恢復期血漿治療Covid-19重症患者療效分析
作者：
小柯機器人發布時間：2020/11/26 10:58:12
阿根廷布宜諾斯艾利斯義大利醫院Ventura A. Simonovich團隊研究了恢復期血漿治療Covid-19重症患者的療效。2020年11月24日，該研究發表在《新英格蘭醫學雜誌》上。
基於大部分觀察數據，Covid-19患者經常使用恢復期血漿治療可改善臨床效果。但從足夠有力的隨機對照試驗中可獲得的數據較少。
研究組招募Covid-19重症成人住院患者，以2：1的比例隨機分配，其中228位接受恢復期血漿治療，105位接受安慰劑治療。主要結局是幹預後30天的患者臨床狀況，以六點序量表衡量，從完全恢復到死亡不等。參與者從症狀發作到入組的中位時間為8天，低氧血症是最常見的入組嚴重程度標準。患者輸注的恢復期血漿中總SARS-CoV-2抗體的平均滴度為1：3200，沒有患者失去隨訪。
第30天時，恢復期血漿組與安慰劑組之間的臨床結局分布無明顯差異。恢復期血漿組的總死亡率為10.96％，安慰劑組為11.43％，風險差異為-0.46個百分點。幹預後第2天，恢復期血漿組的SARS-CoV-2抗體滴度總體較高。兩組的不良事件和嚴重不良事件相似。
研究結果表明，採用恢復期血漿治療Covid-19患者，與安慰劑相比，並不能顯著改善臨床狀況或總體死亡率。
附：英文原文
Title: A Randomized Trial of Convalescent Plasma in Covid-19 Severe Pneumonia
Author: Ventura A. Simonovich, M.D.,, Leandro D. Burgos Pratx, M.D.,, Paula Scibona, M.D.,, María V. Beruto, M.D.,, Marcelo G. Vallone, M.D.,, Carolina Vázquez, M.D.,, Nadia Savoy, M.D.,, Diego H. Giunta, M.D., M.P.H., Ph.D.,, Lucía G. Pérez, M.D.,, Marisa del L. Sánchez, M.D.,, Andrea Vanesa Gamarnik, Ph.D.,, Diego S. Ojeda, Ph.D.,, Diego M. Santoro, M.D.,, Pablo J. Camino, M.D.,, Sebastian Antelo, M.D.,, Karina Rainero, M.D.,, Gabriela P. Vidiella, M.D.,, Erica A. Miyazaki, M.D.,, Wanda Cornistein, M.D.,, Omar A. Trabadelo, M.D.,, Fernando M. Ross, M.D.,, Mariano Spotti, M.D.,, Gabriel Funtowicz, M.D.,, Walter E. Scordo, M.D.,, Marcelo H. Losso, M.D.,, Inés Ferniot, M.D.,, Pablo E. Pardo, M.D.,, Eulalia Rodriguez, M.D.,, Pablo Rucci, M.D.,, Julieta Pasquali, M.D.,, Nora A. Fuentes, M.D.,, Mariano Esperatti, M.D., Ph.D.,, Gerardo A. Speroni, M.D.,, Esteban C. Nannini, M.D.,, Alejandra Matteaccio, M.D.,, Hernán G. Michelangelo, M.D.,, Dean Follmann, Ph.D.,, H. Clifford Lane, M.D.,, and Waldo H. Belloso, M.D.
Issue&Volume: 2020-11-24
Abstract:
BACKGROUND
Convalescent plasma is frequently administered to patients with Covid-19 and has been reported, largely on the basis of observational data, to improve clinical outcomes. Minimal data are available from adequately powered randomized, controlled trials.
METHODS
We randomly assigned hospitalized adult patients with severe Covid-19 pneumonia in a 2:1 ratio to receive convalescent plasma or placebo. The primary outcome was the patient’s clinical status 30 days after the intervention, as measured on a six-point ordinal scale ranging from total recovery to death.
RESULTS
A total of 228 patients were assigned to receive convalescent plasma and 105 to receive placebo. The median time from the onset of symptoms to enrollment in the trial was 8 days (interquartile range, 5 to 10), and hypoxemia was the most frequent severity criterion for enrollment. The infused convalescent plasma had a median titer of 1:3200 of total SARS-CoV-2 antibodies (interquartile range, 1:800 to 1:3200]. No patients were lost to follow-up. At day 30 day, no significant difference was noted between the convalescent plasma group and the placebo group in the distribution of clinical outcomes according to the ordinal scale (odds ratio, 0.83 (95% confidence interval [CI], 0.52 to 1.35; P=0.46). Overall mortality was 10.96% in the convalescent plasma group and 11.43% in the placebo group, for a risk difference of 0.46 percentage points (95% CI, 7.8 to 6.8). Total SARS-CoV-2 antibody titers tended to be higher in the convalescent plasma group at day 2 after the intervention. Adverse events and serious adverse events were similar in the two groups.
CONCLUSIONS
No significant differences were observed in clinical status or overall mortality between patients treated with convalescent plasma and those who received placebo.
DOI: 10.1056/NEJMoa2031304
Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2031304