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一项关于使用康复期血浆治疗重症新型冠状病毒肺炎的II期研究——倾向评分匹配对照分析

A Phase II Study on the Use of Convalescent Plasma for the Treatment of Severe COVID-19- A Propensity Score-Matched Control Analysis.

作者信息

Pappa Vasiliki, Bouchla Anthi, Terpos Evangelos, Thomopoulos Thomas P, Rosati Margherita, Stellas Dimitris, Antoniadou Anastasia, Mentis Andreas, Papageorgiou Sotirios G, Politou Marianna, Kotanidou Anastasia, Kalomenidis Ioannis, Poulakou Garyfalia, Jahaj Edison, Korompoki Eleni, Grigoropoulou Sotiria, Hu Xintao, Bear Jenifer, Karaliota Sevasti, Burns Robert, Pagoni Maria, Trontzas Ioannis, Grouzi Elisavet, Labropoulou Stavroula, Stamoulis Kostantinos, Bamias Aristotelis, Tsiodras Sotirios, Felber Barbara K, Pavlakis George N, Dimopoulos Meletios- Athanasios

机构信息

Hematology Unit, Second Propaedeutic Department of Internal Medicine and Research Institute, School of Medicine National and Kapodistrian University of Athens, University General Hospital "Attikon", 18120 Athens, Greece.

Department of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, 11528 Athens, Greece.

出版信息

Microorganisms. 2021 Apr 11;9(4):806. doi: 10.3390/microorganisms9040806.

Abstract

COVID-19 is a global pandemic associated with increased morbidity and mortality. Convalescent plasma (CP) infusion is a strategy of potential therapeutic benefit. We conducted a multicenter phase II study to evaluate the efficacy and safety of CP in patients with COVID-19, grade 4 or higher. To evaluate the efficacy of CP, a matched propensity score analysis was used comparing the intervention ( = 59) to a control group ( = 59). Sixty patients received CP within a median time of 7 days from symptom onset. During a median follow-up of 28.5 days, 56/60 patients fully recovered and 1 patient remained in the ICU. The death rate in the CP group was 3.4% vs. 13.6% in the control group. By multivariate analysis, CP recipients demonstrated a significantly reduced risk of death [HR: 0.04 (95% CI: 0.004-0.36), : 0.005], significantly better overall survival by Kaplan-Meir analysis ( < 0.001), and increased probability of extubation [OR: 30.3 (95% CI: 2.64-348.9), : 0.006]. Higher levels of antibodies in the CP were independently associated with significantly reduced risk of death. CP infusion was safe with only one grade 3 adverse event (AE), which easily resolved. CP used early may be a safe and effective treatment for patients with severe COVID-19 (trial number NCT04408209).

摘要

新型冠状病毒肺炎(COVID-19)是一种与发病率和死亡率增加相关的全球大流行病。输注康复期血浆(CP)是一种具有潜在治疗益处的策略。我们进行了一项多中心II期研究,以评估CP对4级及以上COVID-19患者的疗效和安全性。为了评估CP的疗效,采用匹配倾向评分分析,将干预组(n = 59)与对照组(n = 59)进行比较。60例患者在症状出现后的中位时间7天内接受了CP输注。在中位随访28.5天期间,60例患者中有56例完全康复,1例患者仍在重症监护病房(ICU)。CP组的死亡率为3.4%,而对照组为13.6%。通过多变量分析,接受CP输注的患者死亡风险显著降低[风险比(HR):0.04(95%置信区间:0.004 - 0.36),P = 0.005],根据Kaplan-Meir分析总体生存率显著更好(P < 0.001),拔管概率增加[比值比(OR):30.3(95%置信区间:2.64 - 348.9),P = 0.006]。CP中较高水平的抗体与死亡风险显著降低独立相关。CP输注是安全的,仅发生1例3级不良事件(AE),且易于缓解。早期使用CP可能是治疗重症COVID-19患者的一种安全有效的方法(试验编号NCT04408209)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4e70/8069820/56627a3d9abc/microorganisms-09-00806-g001.jpg

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