Andersohn F, Garbe E
Universität Bremen, Bremen, BRD.
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2008 Oct;51(10):1135-44. doi: 10.1007/s00103-008-0648-9.
Over the years there has been an increase in the number of pharmacoepidemiological studies using secondary data from large health databases. Administrative health databases consist of data recorded within the health care system for reasons of billing. Physician-based databases use data derived from electronic medical records. In both types of databases, data are recorded prospectively and may include demographic information, lifestyle information, ambulatory consultations, drug prescriptions, ambulatory and in-hospital diagnoses, ambulatory services, laboratory values, hospitalizations and information on death. Health databases are valuable for research on drug utilization and drug effects, but they are also increasingly used for disease epidemiology studies. In recent years, most new drugs within the European Union have been approved with the requirement of active post-marketing surveillance for investigation of drug utilization or monitoring of drug safety. This implies an increasing need for valid data sources. Large health databases are important instruments for the detection of unknown drug risks and for the investigation of new safety signals derived from spontaneous reporting systems.
多年来，使用大型健康数据库中的二手数据进行的药物流行病学研究数量一直在增加。行政健康数据库由出于计费目的在医疗保健系统内记录的数据组成。基于医生的数据库使用从电子病历中获取的数据。在这两种类型的数据库中，数据都是前瞻性记录的，可能包括人口统计学信息、生活方式信息、门诊会诊、药物处方、门诊和住院诊断、门诊服务、实验室值、住院情况以及死亡信息。健康数据库对于药物利用和药物效果研究很有价值，但它们也越来越多地用于疾病流行病学研究。近年来，欧盟境内的大多数新药获批时都要求进行积极的上市后监测，以调查药物利用情况或监测药物安全性。这意味着对有效数据源的需求日益增加。大型健康数据库是检测未知药物风险以及调查来自自发报告系统的新安全信号的重要工具。
