EV-A71疫苗对儿童有效性和安全性的meta分析

职业与健康 ›› 2024, Vol. 40 ›› Issue (24): 3432-3436.

EV-A71疫苗对儿童有效性和安全性的meta分析

赵晓丽^a, 高璟英^a, 强月华^a, 邢彦博^b, 尚明宇^a

山西医科大学 a儿科医学系,b第二临床医学院,山西太原 030001

收稿日期:2024-04-07 修回日期:2024-04-15 出版日期:2024-12-15 发布日期:2026-04-09
通信作者: 高璟英,副教授,E-mail：13633513158@163.com
作者简介:赵晓丽,女,在读硕士研究生,研究方向为小儿营养。
基金资助:
中华医学会医学教育分会和中国高等教育学会医学教育专业委员会医学教育研究立项重点课题（2020A-N02041）; 山西省高等学校教学改革创新项目（J20220412）

Effectiveness and safety of EV-A71 vaccine in children：A meta-analysis

ZHAO Xiaoli^a, GAO Jingying^a, QIANG Yuehua^a, XING Yanbo^b, SHANG Mingyu^a

a Department of Pediatrics, b Second School of Clinical Medicine,Shanxi Medical University,Taiyuan,Shanxi 030001,China

Received:2024-04-07 Revised:2024-04-15 Online:2024-12-15 Published:2026-04-09
Contact: GAO Jingying,Associate professor,E-mail：13633513158@163.com

摘要/Abstract

摘要： 目的通过系统回顾和荟萃分析,评估肠道病毒A71型（enterovirus A71,EV-A71）疫苗在儿童中的有效性和安全性。方法在PubMed、Cochrane Library、Embase、Web of Science对相关的随机对照试验（randomized controlled trials,RCTs）进行全面搜索,收集自建立数据库以来至2023年9月国内外公开发表的文献。所有数据均采用RevMan 5.3统计软件进行汇总,以风险比（relative risk,RR）及其95%置信区间作为效应量。结果纳入6项RCTs,meta分析结果表明,疫苗组对EV-A71相关疾病预防率高于安慰剂组（RR=0.08,95%CI：0.03~0.21,P<0.01）,保护效果为92%（95%CI：79%~97%）;疫苗组对EV-A71相关疾病住院预防率高于安慰剂组（RR=0.04,95%CI：0.01~0.20,P<0.01）,保护效果为96%（95%CI：80%~99%）;疫苗组对出现严重并发症的预防率高于安慰剂组（RR=0.12,95%CI：0.02~0.65,P<0.05）,保护效果为88%（95%CI：35%~98%）。疫苗安全性分析中,除易怒嗜睡虚弱及三级腹泻的发生率疫苗组高于安慰剂组外,其余不良反应无明显差异,且多为一过性,预后良好。结论 EV-A71疫苗对因EV-A71感染引起的手足口病（hand,foot and mouth disease,HFMD）预防是有效的,对住院及严重并发症发生预防也有效,同时具有较高的安全性。

关键词: 人肠道病毒, 疫苗, 手足口病, Meta分析

Abstract: Objective To assess the efficacy and safety of enterovirus A71（EV-A71） vaccine in children through systematic review and meta-analysis. Methods A comprehensive search for relevant randomized controlled trials（RCTs） was conducted in PubMed,Cochrane Library,Embase,and Web of Science databases. The literature published at home and abroad since the establishment of the database until September 2023 was collected. All data were summarized using RevMan 5.3 statistical software,and risk ratios （RR） and their 95% confidence intervals were used as effect sizes. Results Six RCTs were included. The results of meta-analysis showed that the vaccine group had a higher prevention rate of EV-A71-related diseases than the placebo group（RR=0.08,95%CI：0.03-0.21,P<0.01）,with a protection effect of 92%（95%CI：79%-97%）. The vaccine group had a higher prevention rate of hospitalization for EV-A71-related diseases than the placebo group（RR=0.04,95%CI：0.01-0.20,P<0.01）,with a protection effect of 96%（95%CI：80%-99%）. The vaccine group had a higher prevention rate of developing serious complications than the placebo group（RR=0.12,95%CI：0.02-0.65,P<0.05）,with a protection effect of 88%（95%CI：35%-98%）. In the vaccine safety analysis,except for the incidence rates of irritability,drowsiness,weakness and tertiary diarrhea were higher in the vaccine group than in the placebo group,there was no significant difference in other adverse reactions,and most of them were transient and had a good prognosis. Conclusion The EV-A71 vaccine is effective in the prevention of hand,foot and mouth disease（HFMD） due to EV-A71 infection,as well as in the prevention of hospitalization and the occurrence of serious complications,while having a high safety profile.

Key words: Human enterovirus, Vaccine, Hand, foot and mouth disease, Meta-analysis

中图分类号:

R181.2

赵晓丽, 高璟英, 强月华, 邢彦博, 尚明宇. EV-A71疫苗对儿童有效性和安全性的meta分析. [J]职业与健康, 2024, 40(24): 3432-3436.

ZHAO Xiaoli, GAO Jingying, QIANG Yuehua, XING Yanbo, SHANG Mingyu. Effectiveness and safety of EV-A71 vaccine in children：A meta-analysis. [J]OCCUPATION AND HEALTH, 2024, 40(24): 3432-3436.

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