Safety of pertussis vaccination in pregnant women in UK: observational study.
Safety of pertussis vaccination in pregnant women in UK: observational study.
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DOI：
10.1136/bmj.g4219
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发表时间：
2014-07-11
期刊：
影响因子：
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通讯作者：
Bryan P
中科院分区：
文献类型：
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作者：
Donegan K;King B;Bryan P
目的探讨妊娠期接种百日咳疫苗的安全性。设计观察性队列研究。设置英国临床实践研究数据链。研究对象为2074名中位年龄为30岁的孕妇，她们接种了百日咳疫苗，并与历史上未接种疫苗的对照组相匹配。主要结局指标：从妊娠期临床诊断中确定的不良事件，以及通过母婴联系从匹配的儿童记录中确定的额外数据。主要关注的事件是死产（妊娠24周后宫内死亡）。结果没有证据表明接种疫苗后14天内（发病率比0.69,95%可信区间0.23 ~ 1.62）或妊娠后期（0.85,0.44 ~ 1.61）死产的风险比全国历史发生率增加。与未接种疫苗的匹配历史队列孕妇相比，没有证据表明接种疫苗会加快分娩时间（风险比1.00,0.97至1.02）。此外，没有证据表明死产、产妇或新生儿死亡、先兆子痫或子痫、出血、胎儿窘迫、子宫破裂、胎盘或前置血管、剖腹产、低出生体重或新生儿肾功能衰竭的风险增加，这些都是妊娠期间自然发生的严重事件。结论：在妊娠晚期接种百日咳疫苗的妇女中，没有证据表明任何与妊娠相关的广泛预先确定的不良事件清单的风险增加。特别是，没有证据表明死产的风险增加。鉴于最近新生儿百日咳感染率、发病率和死亡率的上升，这些早期数据为卫生专业人员和公众评估疫苗在妊娠期的安全性提供了初步证据，并有助于为疫苗接种政策制定提供信息。
Objective To examine the safety of pertussis vaccination in pregnancy. Design Observational cohort study. Setting The UK Clinical Practice Research Datalink. Participants 20 074 pregnant women with a median age of 30 who received the pertussis vaccine and a matched historical unvaccinated control group. Main outcome measure Adverse events identified from clinical diagnoses during pregnancy, with additional data from the matched child record identified through mother-child linkage. The primary event of interest was stillbirth (intrauterine death after 24 weeks’ gestation). Results There was no evidence of an increased risk of stillbirth in the 14 days immediately after vaccination (incidence rate ratio 0.69, 95% confidence interval 0.23 to 1.62) or later in pregnancy (0.85, 0.44 to 1.61) compared with historical national rates. Compared with a matched historical cohort of unvaccinated pregnant women, there was no evidence that vaccination accelerated the time to delivery (hazard ratio 1.00, 0.97 to 1.02). Furthermore, there was no evidence of an increased risk of stillbirth, maternal or neonatal death, pre-eclampsia or eclampsia, haemorrhage, fetal distress, uterine rupture, placenta or vasa praevia, caesarean delivery, low birth weight, or neonatal renal failure, all serious events that can occur naturally in pregnancy. Conclusion In women given pertussis vaccination in the third trimester, there is no evidence of an increased risk of any of an extensive predefined list of adverse events related to pregnancy. In particular, there was no evidence of an increased risk of stillbirth. Given the recent increases in the rate of pertussis infection and morbidity and mortality in neonates, these early data provide initial evidence for evaluating the safety of the vaccine in pregnancy for health professionals and the public and can help to inform vaccination policy making.