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人乳头瘤病毒疫苗对肛门人乳头瘤病毒感染、肛门上皮内瘤变和肛门上皮内瘤变复发影响的系统评价和荟萃分析。

Impact of Human Papillomavirus Vaccine Against Anal Human Papillomavirus Infection, Anal Intraepithelial Neoplasia, and Recurrence of Anal Intraepithelial Neoplasia: A Systematic Review and Meta-analysis.

机构信息

Early Detection, Prevention and Infections Branch, International Agency for Research on Cancer (IARC/WHO), Lyon, France.

Department of Infectious Diseases, Public Health Service Amsterdam, Amsterdam, the  Netherlands.

出版信息

J Infect Dis. 2023 Nov 28;228(11):1496-1504. doi: 10.1093/infdis/jiad183.

Abstract

BACKGROUND

We sought to summarize human papillomavirus (HPV) vaccine efficacy/effectiveness (VE) against anal HPV infection and anal intraepithelial neoplasia (AIN).

METHODS

We performed literature review and meta-analysis to estimate VE, stratified by age and analytic population (per-protocol efficacy [PPE] or intention-to-treat [ITT] population in clinical trials, or all participants in real-world studies).

RESULTS

We identified 6 clinical trials and 8 real-world studies. In participants vaccinated at age ≤26 years (mainly human immunodeficiency virus [HIV]-negative individuals), significant VE against incident/prevalent anal HPV infection was reported in clinical trials, with a higher estimate in PPE (2 studies with 2390 participants; VE, 84% [95% confidence interval (CI), 77%-90%]; I2 = 0%) than ITT (2 studies with 4885 participants; 55%, 39%-67%; I2 = 46%) populations or in real-world studies (4 studies with 2375 participants; 77%, 40%-91%; I2 = 81%). HPV vaccination at age ≤26 years was associated with significant VE in preventing persistent anal HPV infection and AIN. No significant VE against anal HPV infection or AIN was found in persons vaccinated at age >26 years (mainly people living with HIV).

CONCLUSIONS

There is strong evidence for high VE against anal HPV infection and AIN in HIV-negative individuals vaccinated at age ≤26 years. However, the lower impact in ITT than in PPE populations and the lack of significant effect in people living with HIV aged >26 years indicates that vaccines have the higher impact in populations with less sexual exposure to anal HPV.

摘要

背景

我们旨在总结人乳头瘤病毒(HPV)疫苗对肛门 HPV 感染和肛门上皮内瘤变(AIN)的疗效/效果(VE)。

方法

我们进行了文献回顾和荟萃分析,以估计 VE,按年龄和分析人群分层(临床试验中的协议疗效[PPE]或意向治疗[ITT]人群,或真实世界研究中的所有参与者)。

结果

我们确定了 6 项临床试验和 8 项真实世界研究。在接种疫苗年龄≤26 岁的参与者中(主要为人类免疫缺陷病毒[HIV]阴性个体),临床试验报告了针对新发/现患肛门 HPV 感染的显著 VE,PPE 中的估计值更高(2 项研究共 2390 名参与者;VE,84%[95%置信区间[CI],77%-90%];I2=0%),高于 ITT(2 项研究共 4885 名参与者;55%,39%-67%;I2=46%)人群或真实世界研究(4 项研究共 2375 名参与者;77%,40%-91%;I2=81%)。在≤26 岁接种 HPV 疫苗与预防持续性肛门 HPV 感染和 AIN 显著相关。在>26 岁接种疫苗的人群中,未发现对肛门 HPV 感染或 AIN 有显著的 VE(主要为 HIV 感染者)。

结论

在≤26 岁接种疫苗的 HIV 阴性个体中,有强有力的证据表明对肛门 HPV 感染和 AIN 有高度的 VE。然而,ITT 中的影响低于 PPE 人群,以及>26 岁的 HIV 感染者中没有显著效果,表明疫苗在性暴露于肛门 HPV 较少的人群中具有更高的影响。

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