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Pandemic A/H1N1 influenza vaccination during pregnancy: A comparative study using the EFEMERIS database

机译：妊娠期大流行性甲型H1N1流感疫苗接种：使用EFEMIRIS数据库的比较研究

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Objective: To evaluate the risk of adverse pregnancy outcomes following A/H1N1 vaccination in pregnant women. Methods: This observational cohort study compared vaccinated and non-vaccinated pregnant women in EFEMERIS, a French prescription database including pregnant women. Women who ended their pregnancy in South Western France between October 21, 2009 and November 30, 2010 (the period of the French vaccination campaign) were included. Two non-vaccinated women were individually matched to each vaccinated woman by month and year of pregnancy onset. Conditional logistic regression and Cox proportional hazards regression were used to evaluate associations between each outcome (all-cause pregnancy loss, preterm delivery, small for gestational age (SGA) and neonatal pathology) and A/H1N1 vaccination during pregnancy. Results: 1645 women of the 12,120 (13.6) in the database who were administered A/H1N1 vaccine during pregnancy were compared to 3290 non-vaccinated women. Most were vaccinated in December 2009 (61) with a non-adjuvanted vaccine (93). The risks of pregnancy loss (adjusted HR= 0.56; 95 CI= 0.31-1.01), of preterm birth (adjusted HR = 0.82; 95 CI = 0.64-1.06), and of neonatal pathology (adjusted OR = 0.70; 95 CI = 0.49-1.02) did not differ between the vaccinated and the non-vaccinated groups. The rate of SGA was lower in the vaccinated group than in the non-vaccinated group (0.5 vs. 1.4; adjusted OR = 0.36; 95 CI = 0.17-0.78). Conclusion: There was no significant association between adverse pregnancy outcomes and vaccination with a non-adjuvanted A/H1N1 vaccine during pregnancy
机译：目的：评估孕妇接种甲型H1N1疫苗后不良妊娠结局的风险。方法：这项观察性队列研究比较了包括孕妇在内的法国处方数据库 EFEMERIS 中接种疫苗和未接种疫苗的孕妇。包括2009年10月21日至2010年11月30日（法国疫苗接种运动期间）在法国西南部终止妊娠的妇女。两名未接种疫苗的妇女按怀孕月份和年份分别与每位接种疫苗的妇女进行匹配。采用条件logistic回归和Cox比例风险回归评估各结局（全因流产、早产、小于胎龄儿（SGA）和新生儿病理学）与妊娠期A/H1N1疫苗接种之间的关联。结果：在数据库中，12,120名妇女中有1645名（13.6%）在怀孕期间接种了甲型H1N1疫苗，与3290名未接种疫苗的妇女进行了比较。大多数人在2009年12月（61%）接种了非佐剂疫苗（93%）。妊娠丢失（校正HR=0.56;95%CI=0.31-1.01）、早产（校正HR=0.82;95%CI=0.64-1.06）和新生儿病理（校正OR=0.70;95%CI=0.49-1.02）的风险在接种疫苗组和未接种疫苗组之间没有差异。接种疫苗组的SGA发生率低于未接种疫苗组（0.5% vs. 1.4%;校正OR=0.36;95%CI=0.17-0.78）。结论：不良妊娠结局与妊娠期接种非佐剂甲型H1N1疫苗无显著相关性

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