Lipkind Heather S, Vazquez-Benitez Gabriela, Nordin James D, Romitti Paul A, Naleway Allison L, Klein Nicola P, Hechter Rulin C, Jackson Michael L, Hambidge Simon J, Lee Grace M, Sukumaran Lakshmi, Kharbanda Elyse O
Department of Obstetrics, Gynecology, & Reproductive Sciences, Yale University School of Medicine, New Haven, Connecticut; HealthPartners Institute, Minneapolis, Minnesota; the Department of Epidemiology, University of Iowa, Iowa City, Iowa; the Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon; the Vaccine Study Center, Kaiser Permanente Northern California, Oakland, California; the Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, California; Group Health Research Institute, Seattle, Washington; the Institute for Health Research, Kaiser Permanente Colorado and Ambulatory Care Services, Denver Health, Denver, Colorado; Harvard Pilgrim Health Care Institute & Harvard Medical School, Boston, Massachusetts; and the Centers for Disease Control and Prevention, Atlanta, Georgia.
Obstet Gynecol. 2017 Sep;130(3):599-608. doi: 10.1097/AOG.0000000000002191.
To evaluate whether quadrivalent human papillomavirus vaccine (4vHPV) administered during the periconceptional period or during pregnancy was associated with increased risks for adverse obstetric events, adverse birth outcomes, or selected major structural birth defects.
We conducted a retrospective, observational cohort study using administrative and health care data from the Vaccine Safety Datalink. Insured women 13-27 years old with singleton pregnancies and a live birth from January 1, 2007, through September 1, 2013, who received 4vHPV during the periconceptional period (2 weeks before to 2 weeks after their last menstrual period), during pregnancy, or during both periods combined were compared with women who had a live birth during the same time period and received 4vHPV 4-18 months before their last menstrual period. We examined risks of gestational diabetes, hypertensive disorders of pregnancy, chorioamnionitis, preterm birth, small-for-gestational-age birth, and selected major structural birth defects in offspring. We estimated relative risks associated with receipt of 4vHPV during the periconceptional period, during pregnancy, and both exposure periods combined using a generalized linear model with Poisson distribution including a propensity score that included relevant maternal demographic and pregnancy characteristics.
Of 92,579 potentially eligible pregnant women, 720 received 4vHPV during the periconceptional period, 638 received 4vHPV during pregnancy, and 8,196 received 4vHPV during the comparison period. Administration of 4vHPV during pregnancy was not associated with increased risk of adverse obstetric events, birth outcomes. Preterm birth occurred in 7.9% of pregnancies with vaccine exposures during pregnancy compared with 7.6% of pregnancies with vaccination in the comparison period (adjusted relative risk 0.97, 95% CI 0.72-1.3). Major structural birth defects were diagnosed in 2.0% of pregnancies with vaccine exposure during pregnancy compared with 1.8% of pregnancies with vaccine exposure during the comparison period (adjusted prevalence ratio 1.0, 95% CI 0.52-1.9). Results were similar for 4vHPV exposure during the periconceptional period.
Quadrivalent HPV vaccine inadvertently administered in pregnancy or during the periconceptional period was not associated with adverse pregnancy or birth outcomes.
评估在受孕期间或孕期接种四价人乳头瘤病毒疫苗（4vHPV）是否会增加不良产科事件、不良出生结局或特定主要结构出生缺陷的风险。
我们利用疫苗安全数据链中的管理和医疗数据进行了一项回顾性观察队列研究。将2007年1月1日至2013年9月1日期间年龄在13 - 27岁、单胎妊娠且活产的参保妇女纳入研究，这些妇女在受孕期间（末次月经前2周至上一次月经后2周）、孕期或两个时期均接种了4vHPV，将其与同期活产且在末次月经前4 - 18个月接种4vHPV的妇女进行比较。我们研究了妊娠糖尿病、妊娠高血压疾病、绒毛膜羊膜炎、早产、小于胎龄儿出生以及子代特定主要结构出生缺陷的风险。我们使用广义线性模型和泊松分布估计与受孕期间、孕期以及两个暴露期接种4vHPV相关的相对风险，该模型包括一个倾向得分，其中纳入了相关的母亲人口统计学和妊娠特征。
在92579名潜在符合条件的孕妇中，720名在受孕期间接种了4vHPV，638名在孕期接种了4vHPV，8196名在对照期接种了4vHPV。孕期接种4vHPV与不良产科事件、出生结局风险增加无关。孕期接种疫苗的妊娠中早产发生率为7.9%，而对照期接种疫苗的妊娠中早产发生率为7.6%（校正相对风险0.97，95%可信区间0.72 - 1.3）。孕期接种疫苗的妊娠中主要结构出生缺陷的诊断率为2.0%，而对照期接种疫苗的妊娠中该诊断率为1.8%（校正患病率比1.0，95%可信区间0.52 - 在受孕期间接种4vHPV的结果相似。
孕期或受孕期间意外接种四价人乳头瘤病毒疫苗与不良妊娠或出生结局无关。 1.9）。
