恢复期血浆抗体水平与新冠死亡风险。
Convalescent Plasma Antibody Levels and the Risk of Death from Covid-19.
机构信息
From the Departments of Anesthesiology and Perioperative Medicine (M.J.J., J.W.S., S.A.K., C.C.W., A.M.K., M.A.S., J.C.D.S., S.E.B., J.R.A.S., V.H., A.J.C., J.G.R., K.J.A., M.N.P.V., J.J.D., R.J.R.), Laboratory Medicine and Pathology (J.R.M., E.S.T., C.M.B., J.L.W., J.R.S.), and Cardiovascular Medicine (R.F.R., K.F.L., R.S.W.), the Human Research Protection Program (R.S.W.), and the Department of Internal Medicine, Division of Pulmonary and Critical Care Medicine (P.R.B.), Mayo Clinic, Rochester, MN; the Departments of Health Sciences Research (R.E.C., P.W.J., E.R.L., D.O.H.) and Cardiovascular Medicine (K.A.B., E.R.W., D.F.), Mayo Clinic, Jacksonville, FL; the Department of Health Sciences Research (K.L.K., M.R.B.) and the Department of Internal Medicine, Division of Infectious Diseases (J.E.B.), Mayo Clinic, Phoenix, AZ; the Department of Anesthesiology, Cooper Medical School of Rowan University, Cooper University Health Care, Camden, NJ (N.H.); the Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring (N.C.V., P.M.), and the Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore (A.C.) - both in Maryland; and the Departments of Epidemiology and Biostatistics and of Pediatrics and Human Development, College of Human Medicine, Michigan State University, East Lansing (N.S.P.).
出版信息
N Engl J Med. 2021 Mar 18;384(11):1015-1027. doi: 10.1056/NEJMoa2031893. Epub 2021 Jan 13.
BACKGROUND
Convalescent plasma has been widely used to treat coronavirus disease 2019 (Covid-19) under the presumption that such plasma contains potentially therapeutic antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that can be passively transferred to the plasma recipient. Whether convalescent plasma with high antibody levels rather than low antibody levels is associated with a lower risk of death is unknown.
METHODS
In a retrospective study based on a U.S. national registry, we determined the anti-SARS-CoV-2 IgG antibody levels in convalescent plasma used to treat hospitalized adults with Covid-19. The primary outcome was death within 30 days after plasma transfusion. Patients who were enrolled through July 4, 2020, and for whom data on anti-SARS-CoV-2 antibody levels in plasma transfusions and on 30-day mortality were available were included in the analysis.
RESULTS
Of the 3082 patients included in this analysis, death within 30 days after plasma transfusion occurred in 115 of 515 patients (22.3%) in the high-titer group, 549 of 2006 patients (27.4%) in the medium-titer group, and 166 of 561 patients (29.6%) in the low-titer group. The association of anti-SARS-CoV-2 antibody levels with the risk of death from Covid-19 was moderated by mechanical ventilation status. A lower risk of death within 30 days in the high-titer group than in the low-titer group was observed among patients who had not received mechanical ventilation before transfusion (relative risk, 0.66; 95% confidence interval [CI], 0.48 to 0.91), and no effect on the risk of death was observed among patients who had received mechanical ventilation (relative risk, 1.02; 95% CI, 0.78 to 1.32).
CONCLUSIONS
Among patients hospitalized with Covid-19 who were not receiving mechanical ventilation, transfusion of plasma with higher anti-SARS-CoV-2 IgG antibody levels was associated with a lower risk of death than transfusion of plasma with lower antibody levels. (Funded by the Department of Health and Human Services and others; ClinicalTrials.gov number, NCT04338360.).
背景
恢复期血浆已被广泛用于治疗 2019 年冠状病毒病（COVID-19），其假设是该血浆中含有可能对严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）具有治疗作用的抗体，这些抗体可以被动转移到血浆接受者。抗体水平较高的恢复期血浆与较低的死亡风险相关，而不是抗体水平较低，这一点尚不清楚。
方法
本研究基于美国国家注册中心进行了一项回顾性研究，我们确定了用于治疗 COVID-19 住院成人的恢复期血浆中的抗 SARS-CoV-2 IgG 抗体水平。主要结局是血浆输注后 30 天内死亡。我们纳入了 2020 年 7 月 4 日之前通过登记入组的患者，且这些患者的血浆输注抗 SARS-CoV-2 抗体水平和 30 天死亡率数据齐全。
结果
在这项分析中，3082 例患者中，在高滴度组的 515 例患者中有 115 例（22.3%）、在中滴度组的 2006 例患者中有 549 例（27.4%）和在低滴度组的 561 例患者中有 166 例（29.6%）在血浆输注后 30 天内死亡。抗 SARS-CoV-2 抗体水平与 COVID-19 死亡风险之间的关联受机械通气状态的影响。与低滴度组相比，在未接受机械通气的患者中，高滴度组在 30 天内死亡的风险较低（相对风险为 0.66；95%置信区间[CI]为 0.48 至 0.91），而在接受机械通气的患者中，机械通气对死亡风险无影响（相对风险为 1.02；95%CI 为 0.78 至 1.32）。
结论
在未接受机械通气的 COVID-19 住院患者中，输注抗 SARS-CoV-2 IgG 抗体水平较高的血浆与较低的死亡风险相关，而不是输注抗体水平较低的血浆。（由美国卫生与公众服务部等资助；ClinicalTrials.gov 编号，NCT04338360。）
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