若干处方药撤出市场的回顾与思考

• 作 者: 张石革
• 机 构: 北京积水潭医院 北京 100035
• 出 处: 药物不良反应杂志
• 发表日期: 2002年01期
• 关键词: 处方药 不良反应 市场 教训与思考

由于市场效益和临床需求的驱动,对新药的结构修饰或新化学单体的开发异常迅猛。但鉴于新药上市审批程序的缺陷和生产前临床试验病例数量的限制,近年来为数不少的新药相继被发现有严重的不良反应而退出市场,上市和撤出货架的间隔周期也日趋缩短。因此,临床医师和药师应慎重地选择和合理应用新药。另对新药评价和上市后监测的模式也尚待我们思考。

Driven by market efficiency and clinical needs, the structural modification of new drugs or the development of new chemical monomers are unusually rapid. However, in view of the defects in the examination and approval procedures for new drugs and the limited number of clinical trials before production, quite a number of new drugs have been found to have serious adverse reactions in recent years to withdraw from the market and the intervals between listing and withdrawal of shelves have also been shortened. Therefore, clinicians and pharmacists should carefully choose and rational use of new drugs. Another new drug evaluation and post-marketing monitoring model has yet to be our thinking.