摘要
预防性人乳头瘤病毒(human papillomavirus,HPV)疫苗接种率低阻碍全球实现宫颈癌消除目标。单剂次HPV疫苗接种程序具有降低疫苗成本和简化接种流程等优势,有望在短时间内提高接种覆盖率。本文对全球单剂次HPV疫苗临床评估和成本效益研究进展作综述,为疫苗接种方案的优化提供依据。结果显示,年轻女性接种单剂次HPV疫苗的临床有效性、免疫原性和安全性已在临床试验和真实世界研究中得到广泛认同,部分研究的随访时间长达10~16年;有几项研究也初步证实男性人群和人类免疫缺陷病毒(human immunodeficiency virus,HIV)感染人群接种单剂次HPV疫苗的获益;模型研究显示单剂次程序即使在保守估计效力的接种情境下仍具有良好的成本效益。在基于上述证据发布的世界卫生组织指南的推荐下,全球68个不同收入水平的国家已将单剂次接种程序纳入免疫规划。然而,目前我国已上市的5种HPV疫苗在中国本土人群中的单剂次实证研究证据仍有待积累,尤其是国产疫苗和长期监测数据,以促进单剂次程序在中国人群的推广应用。
The low vaccination rates of preventive human papillomavirus(HPV)vaccines hinder global efforts to eliminate cervical cancer.The single-dose HPV vaccination regimen offers advantages such as reduced vaccine costs and simplified vaccination processes,which may significantly enhance coverage in a short period.This re-view summarizes the global clinical evaluations and cost-effectiveness studies of single-dose HPV vaccines,pro-viding a basis for optimizing vaccination strategies.Results indicate that the clinical efficacy,immunogenicity,and safety of single-dose HPV vaccination in young women have been widely recognized in clinical trials and real-world studies,with some studies reporting follow-up periods of up to 10-16 years.Preliminary evidence also sup-ports the benefits of single-dose HPV vaccination in male populations and individuals infected with the human im-munodeficiency virus(HIV).Modeling studies show that even under conservative estimates of efficacy,the single-dose regimen demonstrated good cost-effectiveness.Following the recommendations from the World Health Organization based on the above evidence,68 countries across different income levels have incorporated the single-dose vaccination program into their national immunization programs.However,empirical research on the single-dose efficacy of the five HPV vaccines currently available in China remains limited,particularly regarding domestic vaccines and long-term monitoring data,which are essential for promoting the implementation of this regimen in the Chinese population.
作者
文天萌
洪昱廷
潘程浩
胡尚英
赵方辉
WEN Tianmeng;HONG Yuting;PAN Chenghao;HU Shangying;ZHAO Fanghui(Department of Epidemiology,National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100021,China)
出处
《中国病毒病杂志》
2025年第3期236-243,共8页
Chinese Journal of Viral Diseases
基金
国家自然科学基金(82273723)
美国中华医学基金会公开竞标项目(CMB-OC#21-420)
比尔梅琳达盖茨基金会项目(INV-031449)。
关键词
子宫颈癌
HPV疫苗
单剂次
临床评估
成本效益
研究进展
Cervical cancer
HPV vaccines
Single-dose
Clinical evaluation
Cost-effectiveness
Research progress
