国外关于“沙利度胺”重新评价的启示

Overview of Thalidomide Revaluation and Approval in the Developed Countries

沙利度胺(酞咪哌啶酮,Thalidomide,TLD),俗称反应停,二十世纪六十年代因其生殖毒性被撤出临床。本文依据国内外的相关文献,对沙利度胺的新治疗领域及临床价值进行了总结。重点介绍了国外药品监管机构对该药临床价值的重新评价批准结果、如何通过设立限制性临床使用条件等措施规避该类毒性药物的风险,发挥已知明确毒性的药物新临床治疗价值的管理策略,阐述了对我国药品研究机构和管理机构的启示作用。

Thalidomide (TLD) is famous for its genetic toxicity.During the past forty years,it was hardly used in clinical medi- cation.In recent years,U.S.FDA,EMEA and other country's drug administration agencies in the developed countries began to au- thorize TLD marketing with new indication.In order to avoide the risk of TLD in clinical use.all agencies set up a series of ap- proval limitative condition.Based on study outcomes analysis and approval process analysis,the author proposed some suggestions for improving research and regulatory system for drugs with confirmed toxicity in our country.