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疫苗预防婴儿和老年人呼吸道合胞病毒感染的有效性和安全性:系统评价和荟萃分析。

Efficacy and safety of vaccines to prevent respiratory syncytial virus infection in infants and older adults: A systematic review and meta-analysis.

机构信息

Central Laboratory, Tianjin Fifth Central Hospital (Peking University Binhai Hospital), Tianjin, China; Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, China; Tianjin Key Laboratory of Epigenetic for Organ Development of Preterm Infants, Tianjin Fifth Central Hospital, Tianjin, China; Emergency Department of Tianjin Fifth Central Hospital, Tianjin, China.

Central Laboratory, Tianjin Fifth Central Hospital (Peking University Binhai Hospital), Tianjin, China; Tianjin Key Laboratory of Epigenetic for Organ Development of Preterm Infants, Tianjin Fifth Central Hospital, Tianjin, China; High Altitude Characteristic Medical Research Institute, Huangnan Tibetan Autonomous Prefecture People's Hospital, Qinghai, China.

出版信息

Int J Infect Dis. 2024 Sep;146:107118. doi: 10.1016/j.ijid.2024.107118. Epub 2024 Jun 13.

Abstract

OBJECTIVES

To determine the efficacy and safety of respiratory syncytial virus (RSV) vaccines in infants and older adults.

METHODS

We performed a systematic review and meta-analysis of randomized control trials that evaluated the efficacy of maternal RSV immunization against infections in infants, as well as the efficacy of RSV vaccines in older adults. The primary outcome was the vaccine efficacy against RSV-related lower respiratory tract disease (LRTD). Grading of Recommendations Assessment, Development and Evaluation criteria was used to evaluate the level of evidence.

RESULTS

Ten trials were included in the review. For maternal vaccination, the RSV vaccine showed favourable efficacy against RSV-related LRTD (vaccine efficacy 57.3%, 95% confidence interval [CI] 31.3-73.5; low certainty) and RSV-related severe LRTD (vaccine efficacy 81.9%, 95% CI 56.8-92.4; moderate certainty) in infants within 90 days after birth. For older adults, Meta-analysis showed that RSV vaccines could also reduce the risk of RSV-related LRTD (vaccine efficacy 78.3%, 95% CI 65.6-86.3; moderate certainty) and RSV-related severe LRTD (vaccine efficacy 86.5%, 95% CI 68.3-94.3; moderate certainty). There was no significant difference in serious adverse events between RSV vaccines and placebo.

CONCLUSION

RSV vaccines have the potential to offer protection against RSV disease in both infants and older adults, without apparent safety concerns.

摘要

目的

评估呼吸道合胞病毒(RSV)疫苗在婴儿和老年人中的疗效和安全性。

方法

我们对评估母亲 RSV 免疫接种对婴儿感染、以及 RSV 疫苗对老年人疗效的随机对照试验进行了系统评价和荟萃分析。主要结局为针对 RSV 相关下呼吸道疾病(LRTD)的疫苗效力。采用推荐评估、制定与评价分级标准来评估证据水平。

结果

共纳入 10 项研究。对于母亲接种疫苗,RSV 疫苗在婴儿出生后 90 天内对 RSV 相关 LRTD(疫苗效力 57.3%,95%置信区间 [CI] 31.3-73.5;低确定性)和 RSV 相关严重 LRTD(疫苗效力 81.9%,95% CI 56.8-92.4;中等确定性)具有良好的疗效。对于老年人,Meta 分析表明 RSV 疫苗也可降低 RSV 相关 LRTD(疫苗效力 78.3%,95% CI 65.6-86.3;中等确定性)和 RSV 相关严重 LRTD(疫苗效力 86.5%,95% CI 68.3-94.3;中等确定性)的风险。RSV 疫苗与安慰剂之间在严重不良事件方面没有显著差异。

结论

RSV 疫苗有可能为婴儿和老年人提供针对 RSV 疾病的保护,且无明显安全性问题。

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