怀孕期间呼吸道同胞免疫接种的孕产妇安全结果与大规模数据库
Taito Kitano1,2,3, Toshiyuki Sado4, Shinya Tsuzuki5,6,7
1Department of Pediatrics, Nara Prefecture General Medical Center, Nara, Japan. tkitano@nara-hp.jp.
NPJ vaccines
|January 15, 2026
概括
使用RSVpreF进行母体RSV接种并没有增加早产或其他不良妊娠结果的风险. 建议对罕见事件进行进一步的安全监测.
科学领域:
- 产科和妇科 产科和妇科
- 疫苗学 疫苗学 疫苗学
- 孕产妇和胎儿医学 孕产妇和胎儿医学
背景情况:
- 呼吸道同胞病毒 (RSV) 对婴儿构成重大威胁,母体疫苗接种是提供被动免疫力的策略.
- 现实世界的数据对于评估RSVpreF.等新型孕产妇疫苗的安全性至关重要.
研究的目的:
- 评估在怀孕期间接种预注射F蛋白 (RSVpreF) 疫苗后产妇安全结果的风险.
- 使用倾向性得分匹配,比较接种疫苗和未接种疫苗的孕妇之间的结果.
主要方法:
- 使用大规模现实世界数据进行回顾性队列研究.
- 倾向性匹配得分比较11265名接种疫苗的妇女和11265名未接种疫苗的妇女.
- 评估早产,妊娠高血压障碍,妊娠期糖尿病,卵巢水,胎盘断裂,子宫内生长限制和子宫内胎儿死亡的风险.
主要成果:
- 没有观察到过早分娩 (OR 0.98),妊娠高血压障碍 (OR 1.01),妊娠糖尿病 (OR 0.98),胎盘断裂 (OR 0.99),子宫内生长限制 (OR 0.94),或子宫内胎儿死亡 (OR 0.68) 的风险有统计学意义的增加.
- 在接种疫苗的群体中,观察到橄水症风险的统计显著下降 (OR 0.77,p=0.015).
- 母亲RSV疫苗接种并没有提高选择的母体不良结果的风险.
结论:
- 在怀孕期间接种预注射F蛋白 (RSVpreF) 疫苗似乎是安全的关于选择的母体结果.
- 虽然没有发现增加的风险,但需要使用更大的样本进行持续的安全监测,以确定罕见的不良事件或微小的风险差异.
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