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人乳头瘤病毒疫苗的安全性:最新综述。

Safety of Human Papillomavirus Vaccines: An Updated Review.

机构信息

The University of Sydney, Sydney, NSW, Australia.

National Centre for Immunisation Research and Surveillance, Kids Research Institute, The Sydney Children's Hospitals Network, Cnr Hawkesbury Road and Hainsworth Street, Westmead, NSW, 2145, Australia.

出版信息

Drug Saf. 2018 Apr;41(4):329-346. doi: 10.1007/s40264-017-0625-z.


DOI:10.1007/s40264-017-0625-z
PMID:29280070
Abstract

Human papillomavirus (HPV) vaccines are now included in immunisation programmes in 71 countries. Unfortunately, uptake has been impacted in some countries by reduced confidence in the safety of the HPV vaccine. In 2013, we published an extensive review demonstrating a reassuring safety profile for bivalent (2vHPV) and quadrivalent (4vHPV) vaccines. A nonavalent (9vHPV) vaccine is now available and HPV immunisation programmes have been extended to males in 11 countries. The aim of this updated narrative review was to examine the evidence on HPV vaccine safety, focusing on the 9vHPV vaccine, special populations and adverse events of special interest (AESI). The previous searches were replicated to identify studies to August 2016, including additional search terms for AESI. We identified 109 studies, including 15 population-based studies in over 2.5 million vaccinated individuals across six countries. All vaccines demonstrated an acceptable safety profile; injection-site reactions were slightly more common for 9vHPV vaccine than for 4vHPV vaccine. There was no consistent evidence of an increased risk of any AESI, including demyelinating syndromes or neurological conditions such as complex regional pain or postural orthostatic tachycardia syndromes. The risk-benefit profile for HPV vaccines remains highly favourable.

摘要

人乳头瘤病毒(HPV)疫苗现已纳入 71 个国家的免疫计划。不幸的是,由于对 HPV 疫苗安全性的信心降低,一些国家的疫苗接种率受到了影响。2013 年,我们发表了一篇广泛的综述,证明了二价(2vHPV)和四价(4vHPV)疫苗具有令人安心的安全性。目前已有九价(9vHPV)疫苗上市,11 个国家已将 HPV 免疫接种计划扩展至男性。本更新叙述性综述的目的是检查 HPV 疫苗安全性方面的证据,重点关注九价 HPV 疫苗、特殊人群和特殊关注的不良事件(AESI)。复制了之前的搜索以确定截至 2016 年 8 月的研究,包括 AESI 的附加搜索词。我们确定了 109 项研究,其中包括来自六个国家的超过 250 万接种个体的 15 项基于人群的研究。所有疫苗均表现出可接受的安全性;九价 HPV 疫苗比四价 HPV 疫苗更常出现注射部位反应。没有一致证据表明 AESI 的风险增加,包括脱髓鞘综合征或神经疾病,如复杂区域疼痛或姿势性心动过速综合征。HPV 疫苗的风险效益比仍然非常有利。

相似文献

[1]
Safety of Human Papillomavirus Vaccines: An Updated Review.

Drug Saf. 2018-4

[2]
Immunogenicity and safety of a mixed vaccination schedule with one dose of nonavalent and one dose of bivalent HPV vaccine versus two doses of nonavalent vaccine - A randomized clinical trial.

Vaccine. 2018-10-9

[3]
A Randomized, Double-Blind, Phase III Study of the Immunogenicity and Safety of a 9-Valent Human Papillomavirus L1 Virus-Like Particle Vaccine (V503) Versus Gardasil® in 9-15-Year-Old Girls.

Pediatr Infect Dis J. 2015-9

[4]
Use of 9-valent human papillomavirus (HPV) vaccine: updated HPV vaccination recommendations of the advisory committee on immunization practices.

MMWR Morb Mortal Wkly Rep. 2015-3-27

[5]
Adverse events following HPV vaccination: 11 years of surveillance in Australia.

Vaccine. 2020-8-27

[6]
Overview of the benefits and potential issues of the nonavalent HPV vaccine.

Int J Gynaecol Obstet. 2017-3

[7]
Safety profile of the 9-valent human papillomavirus vaccine: assessment in prior quadrivalent HPV vaccine recipients and in men 16 to 26 years of age.

Hum Vaccin Immunother. 2017-12-14

[8]
The comparative safety of human papillomavirus vaccines: A Bayesian network meta-analysis.

J Med Virol. 2022-2

[9]
Post-licensure safety monitoring of quadrivalent human papillomavirus vaccine in the Vaccine Adverse Event Reporting System (VAERS), 2009-2015.

Vaccine. 2018-2-21

[10]
Prophylactic human papillomavirus vaccination and primary prevention of cervical cancer: issues and challenges.

Clin Microbiol Infect. 2012-8-6

引用本文的文献

[1]
HPV Vaccines - An Overview.

Indian J Dermatol. 2025

[2]
Overcoming HPV Vaccine Hesitancy in Japan: A Narrative Review of Safety Evidence, Risk Communication, and Policy Approaches.

Vaccines (Basel). 2025-5-30

[3]
Intervention Strategies to Overcome HPV Vaccine Hesitancy Among Hispanic Immigrants in the USA: A Video-Based Approach.

Vaccines (Basel). 2025-5-28

[4]
Pharmacovigilance analysis of spondyloarthritis following HPV vaccination based on the VAERS database.

Sci Rep. 2025-6-6

[5]
Adolescent Attitudes Toward the Human Papillomavirus (HPV) Vaccine in Kocaeli, Turkiye.

Cureus. 2025-2-9

[6]
Prophylactic vaccines against HPV-caused cervical cancer: novel vaccines are still demanded.

Infect Agent Cancer. 2025-3-10

[7]
Prophylactic HPV vaccination in HPV-related gynecologic cancers: European Society of Gynecological Oncology (ESGO) prevention committee opinion.

Int J Gynaecol Obstet. 2025-5

[8]
Investigating the Potential Short-term Adverse Effects of the Quadrivalent Human Papillomavirus Vaccine: A Novel Regression Discontinuity Analysis.

Epidemiology. 2024-11-1

[9]
A Review of Human Papillomavirus Vaccination and Associated Ethical Concerns.

Infect Chemother. 2024-12

[10]
Safety profile assessment of HPV4 and HPV9 vaccines through the passive surveillance system of the Veneto Region (Italy) between 2008 and 2022: A 15-year retrospective observational study.

Vaccine X. 2024-6-21

本文引用的文献

[1]
Evidence Refuting the Existence of Autoimmune/Autoinflammatory Syndrome Induced by Adjuvants (ASIA).

J Allergy Clin Immunol Pract. 2017-9-6

[2]
Human papillomavirus vaccination and risk of autoimmune diseases: A large cohort study of over 2million young girls in France.

Vaccine. 2017-8-24

[3]
Suspected Adverse Effects After Human Papillomavirus Vaccination: A Temporal Relationship Between Vaccine Administration and the Appearance of Symptoms in Japan.

Drug Saf. 2017-12

[4]
Meeting of the Global Advisory Committee on Vaccine Safety, 7–8 June 2017.

Wkly Epidemiol Rec. 2017-7-14

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Human papillomavirus vaccines: WHO position paper, May 2017.

Wkly Epidemiol Rec. 2017-5-12

[6]
Quadrivalent HPV Vaccination and the Risk of Adverse Pregnancy Outcomes.

N Engl J Med. 2017-3-30

[7]
No increased risk of Guillain-Barré syndrome after human papilloma virus vaccine: A self-controlled case-series study in England.

Vaccine. 2017-3-23

[8]
Risk of autoimmune diseases and human papilloma virus (HPV) vaccines: Six years of case-referent surveillance.

J Autoimmun. 2017-2-9

[9]
Current Safety Concerns with Human Papillomavirus Vaccine: A Cluster Analysis of Reports in VigiBase.

Drug Saf. 2017-1

[10]
Social mobilisation, consent and acceptability: a review of human papillomavirus vaccination procedures in low and middle-income countries.

BMC Public Health. 2016-8-19

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