Klinikum der Stadt Wolfsburg, Germany.
J Clin Virol. 2009 Nov;46 Suppl 3:S5-10. doi: 10.1016/S1386-6532(09)70294-X.
Currently, the German cervical cancer screening program encompasses an annual cytological Papanicolaou (Pap) smear. However, primary screening for cervical cancer using human papillomavirus (HPV) DNA testing detects cervical pre-cancerous lesions with a significantly higher sensitivity than the Pap smear-based cytology.
In order to develop viable modalities for primary cervical screening incorporating DNA testing for high-risk (HR) types of HPV, we started a pilot project in the city of Wolfsburg, Germany, in February 2006. This program provided a risk-adapted HPV testing-based strategy with defined patient pathways and extended screening intervals for women of 30 years or older. We report here the data of a 3-year follow-up.
In the context of the usual routine screening at their office-based gynecologists, women were offered conventional cytology plus the Hybrid Capture 2 (HC2) HPV DNA test. Women with inconspicuous cytological findings (Pap I/II) and negative HC2 test were re-tested after 5 years but continued their annual gynecological examinations. When cytology and HC2 were positive, women were immediately referred to colposcopy. In women with a negative cytology but positive HC2 test, Pap smear was repeated after 6 mo and HC2 testing after 12 mo, and women were called for colposcopy if the HC2 test was persistently positive.
From February 2006 to December 2008, 16,724 women agreed to participate in the project. Overall, 906 (5.41%) had positive HC2 results and 338 (2.02%) showed atypical Pap smears at recruitment. There were 417 (2.48%) women referred for colposcopy, 104 of whom were diagnosed with cervical intraepithelial neoplasia (CIN) 3 or worse, including 8 invasive cancers and 8 adenocarcinoma in situ (ACIS). No case of CIN 3 or worse occurred in HC2 negative women.
The presented risk-adapted Wolfsburg Cervical Cancer Prevention Project ("Wolfsburg Model") has been shown to be effective and feasible in identifying women at risk and for avoiding unnecessary procedures for those who are double negative, thus allowing longer screening intervals and cost savings. Acceptance rates for the program were high for both participating women and gynecologists.
目前，德国的宫颈癌筛查项目包括每年进行巴氏涂片细胞学检查。然而，与基于巴氏涂片细胞学检查的方法相比，利用人乳头瘤病毒（HPV）DNA 检测进行宫颈癌的初次筛查可以显著提高宫颈癌前病变的检出率。
为了开发可行的整合 HPV 高危型（HR）DNA 检测的宫颈癌初次筛查方法，我们于 2006 年 2 月在德国沃尔夫斯堡市启动了一个试点项目。该项目提供了一种基于 HPV 检测的风险适应策略，为 30 岁及以上的女性确定了明确的患者路径和延长的筛查间隔。我们在此报告该项目为期 3 年的随访数据。
在常规的妇科医生办公室筛查中，我们为女性提供传统细胞学检查加杂交捕获 2（HC2）HPV DNA 检测。细胞学检查未见异常（巴氏涂片 I/II）且 HC2 检测阴性的女性在 5 年后再次进行检测，但仍每年进行妇科检查。当细胞学检查和 HC2 检测均为阳性时，女性立即转诊行阴道镜检查。对于细胞学检查阴性但 HC2 检测阳性的女性，在 6 个月时重复巴氏涂片检查和 12 个月时重复 HC2 检测，如果 HC2 检测持续阳性，则行阴道镜检查。
从 2006 年 2 月至 2008 年 12 月，共有 16724 名女性同意参加该项目。总体而言，906 名（5.41%）女性 HC2 检测结果阳性，338 名（2.02%）女性在入组时巴氏涂片检查结果异常。417 名（2.48%）女性转诊行阴道镜检查，其中 104 名女性被诊断为宫颈上皮内瘤变（CIN）3 级及以上病变，包括 8 例浸润性癌和 8 例原位腺癌（ACIS）。HC2 检测阴性的女性无一例发生 CIN 3 级及以上病变。
本研究中介绍的风险适应型沃尔夫斯堡宫颈癌预防项目（“沃尔夫斯堡模式”）在识别高危女性和避免对双重阴性女性进行不必要的检查方面已被证明是有效和可行的，因此可以延长筛查间隔并节省成本。该项目在参与女性和妇科医生中的接受率均较高。
