药品风险信号的发现与上市后研究

Identifying risk signals and clinical studies of post-marketing drugs

分析美国FDA发现药品安全风险的途径,分析和阐述药品上市后研究的地位和作用。通过检索美国FDA网站,收集和分析美国FDA针对专业医生发布的药品安全性信息和信息来源。结果发现,2004-2009年美国FDA告知专业医生新发现的药品严重安全性问题,共涉及46种或类药物。药品安全性问题多数是通过自发报告系统、临床对照试验及病例对照和队列研究发现的。药品上市后研究,是评价药品安全风险的必要手段,药品安全性问题应依靠多种研究方法互补,才能获得相对充分的证据,降低临床用药风险。

To analyze the approaches used by US FDA for identifying risk signals of medicines and explain the roles of clinical studies on post-marketing drugs.US FDA website were searched and analyzed regarding safety information on drugs for healthcare professionals and safety information resources.During 2005 and 2009,safety information on drugs for healthcare professionals released by US FDA is involved in 46 classes of medicines which most of identified risk signals are based on post-marketing reports,clinical control trials,case control studies and cohort studies.Clinical study of post-marketing drug is the necessary method to identify and assess safety profile of medicine.For obtaining relatively adequate evidence,safety profile of medicine should rely on multiple information resources in order to have a good understanding on safety profile of medicine and avoid drug risk.