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肛门癌筛查中自我采集与临床医生采集拭子的比较:一项临床试验。

Self- versus clinician-collected swabs in anal cancer screening: A clinical trial.

作者信息

Dyer Clare E F, Jin Fengyi, Roberts Jennifer M, Poynten I Mary, Farnsworth Annabelle, McNally Leon P, Cunningham Philip H, Grulich Andrew E, Hillman Richard J

机构信息

Kirby Institute, University of New South Wales, Sydney, NSW, Australia.

Douglass Hanly Moir Pathology, Sydney, NSW, Australia.

出版信息

PLoS One. 2025 Jan 9;20(1):e0312781. doi: 10.1371/journal.pone.0312781. eCollection 2025.

DOI:10.1371/journal.pone.0312781
PMID:39787107
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11717180/
Abstract

BACKGROUND

Risk of anal cancer is high in certain populations and screening involves collection of anal swabs for HPV DNA and/or cytology testing. However, barriers exist, such as the need for an intimate examination, and stigma around HIV status, sexual orientation, and sexual practices. Self-collected anal swabs (SCA) are a proposed alternative to clinician-collected swabs (CCA) to overcome these barriers.

METHODS

Participants were order-randomised to undergo SCA or CCA first, with a second swab taken immediately afterwards. Sample adequacy was assessed for HPV DNA and cytology testing. CCA was used as the gold standard to calculate sensitivity and specificity of SCA for cytology and HPV results. Acceptability of swab collection was assessed following the procedure.

RESULTS

There was no significant difference in sample validity for HPV DNA testing between SCA and CCA (p = 0.564). Concordance was >90% for detection of any HR-HPV and HPV16. There was no significant difference in cellular adequacy for cytological testing between SCA and CCA, (p = 0.162). Concordance for cytologic prediction was 88.2% for any cytologic abnormality. Almost half (48.5%) of participants expressed no preference for SCA versus CCA; 15.2% preferred SCA and 35.4% CCA.

CONCLUSIONS

SCA may be an acceptable and feasible alternative to CCA for detecting HPV and cytological abnormalities in a clinic population.

摘要

背景

某些人群患肛门癌的风险较高,筛查需要采集肛门拭子进行人乳头瘤病毒(HPV)DNA检测和/或细胞学检测。然而,存在一些障碍,比如需要进行私密检查,以及围绕艾滋病毒感染状况、性取向和性行为的污名化问题。自我采集肛门拭子(SCA)是一种提议的替代临床医生采集拭子(CCA)的方法,以克服这些障碍。

方法

参与者被顺序随机分组,先进行自我采集肛门拭子或临床医生采集拭子,随后立即采集第二次拭子。评估用于HPV DNA检测和细胞学检测的样本充足性。以临床医生采集拭子作为金标准,计算自我采集肛门拭子在细胞学和HPV检测结果方面的敏感性和特异性。在操作完成后评估拭子采集的可接受性。

结果

自我采集肛门拭子和临床医生采集拭子在HPV DNA检测的样本有效性方面无显著差异(p = 0.564)。在检测任何高危型HPV和HPV16方面,一致性>90%。自我采集肛门拭子和临床医生采集拭子在细胞学检测的细胞充足性方面无显著差异(p = 0.162)。对于任何细胞学异常,细胞学预测的一致性为88.2%。几乎一半(48.5%)的参与者表示对自我采集肛门拭子和临床医生采集拭子没有偏好;15.2%的人更喜欢自我采集肛门拭子,35.4%的人更喜欢临床医生采集拭子。

结论

对于在临床人群中检测HPV和细胞学异常,自我采集肛门拭子可能是临床医生采集拭子的一种可接受且可行的替代方法。

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本文引用的文献

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International Anal Neoplasia Society's consensus guidelines for anal cancer screening.国际肛门肿瘤学会肛门癌筛查共识指南。
Int J Cancer. 2024 May 15;154(10):1694-1702. doi: 10.1002/ijc.34850. Epub 2024 Jan 31.
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Acceptability of Anal Human Papillomavirus Home Self-Sampling and Clinician Sampling Among Sexual and Gender Minority Individuals in Milwaukee, Wisconsin: The Prevent Anal Cancer Self-Swab Study.接受度分析人类乳头瘤病毒在家自采样和临床医生采样之间在密尔沃基,威斯康星州的性和性别少数群体:预防肛门癌自我拭子研究。
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Home-based self-sampling vs clinician sampling for anal precancer screening: The Prevent Anal Cancer Self-Swab Study.家庭自我采样与临床医生采样用于肛门癌前病变筛查:预防肛门癌自我拭子研究。
Int J Cancer. 2023 Aug 15;153(4):843-853. doi: 10.1002/ijc.34553. Epub 2023 May 9.
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Distribution of HPV Subtypes in Diverse Anogenital and Oral Samples from Women and Correlation of Infections with Neoplasia of the Cervix.女性不同肛门生殖器及口腔样本中HPV亚型的分布及其感染与子宫颈肿瘤形成的相关性
Cancers (Basel). 2022 Jun 26;14(13):3136. doi: 10.3390/cancers14133136.
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Treatment of Anal High-Grade Squamous Intraepithelial Lesions to Prevent Anal Cancer.治疗肛门高级别鳞状上皮内病变以预防肛门癌。
N Engl J Med. 2022 Jun 16;386(24):2273-2282. doi: 10.1056/NEJMoa2201048.
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Self-collected and clinician-collected anal swabs show modest agreement for HPV genotyping.自我采集和临床医生采集的肛门拭子在 HPV 基因分型方面显示出适度的一致性。
PLoS One. 2021 Apr 26;16(4):e0250426. doi: 10.1371/journal.pone.0250426. eCollection 2021.
7
Ambulatory anal self-sampling in MSM living with HIV, an acceptable and reliable screening method.男男性行为者(MSM)HIV 感染者门诊肛门自我采样,一种可接受且可靠的筛查方法。
PLoS One. 2021 Feb 9;16(2):e0246338. doi: 10.1371/journal.pone.0246338. eCollection 2021.
8
A meta-analysis of anal cancer incidence by risk group: Toward a unified anal cancer risk scale.一项按风险组分析肛门癌发病率的荟萃分析:建立统一的肛门癌风险量表。
Int J Cancer. 2021 Jan 1;148(1):38-47. doi: 10.1002/ijc.33185. Epub 2020 Jul 29.
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Risk of vulvar, vaginal and anal high-grade intraepithelial neoplasia and cancer according to cervical human papillomavirus (HPV) status: A population-based prospective cohort study.根据宫颈人乳头瘤病毒(HPV)状况,外阴、阴道和肛门高级别上皮内瘤变和癌症的风险:一项基于人群的前瞻性队列研究。
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