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一项关于奥密克戎时代实体器官移植受者新冠病毒病早期治疗的单中心回顾性研究:结果与严重急性呼吸综合征冠状病毒2病毒动力学

A Single-Center Retrospective Study on Early Treatment for COVID-19 in Solid Organ Transplant Recipients During the Omicron Era: Outcomes and SARS-CoV-2 Viral Kinetics.

作者信息

Milozzi Eugenia, Biliotti Elisa, Caioli Alessandro, Mazzotta Valentina, Loiacono Laura, Meschi Silvia, Rianda Alessia, Antinori Andrea, Maggi Fabrizio, D'Offizi Gianpiero

机构信息

Infectious Diseases and Hepatology Unit, National Institute for Infectious Diseases Lazzaro Spallanzani-IRCCS, 00149 Rome, Italy.

Department of Epidemiology, National Institute for Infectious Diseases Lazzaro Spallanzani-IRCCS, 00149 Rome, Italy.

出版信息

Microorganisms. 2025 Aug 11;13(8):1872. doi: 10.3390/microorganisms13081872.

Abstract

Solid organ transplant recipients (SOTRs) are at high risk of severe coronavirus disease 2019 (COVID-19), therefore early treatment of mild infections is crucial to prevent increased morbidity and mortality. The effectiveness of early treatment in SOTRs has yet to be fully characterized due to the emergence of new SARS-CoV-2 variants and to COVID-19 vaccination implementation. The aim of this single-center retrospective study is to evaluate the outcomes, safety and impact on SARS-CoV-2 viral load kinetics of COVID-19 early treatment in SOTRs. The study includes 80 SOTRs with a laboratory-confirmed diagnosis of symptomatic SARS-CoV-2 infection enrolled between January and October 2022 and treated with either monoclonal antibodies or antivirals. All patients received COVID-19 vaccination and 68.8% of them showed detectable levels of anti-spike (S) antibodies. The occurrence of clinical events (hospitalization, intensive care unit admission, or death) was assessed within 30 days after treatment initiation. The quantification of SARS-CoV-2 viral load were performed at baseline and at day-7. The rate of hospitalization was 2.5% [0.3-9%] and no deaths occurred. All patients completed treatment with no serious adverse events. Median viral load decrease was 0.48 [0.26-0.69] log cycle threshold (ct) values, with no significant differences between SOTRs treated with monoclonal antibodies and those treated with antivirals. Viral load decrease was significantly associated with positive anti-s serology at baseline (β = 0.196, = 0.01), number of days between symptom onset and treatment (β = 0.05, = 0.03) and the number of comorbidities (β = -0.05, = 0.03). We provide evidence of real-world effectiveness of early therapy in SOTRs infected with SARS-CoV-2 and demonstrate the relevant role of humoral response to vaccination in enhancing early viral load decay during treatment.

摘要

实体器官移植受者(SOTR)感染2019冠状病毒病(COVID-19)后发生重症的风险很高,因此对轻度感染进行早期治疗对于预防发病率和死亡率上升至关重要。由于新型严重急性呼吸综合征冠状病毒2(SARS-CoV-2)变体的出现以及COVID-19疫苗的接种,SOTR早期治疗的有效性尚未得到充分阐明。本单中心回顾性研究的目的是评估SOTR中COVID-19早期治疗的疗效、安全性以及对SARS-CoV-2病毒载量动力学的影响。该研究纳入了80例在2022年1月至10月期间实验室确诊为有症状SARS-CoV-2感染并接受单克隆抗体或抗病毒药物治疗的SOTR。所有患者均接种了COVID-19疫苗,其中68.8%的患者抗刺突(S)抗体水平可检测到。在开始治疗后30天内评估临床事件(住院、重症监护病房入院或死亡)的发生情况。在基线和第7天对SARS-CoV-2病毒载量进行定量分析。住院率为2.5%[0.3 - 9%],无死亡病例。所有患者均完成治疗,未发生严重不良事件。病毒载量中位数下降0.48[0.26 - 0.69]对数循环阈值(ct)值,接受单克隆抗体治疗的SOTR与接受抗病毒药物治疗的SOTR之间无显著差异。病毒载量下降与基线时抗S血清学阳性(β = 0.196,P = 0.01)、症状出现至治疗的天数(β = 0.05,P = 0.03)以及合并症数量(β = -0.05,P = 0.03)显著相关。我们提供了SARS-CoV-2感染的SOTR早期治疗在现实世界中的有效性证据,并证明了体液免疫反应对疫苗接种在增强治疗期间早期病毒载量衰减方面的重要作用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e242/12388748/5f94daeb89b6/microorganisms-13-01872-g001.jpg

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