澳大利亚 HPV 疫苗接种和未接种女性中基于 HPV 的细胞学筛查与初级 HPV 检测的比较：国家宫颈癌筛查计划的有效性和经济评估。

Primary HPV testing versus cytology-based cervical screening in women in Australia vaccinated for HPV and unvaccinated: effectiveness and economic assessment for the National Cervical Screening Program.

机构信息

Cancer Council NSW, Cancer Research Division, Sydney, NSW, Australia.

Cancer Council NSW, Cancer Research Division, Sydney, NSW, Australia; School of Public Health, Sydney Medical School, University of Sydney, Sydney, NSW, Australia.

出版信息

Lancet Public Health. 2017 Feb;2(2):e96-e107. doi: 10.1016/S2468-2667(17)30007-5. Epub 2017 Feb 7.

DOI:10.1016/S2468-2667(17)30007-5

PMID:29253402

Abstract

BACKGROUND

Australia's National Cervical Screening Program currently recommends cytological screening every 2 years for women aged 18-69 years. Human papillomavirus (HPV) vaccination was implemented in 2007 with high population coverage, and falls in high-grade lesions in young women have been reported extensively. This decline prompted a major review of the National Cervical Screening Program and new clinical management guidelines, for which we undertook this analysis.

METHODS

We did effectiveness modelling and an economic assessment of potential new screening strategies, using a model of HPV transmission, vaccination, natural history, and cervical screening. First, we evaluated 132 screening strategies, including those based on cytology and primary HPV testing. Second, after a recommendation was made to adopt primary HPV screening with partial genotyping and direct referral to colposcopy of women positive for HPV16/18, we evaluated the final effect of HPV screening after incorporating new clinical guidelines for women positive for HPV. Both evaluations considered both unvaccinated and vaccinated cohorts.

FINDINGS

Strategies entailing HPV testing every 5 years and either partial genotyping for HPV16/18 or cytological co-testing were the most effective. One of the most effective and cost-effective strategies comprised primary HPV screening with referral of women positive for oncogenic HPV16/18 direct to colposcopy, with reflex cytological triage for women with other oncogenic types and direct referral for those in this group with high-grade cytological findings. After incorporating detailed clinical guidelines recommendations, this strategy is predicted to reduce cervical cancer incidence and mortality by 31% and 36%, respectively, in unvaccinated cohorts, and by 24% and 29%, respectively, in cohorts offered vaccination. Furthermore, this strategy is predicted to reduce costs by up to 19% for unvaccinated cohorts and 26% for cohorts offered vaccination, compared with the current programme.

INTERPRETATION

Primary HPV screening every 5 years with partial genotyping is predicted to be substantially more effective and potentially cost-saving compared with the current cytology-based screening programme undertaken every 2 years. These findings underpin the decision to transition to primary HPV screening with partial genotyping in the Australian National Cervical Screening Program, which will occur in May, 2017.

FUNDING

Department of Health, Australia.

摘要

背景

澳大利亚国家宫颈癌筛查计划目前建议 18-69 岁的女性每 2 年进行细胞学筛查。人乳头瘤病毒（HPV）疫苗于 2007 年实施，具有较高的人群覆盖率，并广泛报道了年轻女性中高级别病变的下降。这种下降促使对国家宫颈癌筛查计划进行了重大审查，并制定了新的临床管理指南，我们为此进行了这项分析。

方法

我们使用 HPV 传播、疫苗接种、自然史和宫颈癌筛查模型，对潜在的新筛查策略进行了有效性建模和经济评估。首先，我们评估了 132 种筛查策略，包括细胞学和初级 HPV 检测。其次，在建议采用初级 HPV 筛查结合 HPV16/18 部分基因分型和直接转诊行阴道镜检查后，我们评估了 HPV 筛查在纳入 HPV 阳性女性新临床指南后的最终效果。这两种评估都考虑了未接种疫苗和接种疫苗的队列。

结果

每 5 年进行一次 HPV 检测的策略，以及 HPV16/18 部分基因分型或细胞学联合检测的策略，是最有效的。最有效和最具成本效益的策略之一是对 HPV 阳性女性直接转诊行阴道镜检查，对其他致癌 HPV 阳性女性进行细胞学三重试验，并对该组中高级别细胞学发现的女性直接转诊。在纳入详细的临床指南建议后，该策略预计可将未接种疫苗队列的宫颈癌发病率和死亡率分别降低 31%和 36%，而接种疫苗队列则分别降低 24%和 29%。此外，与现行方案相比，该策略预计可使未接种疫苗队列的成本降低 19%，接种疫苗队列的成本降低 26%。