Department of Anatomy, School of Medicine, University of Novi Sad, Novi Sad, Serbia.
Eur Rev Med Pharmacol Sci. 2012 Jan;16(1):103-10.
During pregnancy, a number of changes occur in women's body, and some medications are safe and some are not. The aim of our study was to establish the possible correlation between use of beta-lactam antibiotics in pregnancy and occurrence of congenital malformations.
The study included 893 pregnant women from Zagreb and 6099 pregnant women from Novi Sad. 527 pregnant women used beta-lactams. First part of the study (one month study) was performed at four maternity hospitals in Zagreb, Croatia. Second part were collected as a part of the study analysing the teratogenicity of drugs used in pregnancy, a longitudinal study performed in Novi Sad district.
Pregnant women most frequently used antibacterial agents in the first trimester of pregnancy. They used 15 different antibacterial medications, most often beta-lactams. In Zagreb arm, out of the total number of pregnant women that used medications during pregnancy (859), 231 (26.9%) used beta-lactam antibiotics. Malformations were detected in 8 (3.5%) cases. The prevalence of malformations in newborns whose mothers did not take beta-lactam antibiotics in pregnancy (662) was 2.7% (18 newborns with malformations). In Novi Sad arm, out of the total number of pregnant women that used medications during pregnancy (2013), 296 (14.7%) used beta-lactam antibiotics. Malformations were detected in 14 (4.7%) cases. The prevalence of malformations in newborns whose mothers did not take beta-lactam antibiotics in pregnancy (5803) was 1.7% (99 newborns with malformations).
The results show possible teratogenic potential even with those antibacterials which are considered safe (amoxicillin) but as those are usually minor malformations they often pass undetected. International pharmacoepidemiological studies of drug use in pregnancy could substantially contribute to the improvement of pharmacotherapy, and could be of great help in assessing the fetal risks.
怀孕期间，女性的身体会发生多种变化，一些药物是安全的，而一些则不安全。我们的研究旨在确定孕妇使用β-内酰胺类抗生素与先天性畸形发生之间的可能相关性。
该研究包括来自萨格勒布的 893 名孕妇和来自诺维萨德的 6099 名孕妇。527 名孕妇使用了β-内酰胺类抗生素。研究的第一部分（一个月的研究）在克罗地亚萨格勒布的四家妇产医院进行。第二部分作为分析怀孕期间使用的药物致畸性的研究的一部分收集，这是在诺维萨德区进行的一项纵向研究。
孕妇在怀孕的第一个月最常使用抗菌药物。她们使用了 15 种不同的抗菌药物，最常用的是β-内酰胺类药物。在萨格勒布组中，在怀孕期间使用药物的孕妇总数（859 名）中，有 231 名（26.9%）使用了β-内酰胺类抗生素。在 8 例（3.5%）中检测到畸形。在未服用β-内酰胺类抗生素的孕妇所生新生儿（662 例）中，畸形的患病率为 2.7%（18 例有畸形的新生儿）。在诺维萨德组中，在怀孕期间使用药物的孕妇总数（2013 名）中，有 296 名（14.7%）使用了β-内酰胺类抗生素。在 14 例（4.7%）中检测到畸形。在未服用β-内酰胺类抗生素的孕妇所生新生儿（5803 例）中，畸形的患病率为 1.7%（99 例有畸形的新生儿）。
研究结果表明，即使是那些被认为安全的抗菌药物（阿莫西林）也可能具有致畸潜力，但由于这些药物通常是轻微的畸形，因此往往无法被发现。国际药物流行病学研究药物在怀孕期间的使用可以极大地促进药物治疗的改善，并在评估胎儿风险方面提供很大帮助。
