Mahoney Martin C
Department of Health Behavior, Roswell Park Cancer Institute, State University of New York at Buffalo, USA.
J Fam Pract. 2006 Nov;Suppl:10-7.
The clinical burden of disease resulting from human papillomavirus (HPV) infection is substantial and extends from genital warts to cytologic abnormalities to cervical, vaginal, and vulvar cancers and their associated precursor lesions. In addition, HPV is implicated in anal, penile, and head and neck cancers. Thus, HPV-related disease constitutes a significant burden for both men and women. Large phase 2 and 3 clinical trials with a quadrivalent preventive HPV vaccine (HPV 6/11/16/18) and phase 2 trials with a bivalent preventive HPV vaccine (HPV 16/18) have demonstrated that both products are highly efficacious in preventing type-specific HPV infections and HPV-related disease and are well tolerated. Nearly all recipients demonstrate a robust immunologic response that currently appears to be durable for 4 or more years. Immunogenicity data among girls 9 to 15 years of age were used to "bridge" efficacy data from quadrivalent HPV vaccine trials completed to date. In June 2006, the US Food and Drug Administration approved the quadrivalent HPV vaccine for use among females 9 to 26 years of age. The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices has recommended the 3-dose series for girls 11 to 12 years of age, catch-up vaccination for girls and women 13 to 26 years of age, and permissive use as early as age 9. Computer models projecting the impact of these preventive HPV vaccines predict that they will be cost-effective and beneficial to the population; the use of preventive HPV vaccines will complement continued cytologic screening programs. Trials are under way to evaluate the duration of immune response as well as efficacy among men and women 27 years of age and older. Girls and women within the targeted age ranges should be offered vaccination to achieve the disease prevention potential of these vaccines.
人乳头瘤病毒（HPV）感染所导致的疾病临床负担十分巨大，范围从生殖器疣到细胞学异常，再到宫颈癌、阴道癌和外阴癌及其相关的前驱病变。此外，HPV还与肛门癌、阴茎癌以及头颈癌有关。因此，HPV相关疾病对男性和女性而言都是一项重大负担。针对四价预防性HPV疫苗（HPV 6/11/16/18）开展的大型2期和3期临床试验，以及针对二价预防性HPV疫苗（HPV 16/18）开展的2期试验均已证明，这两种产品在预防特定类型的HPV感染和HPV相关疾病方面具有高效性，且耐受性良好。几乎所有接种者都表现出强烈的免疫反应，目前看来这种反应可持续4年或更长时间。9至15岁女孩的免疫原性数据被用于“衔接”迄今完成的四价HPV疫苗试验的疗效数据。2006年6月，美国食品药品监督管理局批准四价HPV疫苗用于9至26岁的女性。疾病控制与预防中心免疫实践咨询委员会建议，为11至12岁的女孩接种3剂疫苗系列，为13至26岁的女孩和女性进行补种，并允许早在9岁时使用。预测这些预防性HPV疫苗影响的计算机模型显示，它们将具有成本效益且对人群有益；预防性HPV疫苗的使用将补充持续的细胞学筛查计划。目前正在进行试验以评估免疫反应的持续时间以及27岁及以上男性和女性的疗效。应向目标年龄范围内的女孩和女性提供疫苗接种，以实现这些疫苗预防疾病的潜力。
