Mass Screening Registry of the Finnish Cancer Registry, Pieni Roobertinkatu 9, FIN-00130 Helsinki, Finland.
BMJ. 2010 Apr 27;340:c1804. doi: 10.1136/bmj.c1804.
To assess the performance and impact of primary human papillomavirus (HPV) DNA screening with cytology triage compared with conventional cytology on cervical cancer and severe pre-cancerous lesions.
Randomised trial.
Population based screening programme for cervical cancer in southern Finland in 2003-5.
58 076 women, aged 30-60, invited to the routine population based screening programme for cervical cancer.
Primary HPV DNA test (hybrid capture II) with cytology triage if the result was positive or conventional cytological screening (reference).
Rate of cervical cancer, cervical intraepithelial neoplasia (CIN) grade III, and adenocarcinoma in situ (as a composite outcome referred to as CIN III+) during 2003-7 through record linkage between files from the screening registry and the national cancer registry.
In the HPV and conventional arms there were 95 600 and 95 700 woman years of follow-up and 76 and 53 cases of CIN III+, respectively (of which six and eight were cervical cancers). The relative rate of CIN III+ in the HPV arm versus the conventional arm was 1.44 (95% confidence interval 1.01 to 2.05) among all women invited for screening and 1.77 (1.16 to 2.74) among those who attended. Among women with a normal or negative test result, the relative rate of subsequent CIN III+ was 0.28 (0.04 to 1.17). The rate of cervical cancer between arms was 0.75 (0.25 to 2.16) among women invited for screening and 1.98 (0.52 to 9.38) among those who attended.
When incorporated into a well established organised screening programme, primary HPV screening with cytology triage was more sensitive than conventional cytology in detecting CIN III+ lesions. The number of cases of cervical cancer was small, but considering the high probability of progression of CIN III the findings are of importance regarding cancer prevention.
Current Controlled Trials ISRCTN23885553.
评估与传统细胞学筛查相比，以细胞学分流为基础的原发性人乳头瘤病毒（HPV）DNA 筛查在宫颈癌和重度癌前病变中的表现和影响。
随机试验。
2003-2005 年芬兰南部基于人群的宫颈癌筛查计划。
58076 名年龄在 30-60 岁之间的妇女，受邀参加常规基于人群的宫颈癌筛查计划。
以细胞学分流为基础的原发性 HPV DNA 检测（杂交捕获 II），如果结果阳性，则进行传统细胞学筛查（参考）。
2003-2007 年通过筛查登记处和国家癌症登记处的文件记录链接，记录宫颈癌、宫颈上皮内瘤变（CIN）III 级和原位腺癌（作为一个复合结局，称为 CIN III+）的发生率。
在 HPV 和传统组中，分别有 95600 和 95700 名妇女进行了随访，分别有 76 例和 53 例发生 CIN III+（其中 6 例和 8 例为宫颈癌）。与传统组相比，所有受邀筛查的妇女中 HPV 组的 CIN III+相对发生率为 1.44（95%置信区间 1.01 至 2.05），实际参加筛查的妇女为 1.77（1.16 至 2.74）。在检测结果正常或阴性的妇女中，随后发生 CIN III+的相对发生率为 0.28（0.04 至 1.17）。两组中宫颈癌的发生率在受邀筛查的妇女中为 0.75（0.25 至 2.16），在实际参加筛查的妇女中为 1.98（0.52 至 9.38）。
当纳入一个成熟的有组织的筛查计划时，以细胞学分流为基础的原发性 HPV 筛查比传统细胞学筛查在检测 CIN III+病变方面更敏感。宫颈癌的病例数较少，但鉴于 CIN III 的高进展概率，这些发现对癌症预防具有重要意义。
当前对照试验 ISRCTN23885553。
