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免疫功能低下个体的黄热病疫苗安全性:系统评价与荟萃分析

Yellow fever vaccine safety in immunocompromised individuals: a systematic review and meta-analysis.

作者信息

Wigg de Araújo Lagos Letícia, de Jesus Lopes de Abreu Ariane, Caetano Rosângela, Braga José Ueleres

机构信息

Núcleo de Avaliação de Tecnologias em Saúde (NATS), Instituto Nacional de Cardiologia, Rio de Janeiro, RJ, Brazil.

Instituto de Medicina Social, Universidade do Estado do Rio de Janeiro (UERJ), Rio de Janeiro, RJ, Brazil.

出版信息

J Travel Med. 2023 Apr 5;30(2). doi: 10.1093/jtm/taac095.

DOI:10.1093/jtm/taac095
PMID:35947986
Abstract

BACKGROUND

Yellow fever (YF) is an arbovirus with variable severity, including severe forms with high mortality. The vaccination is the most effective measure to protect against the disease. Non-serious and serious adverse events have been described in immunocompromised individuals, but previous studies have failed to demonstrate this association. This systematic review assessed the risk of adverse events after YF vaccination in immunocompromised individuals compared with its use in non-immunocompromised individuals.

METHODS

A search was conducted in the MEDLINE, LILACS, EMBASE, SCOPUS, DARE, Toxiline, Web of Science and grey literature databases for publications until February 2021. Randomized and quasi-randomized clinical trials and observational studies that included immunocompromised participants (individuals with HIV infection, organ transplants, with cancer, who used immunosuppressive drugs for rheumatologic diseases and those on immunosuppressive therapy for other diseases) were selected. The methodological quality of observational or non-randomized studies was assessed by the ROBINS-I tool. Two meta-analyses were performed, proportion and risk factor analyses, to identify the summary measure of relative risk (RR) in the studies that had variables suitable for combination.

RESULTS

Twenty-five studies were included, most with risk of bias classified as critical. Thirteen studies had enough data to carry out the proposed meta-analyses. Seven studies without a comparator group had their results aggregated in the proportion meta-analysis, identifying an 8.5% [95% confidence interval (CI) 0.07-21.8] risk of immunocompromised individuals presenting adverse events after vaccination. Six cohort studies were combined, with an RR of 1.00 (95% CI 0.78-1.29). Subgroup analysis was performed according to the aetiology of immunosuppression and was also unable to identify an increased risk of adverse events following vaccination.

CONCLUSIONS

It is not possible to affirm that immunocompromised individuals, regardless of aetiology, have a higher risk of adverse events after receiving the YF vaccine.

摘要

背景

黄热病(YF)是一种虫媒病毒,病情严重程度各异,包括致死率高的严重形式。接种疫苗是预防该疾病的最有效措施。免疫功能低下个体中曾有非严重和严重不良事件的报道,但既往研究未能证实这种关联。本系统评价评估了免疫功能低下个体接种黄热病疫苗后发生不良事件的风险,并与非免疫功能低下个体接种疫苗后的情况进行比较。

方法

检索MEDLINE、LILACS、EMBASE、SCOPUS、DARE、Toxiline、Web of Science和灰色文献数据库,检索截至2021年2月的出版物。纳入随机和半随机临床试验以及观察性研究,研究对象包括免疫功能低下参与者(感染HIV者、器官移植者、癌症患者、因风湿性疾病使用免疫抑制药物者以及因其他疾病接受免疫抑制治疗者)。观察性或非随机研究的方法学质量采用ROBINS-I工具进行评估。进行了两项荟萃分析,即比例分析和危险因素分析,以确定具有适合合并变量的研究中相对风险(RR)的汇总指标。

结果

纳入25项研究,大多数研究的偏倚风险被归类为严重。13项研究有足够数据进行拟议的荟萃分析。7项无对照组的研究结果汇总于比例荟萃分析中,结果显示免疫功能低下个体接种疫苗后发生不良事件的风险为8.5%[95%置信区间(CI)0.07 - 21.8]。合并6项队列研究,RR为1.00(95%CI 0.78 - 1.29)。根据免疫抑制病因进行亚组分析,也未能发现接种疫苗后不良事件风险增加。

结论

无法确定免疫功能低下个体,无论病因如何,接种黄热病疫苗后发生不良事件的风险更高。

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