Service de Pharmacologie Médicale, CHU Toulouse, Université de Toulouse, Inserm 1027, Toulouse, France.
Service de Pharmacologie Médicale, CHU Toulouse, Université de Toulouse, Inserm 1027, Toulouse, France.
Vaccine. 2014 Mar 5;32(11):1254-8. doi: 10.1016/j.vaccine.2014.01.021. Epub 2014 Jan 28.
To evaluate the risk of adverse pregnancy outcomes following A/H1N1 vaccination in pregnant women.
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.
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).
There was no significant association between adverse pregnancy outcomes and vaccination with a non-adjuvanted A/H1N1 vaccine during pregnancy.
评估孕妇接种 A/H1N1 疫苗后不良妊娠结局的风险。
这项观察性队列研究比较了 EFEMERIS 数据库中接受和未接受疫苗接种的孕妇，该数据库包括孕妇。研究对象为 2009 年 10 月 21 日至 2010 年 11 月 30 日期间在法国西南部结束妊娠的孕妇。每位接种疫苗的孕妇与未接种疫苗的孕妇按妊娠起始月份和年份进行 1:2 个体匹配。采用条件逻辑回归和 Cox 比例风险回归评估每种结局（所有原因妊娠丢失、早产、小于胎龄儿（SGA）和新生儿疾病）与孕期接种 A/H1N1 疫苗之间的关联。
在数据库中 12120 名接受 A/H1N1 疫苗接种的孕妇中，有 1645 名孕妇（占 13.6%）与 3290 名未接种疫苗的孕妇进行了比较。大多数孕妇于 2009 年 12 月（61%）接种了无佐剂疫苗（93%）。妊娠丢失的风险（调整后的 HR=0.56；95%CI=0.31-1.01）、早产的风险（调整后的 HR=0.82；95%CI=0.64-1.06）和新生儿疾病的风险（调整后的 OR=0.70；95%CI=0.49-1.02）在接种组和未接种组之间没有差异。接种组的 SGA 发生率低于未接种组（0.5% vs. 1.4%；调整后的 OR=0.36；95%CI=0.17-0.78）。
孕期接种无佐剂 A/H1N1 疫苗与不良妊娠结局之间无显著关联。
