Use of cephalosporins during pregnancy and in the presence of congenital abnormalities: A population-based, case-control study
Use of cephalosporins during pregnancy and in the presence of congenital abnormalities: A population-based, case-control study
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DOI：
10.1067/mob.2001.113905
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发表时间：
2001-05-01
影响因子：
9.8
通讯作者：
Olsen, J
中科院分区：
文献类型：
--
作者：
Czeizel, AE;Rockenbauer, M;Olsen, J
目的：研究妊娠期头孢菌素治疗对人类致畸作用。研究设计：对先天畸形患者和无先天异常的配对对照进行配对分析。使用的是1980-1996年匈牙利先天畸形病例对照监测的人口数据集。研究对象包括22865名有先天畸形的胎儿或新生儿，38151名无先天缺陷的孕妇(人口对照组)，812名唐氏综合征产妇(对照组)。结果：病例组有308名孕妇(1.35%)接受头孢菌素治疗。在人群组和患者对照组中，440名(1.15%)和16名(1.97%)孕妇接受了类似的治疗。在病例组和患者对照组中，头孢菌素类药物的使用率较高，主要是口服头孢氨苄，这可以用回忆偏差来解释。不同先天畸形组在妊娠第2~3个月期间使用头孢菌素治疗的发生率与总人口对照组和患者对照组的参考数据进行比较，并未表明研究药物在人类可检测到的致畸潜力。结论：妊娠期使用头孢菌素类药物似乎不会对胎儿产生可检测到的致畸风险。然而，需要进一步的研究来分别阐明不同头孢菌素的致畸和胎儿毒性作用。
OBJECTIVE: Our purpose was to study the human teratogenic potential of cephalosporin treatment during pregnancy.STUDY DESIGN: Pair analysis of cases with congenital abnormalities and matched controls without congenital abnormalities was performed. The population-based data set of the Hungarian Case-Control Surveillance of Congenital Abnormalities, 1980-1996, was used. The participants included 22,865 pregnant women who had fetuses or newborn infants with congenital abnormalities, 38,151 pregnant women who had infants without any defects (population control group), and 812 mothers who were delivered of babies affected with Down syndrome (patient controls).RESULTS: In the case group, 308 (1.35%) pregnant women were treated with cephalosporin. In the population and patient control groups, 440 (1.15%) and 16 (1.97%) pregnant women had similar treatments. The somewhat higher use of cephalosporins, mainly oral cephalexin, in the case and patient control groups was explained by recall bias. The comparison of the occurrence of medically documented cephalosporin treatments during the second to third months of gestation tie, the critical period for major congenital abnormalities) in different congenital abnormality groups with the referent data of the total population control group and the patient control group did not indicate a detectable human teratogenic potential of the studied drug.CONCLUSION: Treatment with the studied cephalosporins during pregnancy does not seem to present a detectable teratogenic risk to the fetus. However, further studies are needed to clarify the teratogenic and fetal toxic effects of different cephalosporins separately.