Therapie. 2014 Jan-Feb;69(1):83-9. doi: 10.2515/therapie/2014007. Epub 2014 Apr 4.
Medicine use during pregnancy is common; however the safety of medicine use during pregnancy is largely unknown when a medicine comes to market. Electronic healthcare databases, including the Clinical Practice Research Datalink (CPRD), are increasingly being used for post-marketing surveillance in this field. The CPRD contains anonymised, longitudinal medical records routinely collected in primary care. Using CPRD data it is possible to identify medical records indicative of pregnancy, including pregnancy losses. Data on prescriptions issued can be used to determine maternal exposure and for about 80% of pregnancies it is possible to link the mother's medical record to the medical record of the child. Data in the medical records of the mother and child can then be used to identify adverse pregnancy outcomes, including congenital malformations. This paper describes some of the complexities involved in using CPRD data for pregnancy related research and discusses some of its strengths and limitations.
孕期用药较为常见；然而，当一种药物上市时，其在孕期使用的安全性在很大程度上仍是未知的。电子医疗保健数据库，包括临床实践研究数据链（CPRD），越来越多地被用于该领域的上市后监测。CPRD 包含在初级保健中常规收集的匿名、纵向医疗记录。使用 CPRD 数据，可以识别出表明怀孕的医疗记录，包括妊娠丢失。开出的处方数据可用于确定产妇暴露情况，大约 80%的妊娠可以将母亲的医疗记录与孩子的医疗记录联系起来。然后，可以使用母亲和孩子的医疗记录中的数据来识别不良妊娠结局，包括先天性畸形。本文描述了使用 CPRD 数据进行与妊娠相关的研究所涉及的一些复杂性，并讨论了其一些优势和局限性。
