早期高滴度恢复期血浆治疗可预防老年人严重Covid-19感染
2021-01-08   阅读:280   来源:新英格兰医学杂志

阿根廷INFANT基金会Fernando P. Polack团队研究了早期高滴度恢复期血浆治疗预防老年人严重Covid-19感染的疗效。2021年1月6日,该研究发表在《新英格兰医学杂志》上。

阻断早期Covid-19进展的治疗方法仍未明确。其中,对住院患者给予恢复期血浆治疗一直不成功,或许是因为未在发病早期就给予抗体治疗。

研究组进行了一项随机、双盲、安慰剂对照试验,招募出现轻度Covid-19症状72小时内的老年患者,随机接受抗SARS-CoV-2高IgG滴度的恢复期血浆或安慰剂进行治疗。主要终点是严重呼吸系统疾病,定义为呼吸频率为每分钟30次及以上,或呼吸环境空气时血氧饱和度低于93%,或两者都有。

共有160名患者接受了随机分组。在意向治疗人群中,接受恢复期血浆治疗的80例患者中有13例(16%)发生了严重呼吸系统疾病,接受安慰剂的80例患者中有25例(31%),组间差异显著,相对风险降低了48%。校正后的意向治疗分析排除了6名在恢复期血浆或安慰剂输注之前发生主要终点事件的患者,显示出更优的疗效,相对风险为0.40。未观察到引发不良事件。

研究结果表明,对轻度SARS-CoV-2感染的老年人早期给予高滴度的恢复期血浆可延缓Covid-19的疾病进展。

附:英文原文

Title: Early High-Titer Plasma Therapy to Prevent Severe Covid-19 in Older Adults

Author: Romina Libster, M.D.,, Gonzalo Pérez Marc, M.D.,, Diego Wappner, M.D.,, Silvina Coviello, M.S.,, Alejandra Bianchi,, Virginia Braem,, Ignacio Esteban, M.D.,, Mauricio T. Caballero, M.D.,, Cristian Wood, M.D.,, Mabel Berrueta, M.D.,, Aníbal Rondan, M.D.,, Gabriela Lescano, M.D.,, Pablo Cruz, M.D.,, Yvonne Ritou, M.D.,, Valeria Fernández Via, M.D.,, Damián álvarez Paggi, Ph.D.,, Sebastián Esperante, Ph.D.,, Adrián Ferreti,, Gastón Ofman, M.D.,, álvaro Ciganda, B.I.T.,, Rocío Rodriguez,, Jorge Lantos, M.D.,, Ricardo Valentini, M.D.,, Nicolás Itcovici, M.D.,, Alejandra Hintze, M.D.,, M. Laura Oyarvide, M.D.,, Candela Etchegaray, M.D.,, Alejandra Neira, M.D.,, Ivonne Name, M.D.,, Julieta Alfonso, M.D.,, Rocío López Castelo, M.D.,, Gisela Caruso, M.D.,, Sofía Rapelius, M.S.,, Fernando Alvez, M.D.,, Federico Etchenique, M.D.,, Federico Dimase, M.D.,, Darío Alvarez, M.S.,, Sofía S. Aranda, M.D.,, Clara Sánchez Yanotti,, Julián De Luca,, Sofía Jares Baglivo,, Sofía Laudanno,, Florencia Nowogrodzki,, Ramiro Larrea, M.D.,, María Silveyra, M.D.,, Gabriel Leberzstein, M.D.,, Alejandra Debonis, M.D.,, Juan Molinos, M.D.,, Miguel González, M.D.,, Eduardo Perez, M.D.,, Nicolás Kreplak, M.D.,, Susana Pastor Argüello, M.D.,, Luz Gibbons, Ph.D.,, Fernando Althabe, M.D.,, Eduardo Bergel, Ph.D.,, and Fernando P. Polack, M.D.

Issue&Volume: 2021-01-06

Abstract:

BACKGROUND

Therapies to interrupt the progression of early coronavirus disease 2019 (Covid-19) remain elusive. Among them, convalescent plasma administered to hospitalized patients has been unsuccessful, perhaps because antibodies should be administered earlier in the course of illness.

METHODS

We conducted a randomized, double-blind, placebo-controlled trial of convalescent plasma with high IgG titers against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in older adult patients within 72 hours after the onset of mild Covid-19 symptoms. The primary end point was severe respiratory disease, defined as a respiratory rate of 30 breaths per minute or more, an oxygen saturation of less than 93% while the patient was breathing ambient air, or both. The trial was stopped early at 76% of its projected sample size because cases of Covid-19 in the trial region decreased considerably and steady enrollment of trial patients became virtually impossible.

RESULTS

A total of 160 patients underwent randomization. In the intention-to-treat population, severe respiratory disease developed in 13 of 80 patients (16%) who received convalescent plasma and 25 of 80 patients (31%) who received placebo (relative risk, 0.52; 95% confidence interval [CI], 0.29 to 0.94; P=0.03), with a relative risk reduction of 48%. A modified intention-to-treat analysis that excluded 6 patients who had a primary end-point event before infusion of convalescent plasma or placebo showed a larger effect size (relative risk, 0.40; 95% CI, 0.20 to 0.81). No solicited adverse events were observed.

CONCLUSIONS

Early administration of high-titer convalescent plasma against SARS-CoV-2 to mildly ill infected older adults reduced the progression of Covid-19.

DOI: 10.1056/NEJMoa2033700

 

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