Tse Kevin, Chen Qiaoling, Padilla Ariadna, Martinez Kenneth, Salazar Alejandra, Aidikoff Jennifer, Soliven Stephanie, Sintef Ann, Palmer-Toy Darryl, Platz Brian, Shafi Hedyeh, Zemek Allison
Department of Allergy and Immunology, Southern California Permanente Medical Group, San Diego Kaiser Permanente Medical Center, San Diego, Calif.
Department of Research and Evaluation, Southern California Permanente Medical Group, Pasadena, Calif.
J Allergy Clin Immunol Glob. 2022 Nov;1(4):309-311. doi: 10.1016/j.jacig.2022.07.003. Epub 2022 Aug 23.
In April 2020, the Mayo Clinic helped establish the US Food and Drug Administration Expanded Access Protocol for COVID-19 (coronavirus disease 2019) convalescent plasma (CCP). The effectiveness of CCP in the published literature is contradictory because some retrospective studies showed benefit in reducing mortality and severe illness, whereas prospective randomized controlled trials demonstrated no benefit of CCP.
To discuss (1) the implementation of CCP across Kaiser Permanente Southern California between April 2020 and April 2021, (2) retrospective multivariable analysis of 2,831 patients with COVID-19 who were transfused with CCP compared with 18,475 patients with COVID-19 who did not receive CCP, (3) how to reconcile contradictory published data regarding the efficacy of CCP, and (4) guidance regarding the future use of convalescent plasma in a large community hospital setting.
Multivariable analysis was controlled for demographic characteristics, level of oxygen delivery, intensive care unit stay, selected laboratory findings, and other concurrent treatment-related variables. Tubing segments from 151 CCP units transfused between October 2020 and April 2021 were retrospectively tested for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) anti-spike protein receptor-binding domain IgG. Multivariable analysis showed that CCP transfusion did not affect mortality rates at 30 days and 5 months (odds ratio, 1.04, 95% CI, 0.87-1.25, and hazard ratio, 1.05, 95% CI, 0.93-1.19).
If convalescent plasma is offered as a therapeutic in a future viral pandemic, we recommend (1) transfusing only those patients who are negative for neutralizing antibodies, (2) transfusing very early during the disease course, (3) only using convalescent plasma with known levels of neutralizing antibodies, or (4) alternatively providing fractionated hyperimmune globulin.
2020年4月,梅奥诊所协助美国食品药品监督管理局制定了针对2019冠状病毒病(COVID-19)康复期血浆(CCP)的扩大使用方案。CCP在已发表文献中的有效性存在矛盾,因为一些回顾性研究显示其在降低死亡率和重症方面有益,而前瞻性随机对照试验则表明CCP并无益处。
探讨(1)2020年4月至2021年4月间南加州永久医疗集团对CCP的使用情况;(2)对2831例接受CCP输血的COVID-19患者与18475例未接受CCP的COVID-19患者进行回顾性多变量分析;(3)如何协调已发表的关于CCP疗效的矛盾数据;(4)关于在大型社区医院环境中未来使用康复期血浆的指导意见。
多变量分析对人口统计学特征、氧输送水平、重症监护病房停留时间、选定的实验室检查结果以及其他与同时进行的治疗相关的变量进行了控制。对2020年10月至2021年4月间输注的151个CCP单位的管路片段进行回顾性检测,以检测严重急性呼吸综合征冠状病毒2(SARS-CoV-2)抗刺突蛋白受体结合域IgG。多变量分析显示,CCP输血对30天和5个月时的死亡率没有影响(比值比,1.04;95%置信区间,0.87 - 1.25;风险比,1.05;95%置信区间,0.93 - 1.19)。
如果在未来的病毒性大流行中提供康复期血浆作为一种治疗方法,我们建议:(1)仅对中和抗体阴性的患者进行输血;(2)在病程早期进行输血;(3)仅使用已知中和抗体水平的康复期血浆;或者(4)提供分馏的高效免疫球蛋白。