Department of Pharmaceutical Services, Hiroshima University Hospital.
Department of Frontier Science for Pharmacotherapy, Graduate School of Biomedical and Health Sciences, Hiroshima University.
Biol Pharm Bull. 2024;47(7):1301-1306. doi: 10.1248/bpb.b24-00080.
Cefcapene pivoxil hydrochloride is an antibiotic often used by women who are or may be pregnant. However, the safety of exposure to it during the first trimester of pregnancy has not been assessed. In this study, we aimed to clarify the effects of exposure during the first trimester of pregnancy on maternal and fetal outcomes. Data were obtained from pregnant women who were counseled on drug use during pregnancy at two Japanese facilities from April 1988 to December 2017. The incidence of major malformations in singleton pregnancy was compared between neonates born to women who took cefcapene pivoxil hydrochloride (n = 270) and control drugs (n = 1594) during their first trimester. The adjusted odds ratio of the incidence of major malformations was calculated using multivariate logistic regression analysis adjusted for smoking during pregnancy and maternal age. The incidence of major malformations was 2.6% in the cefcapene pivoxil hydrochloride group and 1.8% in the control group. There were no significant differences in the incidence between the cefcapene pivoxil hydrochloride and control groups (adjusted odds ratio: 1.48 [95% confidence interval: 0.64-3.42], p = 0.36). This prospective cohort study showed that exposure to cefcapene pivoxil hydrochloride during the first trimester of pregnancy was not associated with increased risk of major malformations in infants. Our findings will help healthcare providers in choosing appropriate medicines.
盐酸头孢卡品匹酯是一种常用于孕妇或可能怀孕的女性的抗生素。然而，在妊娠早期接触它的安全性尚未得到评估。在这项研究中，我们旨在阐明妊娠早期暴露于它对母婴结局的影响。数据来自于 1988 年 4 月至 2017 年 12 月在日本的两家医疗机构接受妊娠用药咨询的孕妇。比较了在妊娠早期使用盐酸头孢卡品匹酯（n=270）和对照药物（n=1594）的单胎妊娠新生儿中主要畸形的发生率。使用多元逻辑回归分析调整了妊娠期间吸烟和母亲年龄等因素，计算了主要畸形发生率的调整优势比。在盐酸头孢卡品匹酯组和对照组中，主要畸形的发生率分别为 2.6%和 1.8%。两组之间的发生率无显著差异（调整后的优势比：1.48[95%置信区间：0.64-3.42]，p=0.36）。这项前瞻性队列研究表明，妊娠早期暴露于盐酸头孢卡品匹酯与婴儿主要畸形的风险增加无关。我们的研究结果将有助于医疗保健提供者选择合适的药物。
