問題詳情
四、請閱讀下列文章,並使用中文回答相關的問題:(本大題未使用中文回答,酌予扣分)(40%) Severe primary graft dysfunction (PGD) of grade 3 (PGD3) is a common seriouscomplication following lung transplantation. We aimed to assess physiological donor lungpreservation using the Organ Care System (OCS) Lung device compared with cold static storage.In this non-inferiority, randomized, controlled, open-label, phase 3 trial (INSPIRE) recipientswere aged 18 years or older and were registered as standard criteria primary double lungtransplant candidates. Eligible donors were younger than 65 years old with a ratio of partialpressure of oxygen in arterial blood to the fraction of inspired oxygen of more than 300 mm Hg.Transplant recipients were randomly assigned (1:1) with permuted blocks, stratified by center, toreceive standard criteria donor lungs preserved in the OCS Lung device (OCS arm) or coldstorage at 4C (control arm). The composite primary effectiveness endpoint was absence of PGD3within the first 72 h after transplant and 30-day survival in the per-protocol population, with astringent 4% non-inferiority margin. Superiority was tested upon meeting non-inferiority. Theprimary safety endpoint was the mean number of lung graft-related serious adverse events within30 days of transplant.
【題組】(4-1)請描述此研究之目的(10%)
參考答案
答案:C
難度:計算中-1
書單:沒有書單,新增
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