中国人群HPV感染自然史及传播风险的前瞻性队列研究

项目名称： 中国人群HPV感染自然史及传播风险的前瞻性队列研究

项目编号： No.81473033

项目类型： 面上项目

立项/批准年度： 2015

项目学科： 医药、卫生

项目作者： 何忠虎

作者单位： 北京大学

项目金额： 70万元

中文摘要： 人乳头状瘤病毒（HPV）感染为女性宫颈癌发生必要条件。男性HPV感染对女性HPV感染存在确切影响。HPV疫苗干预可显著降低宫颈病变发病率，但因缺乏可靠的男性HPV感染自然史及异性间HPV传播数据，是否应对男性进行疫苗干预争议较大。我国HPV疫苗项目尚处评估阶段，亟需来自我国自然人群的HPV感染自然史及传播的基础数据，以制定符合中国人群特点且经济有效的HPV免疫预防策略。本研究拟利用本课题组已经建立的大规模自然人群队列，对超过2000人及其中800余对健康夫妻进行生殖器HPV感染状态以6个月为间隔共计6个断面的前瞻性随访。采用PCR及测序技术对生殖器脱落细胞标本进行HPV DNA检测与分型。利用GEE等统计模型进行纵向数据分析，回答我国自然人群男、女性生殖器HPV感染获得-持续-清除等自然史及男、女性间HPV传播基本规律等重要科学问题，为HPV相关肿瘤防控策略制定提供基础数据及科学证据。

中文关键词： 人乳头状瘤病毒；队列研究；自然史；性传播；中国

英文摘要： Human Papilloma Virus (HPV) infection is a necessary cause for cervical cancer in women. In recent decades, HPV infection in men has also brought about increasing concern due to its direct impact on women. HPV vaccination intervention has been proved to be able to decrease the incidence of cervical lesions. But whether this prophylactic program should also be conducted in men is still being controversial due to the lack of reliable data of natural history of HPV infection in men. HPV vaccination program is still in the clinical evaluation stage in China and basic data of natural history of HPV infection from Chinese population is desperately needed to form a cost-effective strategy which is suitable to the China situation. In this study, we will enroll and follow up over 2000 participants (>800 healthy couples) bi-anally for up to 7 visits on the basis of an ongoing large population-based cohort that established by our research group. PCR and sequencing method would be used for detection and genotyping of HPV DNA in the genital exfoliated cells specimens. GEE model would be constructed to answer a series of crucial scientific questions including the natural history of HPV infection in natural population of China, i.e.acquisition, duration and clearance, and the transmission model between husbands and wives. Results from this study will provide essential basic data and scientific evidence on formation of the prophylactic strategy of HPV related cancers in China.

英文关键词： Human Papilloma Virus;Cohort Study;Natural History;Sexual Transmission;China