Department of Public Health, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.
J Clin Pharmacol. 2013 Sep;53(9):991-5. doi: 10.1002/jcph.139. Epub 2013 Jul 20.
Antibacterial drugs are among the most common medications used by pregnant women. While medical literature generally defines nitrofurantoin as an antibiotic that is safe for use during the first trimester of pregnancy, new concerns about a possible association between congenital malformations following exposure to nitrofurantoin during the first trimester of pregnancy have recently surfaced. To address these concerns, we conducted a large population-based retrospective cohort study to assess this possible association (including cases of medical terminations of pregnancy or stillbirth) and congenital malformations. A computerized database for medications dispensed to pregnant women in southern Israel was linked with records from the district hospital. Associations between exposure to nitrofurantoin during the first trimester and major malformations were assessed. Our research included a total of 105,492 pregnancies, 1,112 of which involved pregnancy terminations for medical reasons. A total of 1,329 infants and abortuses had been exposed to nitrofurantoin during the first trimester of pregnancy. Exposure to nitrofurantoin was not associated with increased risk of major malformations in general (adjusted OR = 0.85, 95% CI 0.67-1.08) or with specific malformations. First trimester exposure to nitrofurantoin was not associated with increased risk for total major congenital malformations or with specific malformations.
抗菌药物是孕妇最常用的药物之一。尽管医学文献通常将呋喃妥因定义为在妊娠早期使用安全的抗生素，但最近新出现了一种担忧，即妊娠早期接触呋喃妥因可能与先天畸形之间存在关联。为了解决这些担忧，我们进行了一项大规模的基于人群的回顾性队列研究，以评估这种可能的关联（包括因医疗原因终止妊娠或死产的病例）和先天畸形。以色列南部的一个孕妇用药计算机数据库与地区医院的记录相连接。评估了妊娠早期接触呋喃妥因与重大畸形之间的关联。我们的研究共包括 105492 例妊娠，其中 1112 例因医疗原因终止妊娠。共有 1329 名婴儿和流产胎儿在妊娠早期接触过呋喃妥因。接触呋喃妥因与重大畸形的总体风险增加无关（调整后的 OR = 0.85，95%CI 0.67-1.08），也与特定畸形无关。妊娠早期接触呋喃妥因与总重大先天性畸形或特定畸形的风险增加无关。
