Schaefer Christof, Ornoy Asher, Clementi Maurizio, Meister Reinhard, Weber-Schoendorfer Corinna
Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie (BBGes), Berlin Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy, Spandauer Damm 130, Haus 10, 14050 Berlin, Germany.
Reprod Toxicol. 2008 Sep;26(1):36-41. doi: 10.1016/j.reprotox.2008.05.064. Epub 2008 Jun 7.
Clinical data are urgently needed to specify the risk and safety of drug use during pregnancy. For several reasons pregnant women are usually excluded from clinical studies. Therefore, observational data are the main source of knowledge, cohort studies as well as case-control studies. Disadvantages of cohort studies based on observational data have been repeatedly discussed. However, being involved in individual risk characterisation of pregnant women it is the experience of clinical teratologists that even reports on small cohorts should not be disregarded if no other data are available. The recently published "Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement" underlines the value of observational data and provides a checklist regarding the most important inherent methodological problems. Our article describes how Teratology Information Services (TIS) document and evaluate their observations on pregnant women exposed to various drugs and discusses methodological problems and--considering the STROBE statement--how these could be addressed.
临床数据对于明确孕期用药的风险和安全性至关重要。由于多种原因，孕妇通常被排除在临床研究之外。因此，观察性数据是主要的知识来源，包括队列研究和病例对照研究。基于观察性数据的队列研究的缺点已被反复讨论。然而，鉴于临床致畸学家参与孕妇个体风险特征分析的经验，即使是关于小队列的报告，如果没有其他可用数据，也不应被忽视。最近发表的《加强流行病学观察性研究报告（STROBE）声明》强调了观察性数据的价值，并提供了一份关于最重要的固有方法学问题的清单。我们的文章描述了致畸学信息服务（TIS）如何记录和评估他们对接触各种药物的孕妇的观察结果，并讨论了方法学问题，以及——考虑到STROBE声明——如何解决这些问题。
