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四价 TAK-003 登革热疫苗的有效性和安全性:系统评价。

Effectiveness and safety of the tetravalent TAK-003 dengue vaccine: a systematic review.

机构信息

Servicio de Clínica Médica, Hospital Alemán, Buenos Aires, Argentina. E-mail:

Servicio de Clínica Médica, Hospital Alemán, Buenos Aires, Argentina.

出版信息

Medicina (B Aires). 2024;84(4):689-707.

PMID:39172569
Abstract

In Argentina, the dengue virus has experienced an increase in recent years. This study aims to conduct a systematic review to evaluate the effectiveness and safety of the TAK-003 tetravalent dengue vaccine in this context. A systematic review of randomized controlled trials comparing the effectiveness and safety of the vaccine with placebo in the general population was conducted. The search was carried out in Epistemonikos, and two researchers independently assessed the studies. Risk of bias was evaluated using the Cochrane Rob 2 tool. A meta-analysis of the results was performed, and the certainty of evidence was assessed using the GRADE methodology. We concluded, with high certainty of evidence, that the tetravalent dengue vaccine reduces severe infections (RR 0.17, 95% CI 0.12 to 0.24) and infections by the dengue virus (RR 0.40, 95% CI 0.36 to 0.45) in a population ≤17 years. The vaccine may not increase the risk of serious adverse events, although it is important to note the low certainty of evidence (RR 1.04, 95% CI: 0.69-1.55). The use of the tetravalent dengue vaccine decreases the risk of severe and non-severe dengue infections in this population. However, there is low certainty of evidence regarding the vaccine's safety. The decision to vaccinate should consider the magnitude of benefits relative to the risk of infection.

摘要

在阿根廷,登革热病毒近年来有所增加。本研究旨在进行系统评价,以评估 TAK-003 四价登革热疫苗在这方面的有效性和安全性。系统评价了比较疫苗与安慰剂在普通人群中有效性和安全性的随机对照试验。在 Epistemonikos 进行了检索,两位研究人员独立评估了这些研究。使用 Cochrane Rob 2 工具评估偏倚风险。对结果进行了荟萃分析,并使用 GRADE 方法评估证据确定性。我们得出结论,具有高度证据确定性,四价登革热疫苗可降低≤17 岁人群的严重感染(RR 0.17,95%CI 0.12 至 0.24)和登革热病毒感染(RR 0.40,95%CI 0.36 至 0.45)。疫苗可能不会增加严重不良事件的风险,但值得注意的是证据确定性较低(RR 1.04,95%CI:0.69-1.55)。四价登革热疫苗可降低该人群中严重和非严重登革热感染的风险。然而,关于疫苗安全性的证据确定性较低。接种疫苗的决定应考虑与感染风险相关的获益程度。

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