Ceska Gynekol. 2020 Winter;85(6):368-374.
The study evaluates results of 2-years follow-up of patients in ages 35-36 and 45-46, who are participating in the project LIBUSE, that deals with efficacy of HPV DNA and Pap smear co-testing and p16/Ki67 dual staining in the Czech national cervical screening.
Prospective observational study.
Department of Obstetrics and Gynecology, General University Hospital and 1st Medical Faculty, Charles University, Prague.
Out of all women enrolled in the project LIBUSE only those who were at the beginning of the study 35-36 and 45-46 years old were sellected. Conventional Pap smear and HPV DNA test (Cobas 4800, Roche Diagnostics) had been collected at the baseline. Women were stratified according to their results in the three risk groups: 1. low-risk, 2. high-risk and 3. intermediate risk, who subsequently underwent p16/Ki67 dual staining. All high-risk patients and those with positive result of dual staing were refered to the expert colposcopy. The cases with biopsy proven precancers or cancers were considered as „positive findings“.
Altogether 352 women meet the age requirements. In 26 (7.6%) women had been proven HPV DNA positivity and out of the them 9 cases were HPV 16/18 positive. Severe cytological abnormality was found only in one patient (0.3%), who was simultaneously HPV positive. Ten women (2.8%) were classified as high-risk and directly refered to colposcopy. Another 18 patients underwent p16/Ki67 dual staining and 4 positive cases were refered to colposcopy too. After one year further 9 patients were classified as intermediate risk and 6 more were identified after two years of follow-up. Within two years 9 more patient were refered to colposcopy. After the entire period of follow-up in 10 patients biopsy confirmed precancer lesions, none of them had invasive cancer.
Addition of HPV DNA testing with selective HPV 16/18 genotyping to the cytology based screening significantly increases sensitivity and safety of our cervical screening program.
本研究评估了参加捷克国家宫颈癌筛查项目 LIBUSE 的 35-36 岁和 45-46 岁患者的 2 年随访结果，该项目评估了 HPV DNA 和巴氏涂片联合检测以及 p16/Ki67 双重染色在宫颈癌筛查中的效果。
前瞻性观察性研究。
布拉格查理大学第一医学院和综合大学附属医院妇产科。
从参加 LIBUSE 项目的所有女性中，仅选择研究开始时年龄为 35-36 岁和 45-46 岁的女性。在基线时采集常规巴氏涂片和 HPV DNA 检测（Cobas 4800，罗氏诊断）。根据她们在三个风险组中的结果对女性进行分层：1. 低危，2. 高危和 3. 中危，随后对这些女性进行 p16/Ki67 双重染色。所有高危患者和双重染色阳性的患者均转诊至专家阴道镜检查。活检证实为癌前病变或癌症的病例被视为“阳性发现”。
共有 352 名女性符合年龄要求。其中 26 名（7.6%）女性 HPV DNA 检测呈阳性，其中 9 名患者 HPV 16/18 阳性。仅一名患者（0.3%）同时 HPV 阳性，发现严重细胞学异常。10 名（2.8%）女性被归类为高危，直接转诊至阴道镜检查。另有 18 名患者进行了 p16/Ki67 双重染色，其中 4 例阳性病例也转诊至阴道镜检查。一年后，9 名患者被归类为中危，两年后又有 6 名患者被归类为中危。两年内，又有 9 名患者被转诊至阴道镜检查。在整个随访期间，10 名患者的活检证实存在癌前病变，无一例为浸润性癌。
在细胞学为基础的筛查中增加 HPV DNA 检测并选择性进行 HPV 16/18 基因分型可显著提高我们宫颈癌筛查计划的敏感性和安全性。
