Maternal Safety of Trivalent Inactivated Influenza Vaccine in Pregnant Women
Maternal Safety of Trivalent Inactivated Influenza Vaccine in Pregnant Women
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DOI：
10.1097/aog.0b013e3182831b83
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发表时间：
2013-03-01
影响因子：
7.2
通讯作者：
Olsen, Avalow
中科院分区：
文献类型：
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作者：
Nordin, James D.;Kharbanda, Elyse Olshen;Olsen, Avalow
目的：为了估计在接受三价灭活流感疫苗后42天内发生的医疗事件的风险，并评估孕早期接种疫苗的特定风险：这项回顾性观察性队列研究比较了疫苗安全性数据链中三价灭活流感疫苗接种和未接种的孕妇的医疗不良事件发生率。使用泊松分布和对数链接，我们计算了产妇调整后的发病率比的复合安全性结果为整个队列和接种疫苗的子集在头三个月。结果：队列包括75,906接种疫苗（28.4%，在头三个月）和147,992未接种疫苗的妇女匹配的年龄，地点，怀孕开始日期。在接种后的前3天内，三价灭活流感疫苗与特定医疗事件（包括过敏反应、蜂窝织炎和癫痫发作）的风险增加无关（全队列调整的发病率比为1.12，95%置信区间[CI]为0.81-1.55; P= 0.48;孕早期校正的发病率比为0.97，95%CI为0.53-1.78; P= 0.93）。在最初的42天内，没有发现格林-巴利综合征、视神经炎、横肌麻痹或贝尔麻痹的事件病例。三价灭活流感疫苗与血小板减少症无关（全队列校正的发病率比0.90，95% CI 0.68-1.19; P= 0.45;妊娠早期校正的发病率比0.56，95% CI 0.22-1.39; P=.21）或急性神经系统事件（全队列校正的发病率比0.92，95% CI 0.54-1.6; P= 0.75;妊娠早期校正的发病率比1.05，95% CI 0.46-2.38;结论：妊娠期间接种三价灭活流感疫苗与接种后42天内不良事件风险增加无关，支持其对母亲的安全性。（Obstet Gynecol 2013;121：519-25）DOI：http：//10.1097/AOG.0b013e3182831b83
OBJECTIVE: To estimate the risks for medically attended events occurring within 42 days of receiving trivalent inactivated influenza vaccine and to evaluate specific risks of first-trimester vaccination.METHODS: This retrospective observational cohort study compared rates of medically attended adverse events in trivalent inactivated influenza-vaccinated and unvaccinated pregnant women in the Vaccine Safety Datalink. Using a Poisson distribution and log link, we calculated maternal adjusted incident rate ratios for composite safety outcomes for the full cohort and the subset vaccinated during the first trimester.RESULTS: The cohort included 75,906 vaccinated (28.4% in the first trimester) and 147,992 unvaccinated women matched by age, site, and pregnancy start date. In the first 3 days after vaccination, trivalent inactivated influenza vaccine was not associated with increased risk of specified medically attended events, including allergic reactions, cellulitis, and seizures (full cohort adjusted incident rate ratio 1.12, 95% confidence interval [CI] 0.81-1.55; P=.48; first-trimester adjusted incident rate ratio .97, 95% CI 0.53-1.78; P=.93). In the first 42 days, no incident cases of Guillain-Barre syndrome, optic neuritis, transverse myelitis, or Bells palsy were identified. Trivalent inactivated influenza vaccine was not associated with thrombocytopenia (full cohort adjusted incident rate ratio 0.90, 95% CI 0.68-1.19; P=.45; first-trimester adjusted incident rate ratio 0.56, 95% CI 0.22-1.39; P=.21) or an acute neurologic event (full cohort adjusted incident rate ratio 0.92, 95% CI 0.54-1.6; P=.75; first-trimester adjusted incident rate ratio 1.05, 95% CI 0.46-2.38; P=.91).CONCLUSIONS: Receipt of trivalent inactivated influenza vaccine during pregnancy was not associated with increased risk of adverse events in the 42 days after vaccination, supporting its safety for the mother. (Obstet Gynecol 2013;121:519-25) DOI: http://10.1097/AOG.0b013e3182831b83