Service de Pharmacologie Médicale, CHU Toulouse, Université de Toulouse, INSERM 1027, Toulouse, France.
BJOG. 2014 Jun;121(7):895-900. doi: 10.1111/1471-0528.12617. Epub 2014 Feb 11.
To compare pregnancy outcome between women exposed and unexposed to oseltamivir during pregnancy.
A comparative observational cohort study of women exposed to oseltamivir during pregnancy.
A French prescription database (EFEMERIS) that includes data for pregnant women was used. EFEMERIS records prescribed and dispensed reimbursed drugs during pregnancy and pregnancy outcomes in Haute-Garonne, South West France.
Women who delivered from 1 July 2004 to 31 December 2010.
The study compared exposed and unexposed pregnant women. Two women unexposed to oseltamivir were individually matched, by maternal age, month, and year of delivery, with one women exposed to oseltamivir. Multivariable conditional logistic regression and multivariable Cox proportional hazards regression were used to evaluate associations between each outcome and exposure to oseltamivir during pregnancy.
Pregnancy loss for any cause, preterm delivery, low birthweight, neonatal pathology, and congenital malformation.
A cohort of 337 (0.58% of women included in EFEMERIS) women exposed to oseltamivir were compared with 674 unexposed women. The risk for pregnancy loss (HR 1.52; 95% CI 0.80-2.91), for preterm birth (adjusted OR 0.64; 95% CI 0.31-1.27), and for neonatal pathology (adjusted OR 0.62; 95% CI 0.23-1.54) did not differ between exposed and unexposed groups. When exposure during organogenesis was considered, one case of congenital anomaly (2.0%) among 49 exposed women and one case (1.0%) among 99 unexposed women were observed (crude OR 2.00; 95% CI 0.13-32.00).
There was no significant association between adverse pregnancy outcomes and exposure to oseltamivir during pregnancy.
比较孕期暴露于奥司他韦与未暴露于奥司他韦的女性的妊娠结局。
一项孕期暴露于奥司他韦的女性的对比观察性队列研究。
使用了一个包含法国处方数据库（EFEMERIS）的数据，该数据库包括法国南部上加龙省孕妇的孕期用药和妊娠结局数据。
2004 年 7 月 1 日至 2010 年 12 月 31 日分娩的女性。
本研究比较了暴露于奥司他韦与未暴露于奥司他韦的孕妇。将每一位暴露于奥司他韦的孕妇与两名按母亲年龄、月份和分娩年份匹配的未暴露于奥司他韦的孕妇进行匹配。采用多变量条件逻辑回归和多变量 Cox 比例风险回归来评估每个结局与孕期暴露于奥司他韦之间的关联。
任何原因的妊娠丢失、早产、低出生体重、新生儿疾病和先天性畸形。
337 名（EFEMERIS 中纳入女性的 0.58%）暴露于奥司他韦的孕妇与 674 名未暴露于奥司他韦的孕妇进行了比较。两组间妊娠丢失的风险（HR 1.52；95%CI 0.80-2.91）、早产的风险（调整后的 OR 0.64；95%CI 0.31-1.27）和新生儿疾病的风险（调整后的 OR 0.62；95%CI 0.23-1.54）均无显著差异。当考虑器官发生期暴露时，49 名暴露于奥司他韦的孕妇中有 1 例（2.0%）出现先天性异常，99 名未暴露于奥司他韦的孕妇中有 1 例（1.0%）出现先天性异常（粗 OR 2.00；95%CI 0.13-32.00）。
孕期暴露于奥司他韦与不良妊娠结局之间无显著关联。
