Maggino Tiziano, Sciarrone Rocco, Murer Bruno, Dei Rossi Maria Rosa, Fedato Chiara, Maran Michela, Lorio Melania, Soldà Marika, Zago Fiorella, Giorgi Rossi Paolo, Zorzi Manuel
Azienda ULSS 12 Veneziana, Obstetrics and Gynaecology Unit, Dell'Angelo Hospital, Via Paccagnella 11, Mestre 30174 (VE), Italy.
Azienda ULSS 16 Padova, Department of Prevention, Via Ospedale Civile 22, Padua 35100, Italy.
Br J Cancer. 2016 Aug 23;115(5):525-32. doi: 10.1038/bjc.2016.216. Epub 2016 Aug 4.
HPV DNA-based screening is more effective than a Pap test in preventing cervical cancer, but the test is less specific. New HPV tests have been proposed for primary screening. The HPV mRNA test showed a similar or slightly lower sensitivity than the HPV DNA tests but with a higher specificity. We report the results of an organised HPV mRNA-based screening pilot program in Venice, Italy.
From October 2011 to May 2014, women aged 25-64 years were invited to undergo a HPV mRNA test (Aptima). Those testing positive underwent cytological triage. Women with positive cytology were referred to colposcopy, whereas those with negative cytology were referred to repeat the HPV mRNA test 1 year later. The results of the HPV mRNA test program were compared with both the local historical cytology-based program and with four neighbouring DNA HPV-based pilot projects.
Overall, 23 211 women underwent a HPV mRNA test. The age-standardised positivity rate was 7.0%, higher than in HPV DNA programs (6.8%; relative rate (RR) 1.11, 95% confidence interval (CI) 1.05-1.17). The total colposcopy referral was 5.1%, double than with cytology (2.6%; RR 2.02, 95% CI 1.82-2.25) but similar to the HPV DNA programs (4.8%; RR 1.02; 95% CI 0.96-1.08). The cervical intraepithelial neoplasia grade 2+ detection rate with HPV mRNA was greater than in the HPV DNA programs at baseline (RR 1.50; 95% CI 1.19-1.88) and not significantly lower at the 1-year repeat (RR 0.70; 95% CI 0.40-1.16). The overall RR was 1.29 (95% CI 1.05-1.59), which was much higher than with cytology (detection rate 5.5‰ vs 2.1‰; RR 2.50, 95% CI 1.76-3.62).
A screening programme based on the HPV mRNA obtained results similar to those observed with the HPV DNA test. In routine screening programmes, even a limited increase in HPV prevalence may conceal the advantage represented by the higher specificity of HPV mRNA.
基于人乳头瘤病毒（HPV）DNA的筛查在预防宫颈癌方面比巴氏试验更有效，但该检测特异性较低。已提出新的HPV检测用于初筛。HPV mRNA检测显示出与HPV DNA检测相似或略低的敏感性，但特异性更高。我们报告了在意大利威尼斯开展的一项基于HPV mRNA的有组织筛查试点项目的结果。
2011年10月至2014年5月，邀请25 - 64岁的女性接受HPV mRNA检测（Aptima）。检测呈阳性者接受细胞学分流。细胞学检查呈阳性的女性被转诊至阴道镜检查，而细胞学检查呈阴性的女性被转诊在1年后重复进行HPV mRNA检测。将HPV mRNA检测项目的结果与当地基于历史细胞学的项目以及四个相邻的基于HPV DNA的试点项目进行比较。
总体而言，23211名女性接受了HPV mRNA检测。年龄标准化阳性率为7.0%，高于HPV DNA检测项目（6.8%；相对率（RR）1.11，95%置信区间（CI）1.05 - 1.17）。阴道镜检查转诊总数为5.1%，是细胞学检查的两倍（2.6%；RR 2.02，95% CI 1.82 - 2.25），但与HPV DNA检测项目相似（4.8%；RR 1.02；95% CI 0.96 - 1.08）。HPV mRNA检测在基线时检测到的2级及以上宫颈上皮内瘤变的发生率高于HPV DNA检测项目（RR 1.50；95% CI 1.19 - 1.88），在1年重复检测时也未显著降低（RR 0.70；95% CI 0.40 - 1.16）。总体RR为1.29（95% CI 1.05 - 1.59），远高于细胞学检查（检测率5.5‰对2.1‰；RR 2.50，95% CI 1.76 - 3.62）。
基于HPV mRNA的筛查项目所获结果与HPV DNA检测观察到的结果相似。在常规筛查项目中，即使HPV患病率有有限增加，也可能掩盖HPV mRNA更高特异性所代表的优势。
