妊娠期接种流感疫苗与不良妊娠结局的Meta分析

目的 系统评价妊娠期接种流感疫苗与不良妊娠结局的关系。方法 通过计算机检索结合手工检索PubMed、Embase、CNKI、VIP、WF等中英文数据库，查找关于妊娠期接种流感疫苗对妊娠结局影响且符合纳入排出标准的随机对照研究或队列研究，检索时限均从建库至2018年12月。由2位研究员筛选文献、提取资料并评价质量后，采用Stata 12.0软件进行Meta分析。结果 共纳入16个研究，共748 259例（试验组:145 980例；对照组:602 279例）。质量评价表明纳入文献质量较高。Meta分析结果显示，自然流产OR = 0.14,95%CI(0.10,0.18),P＜0.001]、死产OR = 0.71,95%CI(0.59,0.85),P＜0.001]、先天性畸形OR = 0.84,95%CI(0.54,1.30),P = 0.427＞0.05]均低于对照组，表明妊娠期接种流感疫苗不会增加自然流产、死产和先天性畸形的风险，并在一定程度上能降低不良妊娠发生率，敏感性分析表明结果可信，Begg’s法所得P值均表明不存在发表偏倚（自然流产:P = 0.466；死产:P = 1.00；先天性畸形P = 0.175）。结论 现有证据未表明母体流感疫苗接种与自然流产、死产和先天性畸形的风险增加有关，妊娠期接种流感疫苗在妊娠结局方面安全性较高，但仍可开展更多高质量研究予以验证。

Meta-analysis of influenza vaccination during pregnancy and adverse pregnancy outcomes

Objective To systematically evaluate the relationship between influenza vaccination during pregnancy and adverse pregnancy outcomes. Methods A randomized controlled trial or cohort study on the effects of influenza vaccination on pregnancy outcomes during pregnancy was searched by computer search combined with manual retrieval of PubMed, Embase, CNKI, VIP, and WF. The search time was from the establishment of the library to December 2018. Meta-analysis was performed using Stata 12.0 software after two researchers carefully selected the literature, extracted the data, and evaluated the quality according to the inclusion and exclusion criteria. Results This meta-analysis included 16 studies covering 748259 subjects, 145980 subjects in the experimental group and 602279 subjects in the control group. The quality evaluation results showed that most of the literature quality was high. The results showed that spontaneous abortionOR=0.14<1, 95%CI (0.10,0.18), P<0.001], stillbirthOR=0.71<1, 95%CI(0.59,0.85), P<0.001], congenital malformationOR=0.84<1, 95%CI (0.54,1.30), P=0.427>0.05] were lower than the control group. It indicated that influenza vaccination during pregnancy did not increase the risk of spontaneous abortion, stillbirth and congenital malformation, and could reduce the incidence of adverse pregnancy. Sensitivity analysis showed that the results were credible, and the P value obtained by Begg’s method showed no publication bias(natural abortion: P=0.466; stillbirth: P=1.00; congenital malformation: P=0.175). Conclusion The available evidence does not indicate that maternal influenza vaccination is associated with an increased risk of spontaneous abortion, stillbirth and congenital malformations. Influenza vaccination during pregnancy is safe in terms of pregnancy outcomes, but more high-quality studies are still needed to validate the safety.