美國食品藥品管理局（FDA）于2021年12月發(fā)布了"慢性鼻-鼻竇炎伴鼻息肉：開發(fā)治療藥物供企業(yè)用的指導原則草案"，對慢性鼻-鼻竇炎伴鼻息肉（CRSwNP）治療藥物臨床研究的試驗人群、設計、有效性、安全性和統(tǒng)計分析提出了許多建議，內(nèi)容具體、詳細，而且便于實際操作。中國目前沒有類似的指導原則，詳細介紹FDA該指導原則，期待對我國這類藥物的臨床研究及其監(jiān)管有直接的參考價值，對制定類似的臨床研究指導原則有所啟迪。

Food and Drug Administration (FDA) issued the Chronic Rhinosinusitis with Nasal Polyps:Developing Drugs for Treatment Draft Guidance for Industry in December 2021. Many suggestions are put forward on the trial population, design, effectiveness, safety and statistical analysis of the clinical research of drugs for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP). The content is specific, detailed and convenient for practical operation. At present, there is no similar guidance in China. The guidance of FDA is introduced in detail, which is expected to have direct reference value for the clinical research and supervision of this kind of drugs in China, and also enlighten the formulation of similar guidance for clinical research in China.

R951