孕妇接种甲型H1N1流行性感冒疫苗后的安全性分析

Safety analysis on the influenza A/H1N1 vaccine in pregnant women

目的评价孕妇接种甲型H1N1流行性感冒裂解疫苗(简称甲流疫苗)后的安全性。方法从自愿接种甲流疫苗的孕妇中按照孕早期和孕中后期分层,每一层随机抽取60名孕妇,同时设置对照组,观察孕妇接种甲流疫苗后出现的不良反应情况(Adverse Events Following Immunization,AEFI)以及比较接种组和对照组妊娠并发症、妊娠结局情况。结果孕妇接种甲流疫苗的不良反应发生率为6.67%,孕中后期和孕早期AEFI发生率差异无统计学意义(χ2校正=1.21,P>0.05);发生的AEFI全部为一般反应;接种组和对照组发生妊娠并发症的差异无统计学意义(Fisher确切概率P=0.16),发生不良结局的差异也无统计学意义(χ2=0.48,P>0.05)。结论甲流疫苗对孕妇接种是安全的,且于怀孕各期均可接种,为保护母亲及其婴儿免受甲流病毒侵袭,母亲在怀孕期间接种甲流疫苗是一种很好的选择。

Objective To analyze the safety of Influenza A/H1N1 split virus influenza vaccine in pregnant woman. Method The pregnant women who voluntarily vaccinated with influenza A/H1N1 Vaccine was strati-fied according to the first trimester （3 months） and late in pregnancy （ after 3 months of pregnancy to pre - production） . 60 pregnant women were random selected from each layer and the control group was set at the same time. The adverse events following immunization （AEFI） of vaccination group and the comparison of pregnancy complications and pregnancy outcomes between the vaccination group and the control group were ob-served. Results The incidence rate of AEFI cases of influenza A/H1N1 vaccination in pregnant woman was 6. 67%, The difference of incidence rate of AEFI between the first trimester and late in pregnancy had no sta- tistically significance （X2correction = 1.21, P 〉0. 05）, in which were all general reactions. Either the differ-ence of pregnancy complications （Fisher exact P = 0. 16） or the difference of adverse pregnancy outcomes （X^2 = 0. 48, P 〉 0. 05 ） in vaccination group and control group had no statistically significance. Conclusions The influenza A/H1 N1 vaccine in this study was safe to pregnant woman of all stage. To protect the mothers and their babies from influenza A/H1 N1 virus, the vaccine inoculation of the mother during pregnancy was a good choice.