FDA官網(wǎng)新聞發(fā)布：

2020年4月10日，美國(guó)食品和藥物管理局發(fā)布了一項(xiàng)血液凈化系統(tǒng)的EUA（應(yīng)急使用授權(quán)），用于治療已確診患有2019冠狀病毒(COVID-19)的18歲或18歲以上的患者，該病人是已確診或即將出現(xiàn)呼吸衰竭，被送往重癥監(jiān)護(hù)病房(ICU)的患者。

該授權(quán)產(chǎn)品通過(guò)減少細(xì)胞因子和其他炎癥介質(zhì)的數(shù)量起作用，即血液中控制細(xì)胞免疫反應(yīng)的小分子活性蛋白，通過(guò)過(guò)濾血液并將過(guò)濾后的血液返回給病人。被移除的蛋白質(zhì)通常在感染期間升高，可能與在某些COVID-19患者身上出現(xiàn)的“細(xì)胞因子風(fēng)暴”有關(guān)，導(dǎo)致嚴(yán)重炎癥，迅速進(jìn)展性休克，呼吸衰竭，器官衰竭和死亡。

FDA專員斯蒂芬·M·哈恩(Stephen M.Hahn)說(shuō)：“我們繼續(xù)在各個(gè)部門(mén)開(kāi)展工作，加快開(kāi)發(fā)許多具有創(chuàng)新潛力的預(yù)防措施和治療方法，通過(guò)這兩項(xiàng)緊急促進(jìn)措施，為病人緊急治療提供便利，在我們力所能及的范圍內(nèi)，支持對(duì)潛在療法的評(píng)估。隨著今天血液凈化設(shè)備的授權(quán)，我們正在加快為重癥監(jiān)護(hù)病房的病人提供治療方案，以幫助減輕疾病的嚴(yán)重程度。我們的工作人員將繼續(xù)對(duì)所有醫(yī)療產(chǎn)品進(jìn)行全天候的審查，加快提供治療，幫助抗擊這一毀滅性疾病。”

Terumo BCT公司的Spectra Optia單采血液分離系統(tǒng)與Marker Therapeutics公司生產(chǎn)的Depuro D2000吸附盒配合使用，獲得該項(xiàng)FDA的緊急使用授權(quán)。

原文譯自FDA：

The U.S. Food and Drug Administration issued an emergency use authorization for a blood purification system to treat patients 18 years of age or older with confirmed Coronavirus Disease 2019 (COVID-19) admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure.

The authorized product works by reducing the amount of cytokines and other inflammatory mediators, i.e., small active proteins in the bloodstream that control a cell’s immune response by filtering the blood and returning the filtered blood to the patient. The proteins that are removed are typically elevated during infections and can be associated with a “cytokine storm” that occurs in some COVID-19 patients, leading to severe inflammation, rapidly progressive shock, respiratory failure, organ failure and death.

“We continue to work across all sectors to expedite the development of numerous innovative potential preventive and treatment approaches by both facilitating emergency access for patients, to the extent we can, and supporting the evaluation of potential therapies,” said FDA Commissioner Stephen M. Hahn, M.D. “With today’s authorization of a blood purification device, we are expediting the availability of a treatment option for patients in the ICU to help reduce the severity of the disease. Our staff will continue our around the clock review of all medical products to expedite the availability of treatments to help fight this devastating disease.”

The FDA issued this emergency use authorization to Terumo BCT Inc. and Marker Therapeutics AG for their Spectra Optia Apheresis System and Depuro D2000 Adsorption Cartridge devices.