必须关注药品上市后的再评价

Necessity of Post - Marketing Drug Surveillance

20世纪是药物大发展时期,各类新药层出不穷,但所致之不良反应也十分严重。据估计,在美国即使正确使用已上市的药品,因严重药物不良反应的死亡率,仍然占十个致死原因之首,也是住院患者死亡原因的第五位。其重要原因之一是新药在上市前的实验研究受到多种因素限制,如病例少、时间短、观察对象和终点范围狭窄等,致使很难预测一些少见的严重不良反应并提出相应的警告。文章列举了近20年、尤其是近一年内从市场上撤除的新药及其原因,建议应加强上市前的临床试验和药物不良反应自动报告系统,强调有必要认真做好新药上市后的临床观察、医疗记录、及药物流行病学的计算机数据库,建立完善的药物监察系统。医务人员在预防重大药物不良反应事件中,具有不可推卸的责任。

The 20th century is the period with dramatic increase in drug research and development. However, the occurrence of adverse drug events ( ADR ) is becoming worse and worse. It was estimated that the death rate caused by ADR is on the top of the ten leading reasons, and ranks the fifth reason for the death of hospitalized patients. Many elements may limit the experiment research of new drugs before marketing, e.g., short of time, limited observation objects and case number, narrow end - points, etc. Such serious status makes it difficult to predict those rare ADRs and to warn in advance. Those drugs withdrawn after marketing in the past 20 years were analyzed here regarding their causes and risks. It suggested here that the clinical trials pre- marketing and the auto- reporting system of ADR should be strengthened. It emphasized the necessity of clinical observations and medical records for those post - marketing new drugs. It also emphasized the importance to set up a post - marketing drug surveillance system and to build the database of pharrnaco- epidemicology. Health care providers play major roles in the prevention of ADR.