我国上市人乳头瘤病毒疫苗接种及安全性研究

doi:10.19803/j.1672-8629.20211075

摘要/Abstract

摘要： 目的分析我国上市人乳头瘤病毒（HPV）疫苗接种信息,为HPV疫苗接种安全提供参考。方法基于上市HPV疫苗类型、接种执行现状、疫苗的安全性研究3个方面展开论述,重点讨论有关接种安全性监测与分析的开展情况,并提出针对性意见和建议。结果我国上市HPV疫苗有二价（进口、国产各1种）、四价（进口）和九价（进口）,且接种覆盖率逐年提升。疫苗接种的安全性反馈主要以主动监测、被动监测和观察性研究3种方式进行。结论上市HPV疫苗的安全性评价对改善疫苗安全性、提高疫苗覆盖率意义重大,更为深入的分析研究亟需加强。

关键词: 人乳头瘤病毒（HPV）, 宫颈癌, 疫苗, 安全性, 不良事件

Abstract: Objective To review the inoculation information of licensed human papilloma virus (HPV) vaccines in China, so as to provide reference for the safety of HPV vaccine inoculation. Methods We did a systemic discussion based on the types of vaccine, the status quo of inoculation, and the safety studies of the licensed vaccines in China. Focus on the development of surveillance and research for the safety of vaccination, and then put forward targeted opinions and suggestions for future HPV prevention. Results Four HPV vaccines (i.e., Cervarix, Gardasil, Gardasil 9, and Cecolin) have been licensed in China, and their vaccination coverage rates are increasing year by year. The feedback of vaccination safety was mainly from three measures: active surveillance, passive surveillance, and observational studies. Conclusion The safety evaluation for licensed HPV vaccines has great significance to improve inoculation safety and increase vaccination coverage rate. The existing safety studies are still stay in data statistical processing, more in-depth analytical methods and researches need to be implemented.

Key words: human papilloma virus (HPV), cervical cancer, vaccine, safety, adverse event

中图分类号:

资文瑞, 杨秋月, 苏俊, 谢江安. 我国上市人乳头瘤病毒疫苗接种及安全性研究[J]. 中国药物警戒, 2023, 20(3): 311-316.

ZI Wenrui, YANG Qiuyue, SU Jun, XIE Jiang'an. The research development of inoculation safety associated with licensed HPV vaccines in China[J]. Chinese Journal of Pharmacovigilance, 2023, 20(3): 311-316.

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