Czeizel A E, Rockenbauer M, Olsen J, Sørensen H T
Foundation for the Community Control of Hereditary Diseases, National Center for Epidemiology, Budapest, Hungary.
Scand J Infect Dis. 2000;32(3):309-13. doi: 10.1080/00365540050165974.
The aim of this study was to investigate the teratogenicity of aminoglycoside antibiotics, such as parenteral gentamicin, streptomycin, tobramycin and oral neomycin, during pregnancy. Pair analysis of cases with congenital abnormalities and matched healthy controls was carried out. The setting was the population-based dataset of the Hungarian Case-Control Surveillance of Congenital Abnormalities, 1980-96. In total, 38,151 pregnant women who had newborn infants without any defects (control group) and 22,865 pregnant women who had foetuses or newborns with congenital abnormalities were included in the study. 38 (0.16%) and 42 (0.11%) pregnant women in the case and control groups, respectively, were treated with the aminoglycosides studied. A teratogenic potential of gentamicin and neomycin was not indicated by a comparison of the occurrence of aminoglycoside antibiotic treatments in the total control group as referent with the figures of different congenital abnormality groups. In addition, the case-control pair analysis during the second-third months of pregnancy did not show a teratogenic risk of gentamicin and neomycin. The conclusion of this study is that treatment with parenteral gentamicin and oral neomycin during pregnancy presents no detectable teratogenic risk to the foetus, when restricted to structural developmental disturbances.
本研究旨在调查孕期使用氨基糖苷类抗生素(如注射用庆大霉素、链霉素、妥布霉素以及口服新霉素)的致畸性。对先天性异常病例与匹配的健康对照进行配对分析。研究数据来自1980 - 1996年匈牙利先天性异常病例对照监测的基于人群的数据集。该研究共纳入了38151名新生儿无任何缺陷的孕妇(对照组)以及22865名胎儿或新生儿患有先天性异常的孕妇。病例组和对照组分别有38名(0.16%)和42名(0.11%)孕妇接受了所研究的氨基糖苷类药物治疗。以整个对照组作为参照,比较不同先天性异常组中氨基糖苷类抗生素治疗的发生率,未显示庆大霉素和新霉素有致畸潜能。此外,孕期第二至三个月的病例对照配对分析也未显示庆大霉素和新霉素有致畸风险。本研究的结论是,孕期使用注射用庆大霉素和口服新霉素,若仅限于结构发育障碍,对胎儿无明显致畸风险。