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多剂量恢复期血浆用于COVID-19危重症患者的经验:一项1期早期描述性研究。

Experiences in the use of multiple doses of convalescent plasma in critically ill patients with COVID-19: An early phase 1 descriptive study.

作者信息

Aguilar Ricardo, López-Vergès Sandra, Quintana Anarellys, Morris Johanna, Lopez Lineth, Cooke Ana, Quiel Dimas, Buitron Natalie, Pérez Yaseikiry, Lobo Lesbia, Ballesteros Maura, Pitti Yaneth, Diaz Yamilka, Saenz Lisseth, Franco Danilo, Castillo Daniel, Valdespino Elimelec, Blanco Isabel, Romero Emilio, Villarreal Alcibiades, Cubilla-Batista Idalina

机构信息

Complejo Hospitalario Metropolitano Arnulfo Arias Madrid Caja de Seguro Social Panama Panama.

Hospital Punta Pacífica Pacífica Salud Panama Panama.

出版信息

Health Sci Rep. 2024 Mar 7;7(3):e1949. doi: 10.1002/hsr2.1949. eCollection 2024 Mar.

DOI:10.1002/hsr2.1949
PMID:38463033
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10920941/
Abstract

BACKGROUND

At the beginning of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, transfusion of coronavirus disease 2019 (COVID-19) convalescent plasma (CCP) emerged as a potential therapeutic strategy to help patients severely afflicted by COVID-19. The efficacy of CCP has been controversial as it depends on many variables pertaining to the plasma donor and the patient with COVID-19, for example, time of convalescence or symptoms onset. This feasibility and descriptive study aimed to assess the safety of multiple doses of CCP in mechanically ventilated, intubated patients with respiratory failure due to COVID-19.

METHODS

A cohort of 30 patients all experiencing severe respiratory failure and undergoing invasive mechanical ventilation in an intensive care unit, received up to five doses of 300-600 mL of CCP on alternate days (0, 2, 4, 6, and 8) until extubation, futility, or death.

RESULTS

Nineteen patients received five doses, seven received four, and four received two or three doses. At 28-day follow-up mark, 57% of patients recovered and were sent home, and the long-term mortality rate was 27%. Ten severe adverse events reported in the study were unrelated to CCP transfusion. Independent of the number of transfused doses, most patients had detectable levels of total and neutralizing antibodies in plasma.

CONCLUSION

This study suggests that transfusion of multiple doses of CCP is safe. This strategy may represent a viable option for future studies, given the potential benefit of CCP transfusions during the early stages of infection in unvaccinated populations and in settings where monoclonal antibodies or antivirals are contraindicated or unavailable.

摘要

背景

在严重急性呼吸综合征冠状病毒2(SARS-CoV-2)大流行初期,输注新型冠状病毒肺炎(COVID-19)康复期血浆(CCP)成为一种潜在的治疗策略,以帮助重症COVID-19患者。CCP的疗效一直存在争议,因为它取决于许多与血浆捐献者和COVID-19患者相关的变量,例如康复时间或症状出现时间。这项可行性和描述性研究旨在评估多剂量CCP在因COVID-19导致呼吸衰竭的机械通气、插管患者中的安全性。

方法

一组30名均患有严重呼吸衰竭并在重症监护病房接受有创机械通气的患者,每隔一天(第0、2、4、6和8天)接受多达五剂300 - 600毫升的CCP,直至拔管、治疗无效或死亡。

结果

19名患者接受了五剂,7名接受了四剂,4名接受了两剂或三剂。在28天的随访标记时,57%的患者康复并出院,长期死亡率为27%。该研究中报告的10起严重不良事件与CCP输注无关。无论输注剂量多少,大多数患者血浆中均可检测到总抗体和中和抗体水平。

结论

本研究表明,输注多剂量CCP是安全的。鉴于在未接种疫苗人群的感染早期以及在单克隆抗体或抗病毒药物禁忌或无法获得的情况下,CCP输注可能具有益处,该策略可能是未来研究的一个可行选择。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8518/10920941/f5450a4a82e7/HSR2-7-e1949-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8518/10920941/f24fb11c55a5/HSR2-7-e1949-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8518/10920941/f5450a4a82e7/HSR2-7-e1949-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8518/10920941/f24fb11c55a5/HSR2-7-e1949-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8518/10920941/f5450a4a82e7/HSR2-7-e1949-g001.jpg

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本文引用的文献

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Cochrane Database Syst Rev. 2023 May 10;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub6.
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Convalescent plasma and COVID-19: Time for a second-second look?恢复期血浆与 COVID-19:是否需要重新审视?
Transfus Med. 2023 Feb;33(1):16-20. doi: 10.1111/tme.12915. Epub 2022 Sep 11.
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Convalescent Plasma for Covid-19 - Making Sense of the Inconsistencies.用于治疗新冠病毒肺炎的康复期血浆——解读其中的不一致之处
N Engl J Med. 2022 May 5;386(18):1753-1754. doi: 10.1056/NEJMe2204332.
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Efficacy of convalescent plasma therapy in the patient with COVID-19: a randomised control trial (COPLA-II trial).恢复期血浆疗法治疗 COVID-19 患者的疗效:一项随机对照试验(COPLA-II 试验)。
BMJ Open. 2022 Apr 6;12(4):e055189. doi: 10.1136/bmjopen-2021-055189.
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Early Outpatient Treatment for Covid-19 with Convalescent Plasma.Covid-19 的早期门诊康復期血浆治疗。
N Engl J Med. 2022 May 5;386(18):1700-1711. doi: 10.1056/NEJMoa2119657. Epub 2022 Mar 30.
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COVID-19 Convalescent Plasma and Clinical Trials: Understanding Conflicting Outcomes.COVID-19 恢复期血浆与临床试验:解读相悖的结果
Clin Microbiol Rev. 2022 Sep 21;35(3):e0020021. doi: 10.1128/cmr.00200-21. Epub 2022 Mar 9.
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