COVID-19 疫苗对母婴围产结局的有效性和安全性：系统评价和荟萃分析。
Effectiveness and safety of COVID-19 vaccines on maternal and perinatal outcomes: a systematic review and meta-analysis.
机构信息
WHO Collaborating Centre for Global Women's Health, Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK.
Clinical Biostatistics Unit, Hospital Universitario Ramón y Cajal, Madrid, Spain.
出版信息
BMJ Glob Health. 2024 Apr 4;9(4):e014247. doi: 10.1136/bmjgh-2023-014247.
OBJECTIVE
To assess the effects of COVID-19 vaccines in women before or during pregnancy on SARS-CoV-2 infection-related, pregnancy, offspring and reactogenicity outcomes.
DESIGN
Systematic review and meta-analysis.
DATA SOURCES
Major databases between December 2019 and January 2023.
STUDY SELECTION
Nine pairs of reviewers contributed to study selection. We included test-negative designs, comparative cohorts and randomised trials on effects of COVID-19 vaccines on infection-related and pregnancy outcomes. Non-comparative cohort studies reporting reactogenicity outcomes were also included.
QUALITY ASSESSMENT, DATA EXTRACTION AND ANALYSIS: Two reviewers independently assessed study quality and extracted data. We undertook random-effects meta-analysis and reported findings as HRs, risk ratios (RRs), ORs or rates with 95% CIs.
RESULTS
Sixty-seven studies (1 813 947 women) were included. Overall, in test-negative design studies, pregnant women fully vaccinated with any COVID-19 vaccine had 61% reduced odds of SARS-CoV-2 infection during pregnancy (OR 0.39, 95% CI 0.21 to 0.75; 4 studies, 23 927 women; I=87.2%) and 94% reduced odds of hospital admission (OR 0.06, 95% CI 0.01 to 0.71; 2 studies, 868 women; I=92%). In adjusted cohort studies, the risk of hypertensive disorders in pregnancy was reduced by 12% (RR 0.88, 95% CI 0.82 to 0.92; 2 studies; 115 085 women), while caesarean section was reduced by 9% (OR 0.91, 95% CI 0.85 to 0.98; 6 studies; 30 192 women). We observed an 8% reduction in the risk of neonatal intensive care unit admission (RR 0.92, 95% CI 0.87 to 0.97; 2 studies; 54 569 women) in babies born to vaccinated versus not vaccinated women. In general, vaccination during pregnancy was not associated with increased risk of adverse pregnancy or perinatal outcomes. Pain at the injection site was the most common side effect reported (77%, 95% CI 52% to 94%; 11 studies; 27 195 women).
CONCLUSION
COVID-19 vaccines are effective in preventing SARS-CoV-2 infection and related complications in pregnant women.
PROSPERO REGISTRATION NUMBER
CRD42020178076.
目的
评估 COVID-19 疫苗在妊娠前或妊娠期间对 SARS-CoV-2 感染相关、妊娠、后代和不良反应结局的影响。
设计
系统评价和荟萃分析。
数据来源
2019 年 12 月至 2023 年 1 月间的主要数据库。
研究选择
9 对评审员参与了研究选择。我们纳入了测试阴性设计、对照队列和 COVID-19 疫苗对感染相关和妊娠结局影响的随机试验。也纳入了报告不良反应结局的非对照队列研究。
质量评估、数据提取和分析：两名评审员独立评估了研究质量并提取了数据。我们进行了随机效应荟萃分析，并以 HR、风险比（RR）、比值比（OR）或 95%CI 内的率报告结果。
结果
纳入了 67 项研究（1813947 名女性）。总体而言，在测试阴性设计研究中，完全接种任何 COVID-19 疫苗的孕妇在妊娠期间感染 SARS-CoV-2 的几率降低了 61%（OR 0.39，95%CI 0.21 至 0.75；4 项研究，23927 名女性；I²=87.2%），住院的几率降低了 94%（OR 0.06，95%CI 0.01 至 0.71；2 项研究，868 名女性；I²=92.0%）。在调整后的队列研究中，妊娠高血压疾病的风险降低了 12%（RR 0.88，95%CI 0.82 至 0.92；2 项研究；115085 名女性），而剖宫产的风险降低了 9%（OR 0.91，95%CI 0.85 至 0.98；6 项研究；30192 名女性）。我们观察到，与未接种疫苗的女性相比，接种疫苗的女性所生婴儿入住新生儿重症监护病房的风险降低了 8%（RR 0.92，95%CI 0.87 至 0.97；2 项研究；54569 名女性）。一般来说，妊娠期间接种疫苗与不良妊娠或围产期结局风险增加无关。注射部位疼痛是报告最多的常见副作用（77%，95%CI 52% 至 94%；11 项研究；27195 名女性）。
结论
COVID-19 疫苗可有效预防孕妇 SARS-CoV-2 感染及其相关并发症。
PROSPERO 注册号：CRD42020178076。
Zotero 插件