Weiss S R, Cooke C E, Bradley L R, Manson J M
Department of Pharmacy Practice and Science, School of Pharmacy, University of Maryland, Baltimore 21201, USA.
J Am Pharm Assoc (Wash). 1999 Nov-Dec;39(6):830-4.
To introduce the concept and design characteristics of pregnancy registries and to discuss opportunities for pharmacist involvement.
Previous and ongoing pregnancy registry studies that assess the safety of pharmaceutical agents in pregnant women were identified from the medical literature, Internet, abstracts from professional meetings, and personal communications.
The development and use of the pregnancy registry study for evaluating drug safety is described. Then, to illustrate the application of scientific principles to this unique study design, examples are given from previous and ongoing pregnancy registry studies.
Pregnancy registry studies are increasingly used to assess the safety of drugs and other therapeutic agents during pregnancy. In a pregnancy registry, women who took the study drug while pregnant are identified soon after that exposure and followed until their pregnancy ends and its outcome is determined. Information is compiled from hundreds or thousands of pregnancies and used to make a safety assessment.
Pharmacists can explain pregnancy registries to pregnant women and encourage enrollment. Also, pharmacists can use information derived from these studies to help patients and health care providers manage inadvertent drug exposures and optimize pharmaceutical therapy during pregnancy.
介绍妊娠登记处的概念和设计特点，并讨论药剂师参与的机会。
从医学文献、互联网、专业会议摘要和个人交流中识别出以往和正在进行的评估孕妇药物安全性的妊娠登记研究。
描述了用于评估药物安全性的妊娠登记研究的开展和使用情况。然后，为说明科学原理在这种独特研究设计中的应用，列举了以往和正在进行的妊娠登记研究的实例。
妊娠登记研究越来越多地用于评估孕期药物和其他治疗剂的安全性。在妊娠登记处，孕期服用研究药物的女性在暴露后不久即被识别出来，并进行跟踪，直至妊娠结束并确定其结局。收集来自数百或数千例妊娠的信息并用于进行安全性评估。
药剂师可以向孕妇解释妊娠登记处的情况并鼓励其登记。此外，药剂师可以利用这些研究得出的信息，帮助患者和医疗保健提供者处理意外的药物暴露情况，并在孕期优化药物治疗。
