Karolinska Institutet, Centre for Pharmacoepidemiology, Department of Medicine, Solna, Stockholm, Sweden.
Pharmacoepidemiol Drug Saf. 2011 Oct;20(10):1030-4. doi: 10.1002/pds.2194. Epub 2011 Jul 19.
To compare birth outcomes between women exposed and unexposed to the antiviral medications oseltamivir or zanamivir during pregnancy.
This was an observational cohort study including women who gave birth to singletons in Sweden 2005-2007 and their infants. We obtained information from the national health registers and evaluated risks of low Apgar score, small for gestational age (SGA), low birth weight, preterm delivery, congenital malformations, birth-related death (stillbirth and neonatal death combined), and neonatal morbidity by conditional logistic regression. The unexposed [n = 860] were matched to the exposed [n = 86] by birth year and fetal gender.
A total of 81 women filled a prescription with oseltamivir only, 2 with zanamivir, and 3 with both oseltamivir and zanamivir. Compared with the unexposed infants, the exposed ones had higher risks of late transient hypoglycemia (crude OR = 4.00, 95%CI: 1.26-12.76). There were no statistical increased risks of low Apgar score, congenital malformations, SGA, low birth weight, preterm birth, or birth-related death. Adjusting for maternal age, parity, smoking, and body mass index had minor effects on the results. None of the women exposed to oseltamivir or zanamivir had been admitted to hospital for influenza during their pregnancy.
Except for an increased risk of late transient hypoglycemia, we found no increased risks of adverse birth outcomes among infants exposed to neuraminidase inhibitors in fetal life compared with the unexposed.
比较妊娠期间暴露于奥司他韦或扎那米韦抗病毒药物与未暴露于该药物的女性所分娩新生儿的结局。
这是一项观察性队列研究,纳入了 2005-2007 年在瑞典分娩单胎的女性及其婴儿。我们从国家健康登记处获取信息,并通过条件逻辑回归评估低 Apgar 评分、小于胎龄儿(SGA)、低出生体重、早产、先天性畸形、与分娩相关的死亡(死胎和新生儿死亡合计)和新生儿发病率的风险。未暴露组(n=860)按出生年份和胎儿性别与暴露组(n=86)匹配。
共有 81 名女性仅开具了奥司他韦处方,2 名女性开具了扎那米韦处方,3 名女性同时开具了奥司他韦和扎那米韦处方。与未暴露组的婴儿相比,暴露组的婴儿有更高的迟发性短暂低血糖风险(粗 OR=4.00,95%CI:1.26-12.76)。未发现 Apgar 评分低、先天性畸形、SGA、低出生体重、早产或与分娩相关的死亡风险增加。调整母亲年龄、产次、吸烟和体重指数对结果影响较小。没有暴露于奥司他韦或扎那米韦的女性在妊娠期间因流感住院。
除了迟发性短暂低血糖的风险增加外,我们发现与未暴露组相比,在胎儿期暴露于神经氨酸酶抑制剂的婴儿的不良出生结局风险没有增加。