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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 (Thalidomide, TLD), commonly known as the reaction stopped in the 1960s due to its reproductive toxicity was withdrawn from the clinic. Based on the relevant literature at home and abroad, this article summarizes the new therapeutic field and clinical value of thalidomide. It mainly introduces the result of the re-evaluation and approval of the clinical value of the drug by the foreign drug regulatory agencies, how to avoid the risk of such toxic drug through the establishment of restrictive clinical conditions, and to play a management strategy of the new clinical value of the drug with known specific toxicity , Expounded the enlightenment to China’s pharmaceutical research institutions and regulatory agencies.