妊娠期接种新冠疫苗与常见妊娠并发症和不良出生结局发生风险的meta分析
Association between COVID-19 vaccination during pregnancy and the risk of common pregnancy complications and adverse birth outcomes: a meta-analysis
摘要目的:分析妊娠期接种新冠疫苗与孕妇妊娠并发症和新生儿不良出生结局发生风险的关系,为改进孕妇接种新冠疫苗策略提供依据。方法:以“covid-19 vaccines”“covid19”“covid 19”“vaccin*”“neonatal outcomes”“perinatal outcomes”“pregnancy outcomes”“premature birth”“新型冠状病毒疫苗”“妊娠并发症”“出生结局”“围产期结局”为主要检索词,采用主题词+自由词的方法,在PubMed、Web of Science、Scopus、Cochrane library、中国知网、万方数据库、维普中文期刊服务平台、中国生物医学文献数据数据库中进行检索。检索时间为2020年1月1日至2022年5月27日。使用Stata16.0进行meta分析,计算合并后的效应值,进行异质性检验、敏感性分析和发表偏倚评估。结果:共检索到482篇相关文献,根据纳入和排除标准,共纳入12篇英文文献,有88 682名孕妇在妊娠期接种疫苗。meta分析结果显示孕妇在妊娠期接种新冠疫苗不会增加妊娠高血压、产后出血、新生儿早产、小于胎龄儿和新生儿5 min Apgar评分<7的发生风险,合并后的相对危险度(relative risk, RR)及95%置信区间(95% confidence interval,95% CI)分别为0.97(0.91~1.05)、1.01(0.83~1.23)、0.92(0.77~1.10)、0.97(0.90~1.04)和0.93(0.87~1.00)。孕妇是否接种新冠疫苗两组间的新生儿出生体质量差异无统计学意义,合并后的均数差(mean difference,MD)及95% CI为-18.26(-40.39~3.87) g。但结果显示孕妇在妊娠期接种新冠疫苗可能会增加妊娠糖尿病的发生风险,合并后的 RR(95% CI)为1.14(1.03~1.26)。此外,敏感性分析表明结果可靠性较好, Egger’s检验和Begg’s检验结果均表明纳入文献之间不存在发表偏倚。 结论:基于国外7个国家的研究提供的证据不支持孕妇在妊娠期接种新冠疫苗会增加常见妊娠并发症和新生儿不良出生结局的发生风险,但仍需更多国内的研究为孕妇接种新冠疫苗提供安全性证据。
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abstractsObjective:To evaluate the associations of COVID-19 vaccination during pregnancy with the risk of pregnancy complications and neonatal adverse birth outcomes, and to provide evidence for improving strategies for COVID-19 vaccination during pregnancy.Methods:"covid-19 vaccines" "covid19" "covid 19" "vaccin*" "neonatal outcomes" "perinatal outcomes" "pregnancy outcomes" "premature birth" were used as the main search terms. Articles published from January 1st 2020 to May 27th 2022 were searched in PubMed, Web of Science, Scopus, Cochrane library, CNKI, Wanfang Database, VIP Database and Chinese Biomedical Literature Database by adopting the method of the combination of MeSH words and free words. Stata16.0 software was used to calculate pooled effect values, perform heterogeneity test and sensitivity analysis and assess publication bias.Results:According to the inclusion and exclusion criteria, a total of 12 English papers were included from 482 relevant literatures retrieved, with 88 682 pregnant women vaccinated during pregnancy. Meta-analysis results showed that COVID-19 vaccination in pregnancy did not increase the risk of gestational hypertension, postpartum hemorrhage, neonatal preterm birth, small-for-gestational-age infants, and 5 min Apgar score<7, with pooled relative risk ( RR) and 95% confidence interval (95% CI) of 0.97 (0.91-1.05), 1.01 (0.83-1.23), 0.92 (0.77-1.10), 0.97 (0.90-1.04) and 0.93 (0.87-1.00), respectively. There was no significant difference in neonatal birth weight between the two groups of pregnant women who received COVID-19 vaccine or not, and the combined mean difference (MD) and 95% CI was -18.26 (-40.39-3.87) g. However, COVID-19 vaccination in pregnancy may increase the risk of gestational diabetes and the combined RR (95% CI) was 1.14 (1.03-1.26). In addition, sensitivity analysis showed that the results were stable and reliable. Egger's test and Begg's test showed that there was no publication bias among the included studies. Conclusion:This study does not support the increased risk of pregnancy complications and neonatal adverse birth outcomes for pregnant women vaccinated against COVID-19, but more researches are still needed to provide evidence of the safety of COVID-19 vaccination in pregnancy.
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