美國食品和藥品監(jiān)督管理局（FDA）于2014年3月發(fā)布了“慢性疲勞綜合癥/肌痛性腦脊髓炎（CFS/ME）指南草案”。指南草案介紹CFS/ME的臨床癥狀，嚴(yán)重的CFS/ME影響患者的工作、學(xué)習(xí)和日常生活。目前CFS/ME的診斷比較困難，也沒有任何有效藥物獲批用于該病的治療，CFS/ME已成為遠(yuǎn)未得到滿足的公眾健康問題。在草案中，F(xiàn)DA從藥物的臨床試驗設(shè)計等多方面，如目標(biāo)人群定位、療效終點、安全性等來指導(dǎo)相關(guān)新藥的研發(fā)。介紹了指南的主要內(nèi)容，期望為我國這方面的臨床試驗及藥物的開發(fā)提供參考。

The US Food and Drug Administration (FDA) issues "Guidance for Industry Chronic Fatigue Syndrome (CFE)/Myalgic Encephalomyelitis (ME): Developing Drug Products for Treatment" in March 2014. Clinical syndromes were contained in the draft guidance. CFS/ME affects the function in daily activities of work, school, household management, and personal care of patients. Currently CFS/ME is a serious disease and there are no approved therapies to treat CFS/ME, which is unmet medical need in the treatment. The guidance focused on specific drug development and clinical trials design issues is drafted, which contain drug development population, efficacy points, and safety etc. This article describes the main contents of the guidelines, expected to provide a reference for the development of this aspect of clinical trials and drug.