULTS: Our study was embedded in Danish routine cytology-based screening. We conducted an observational study and included women born in 1994, offered the 4-valent HPV vaccine at age 14, and subsequently invited to screening at age 23. Cervical cytology was used for diagnostics and clinical management. Residual material was HPV tested with Cobas® 4800/6800. The most severe histology diagnosis within 795 days of screening was found through linkage with the Danish National Pathology Register. We calculated the number of women undergoing follow-up (repeated testing and/or colposcopy) per detected cervical intraepithelial neoplasia (CIN2+). A total of 6021 women were screened; 92% were HPV-vaccinated; 12% had abnormal cytology; 35% were high-risk HPV-positive, including 0.9% HPV16/18 positive, and 20% had follow-up. In women that were cytology-abnormal and HPV-positive (Cyt+/HPV+), 610 (98.5%) had been followed up, and 138 CIN2+ cases were diagnosed, resulting in 4.4 (95% CI 3.9-5.2) women undergoing follow-up per detected CIN2+. In contrast to recommendations, 182 (12.2%) cytology-normal and HPV-positive (Cyt-/HPV+) women were followed up within 795 days, and 8 CIN2+ cases were found, resulting in 22.8 (95% CI 13.3-59.3) women undergoing follow-up per detected CIN2+.
CONCLUSIONS: Overall, HPV prevalence was high in HPV-vaccinated women, but HPV16/18 had largely disappeared. In the large group of cytology-normal and HPV-positive women, 23 had been followed up per detected CIN2+ case. Our data indicated that primary HPV screening of young HPV-vaccinated women would require very effective triage methods to avoid an excessive follow-up burden.
BACKGROUND: Trial registration number: NCT0304955.
结果:我们的研究基于丹麦常规细胞学筛查。我们进行了一项观察性研究,纳入了1994年出生的女性,在14岁时提供了4价HPV疫苗,随后在23岁时被邀请进行筛查。宫颈细胞学检查用于诊断和临床管理。残余材料是用Cobas®4800/6800测试的HPV。通过与丹麦国家病理学登记处的联系,发现了筛查后795天内最严重的组织学诊断。我们计算了每次检测到的宫颈上皮内瘤变(CIN2)接受随访(重复测试和/或阴道镜检查)的女性人数。总共6021名妇女接受了筛查;92%的人接种了HPV疫苗;12%的人有细胞学异常;35%的人是高危型HPV阳性,包括0.9%的HPV16/18阳性,20%有随访。在细胞学异常和HPV阳性(Cyt+/HPV+)的女性中,已跟进610(98.5%),并诊断为138CIN2+病例,导致4.4(95%CI3.9-5.2)名女性接受随访,每次检测CIN2+。与建议相反,182例(12.2%)细胞学正常和HPV阳性(Cyt-/HPV+)女性在795天内随访,发现8CIN2+病例,导致22.8(95%CI13.3-59.3)女性接受随访,每次检测CIN2+。
结论:总体而言,在接种HPV疫苗的女性中,HPV的患病率很高,但HPV16/18已基本消失。在细胞学正常和HPV阳性的女性中,每个检测到的CIN2+病例随访23例。我们的数据表明,接种HPV疫苗的年轻女性的初次HPV筛查需要非常有效的分诊方法,以避免过度的随访负担。
背景:试验注册号:NCT0304955。