美國食品藥品監(jiān)督管理局（FDA）于2020年6月發(fā)布了“醫(yī)院獲得性細(xì)菌性肺炎和呼吸機(jī)相關(guān)性細(xì)菌性肺炎：供企業(yè)用治療藥物開發(fā)指導(dǎo)原則”。該指導(dǎo)原則闡述了治療這類疾病的抗菌藥物臨床研究的一般原則和具體試驗(yàn)設(shè)計的建議。介紹該指導(dǎo)原則的主要內(nèi)容，期待對中國“醫(yī)院獲得性細(xì)菌性肺炎/呼吸機(jī)相關(guān)細(xì)菌性肺炎抗菌藥物臨床試驗(yàn)技術(shù)指導(dǎo)原則（征求意見稿）”的定稿和促進(jìn)這類藥物的研究有幫助。

FDA issued Hospital-Acquired Bacterial Pneumonia and VentilatorAssociated Bacterial Pneumonia:Developing Drugs for Treatment Guidance for Industry in June 2020. The guidance describes the general principles of clinical trials of antimicrobials for the treatment of these diseases and the recommendations for specific trial design. The guidance is introduced in detail. It is expected to contribute to the finalization of Technical guidelines for clinical trials of antimicrobials in hospital acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (Draft) and promoting the research of these drugs in China.