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[使用病毒中和单克隆抗体卡西瑞单抗和依德维单抗联合治疗进展高危的轻至中度新冠肺炎患者:非干预性观察研究结果]

[Use of a combination of the virus-neutralizing monoclonal antibodies casirivimab and imdevimab for mild to moderate COVID-19 in patients at high risk of progression: Results of the non-interventional observational study].

作者信息

Lebedkina M S, Fomina D S, Mutovina Z Y, Mаrkina U A, Bogomolov P O, Chulanov V P, Lysenko M A, Alexeeva E I

机构信息

City Clinical Hospital №52, Moscow.

Sechenov First Moscow State Medical University (Sechenov University).

出版信息

Ter Arkh. 2023 Aug 17;95(6):494-499. doi: 10.26442/00403660.2023.06.202297.

DOI:10.26442/00403660.2023.06.202297
PMID:38158969
Abstract

AIM

To evaluate the efficacy and safety of a combination of virus-neutralizing monoclonal antibodies - MAB (casirivimab and imdevimab) in patients with mild to moderate COVID-19 with risk factors in real word settings.

MATERIALS AND METHODS

A non-interventional non-comparative observational study with primary prospective data collection included 108 patients with mild to moderate COVID-19 (mean age 61 years), who had risk factors for developing severe disease. All patients (=108) were treated with a combination of MAB casirivimab and imdevimab intravenous single infusion 1200 mg (600 mg of each component). The efficacy and safety of MAB were assessed at 7, 14, and 28 days after infusion.

RESULTS

Indications for hospitalization by day 7 from the moment of MAB administration were in 0.9% (=1), by day 14 - in 1.9% (=2), by day 28 - in 0.9% of patients; to stay in the intensive care units by the 7th day - in 4.6% (=5), by the 14th day - in 0.9% (=1), by the 28th day - in 0.9% (=1) patients. During 28 days of follow up, the need for mechanical ventilation and extracorporeal membrane oxygenation was registered in 2/108 (1.8%) patients. There were no deaths directly related to COVID-19 in the assessed cohort of patients. By the 28th day of the follow up, no adverse effects due to MAB therapy were registered.

CONCLUSION

An analysis of the results of a non-interventional observational study summarized in this article showed the high efficacy and safety of virus-neutralizing MAB combination (casirivimab and imdevimab) in patients with mild to moderate COVID-19 with of risk factors for severe COVID-19 in real word settings.

摘要

目的

在现实环境中评估病毒中和单克隆抗体组合(MAB,卡西瑞维单抗和依德维单抗)对伴有风险因素的轻至中度新冠肺炎患者的疗效和安全性。

材料与方法

一项采用前瞻性原始数据收集的非干预性非对照观察性研究纳入了108例轻至中度新冠肺炎患者(平均年龄61岁),这些患者具有发展为重症疾病的风险因素。所有108例患者均接受卡西瑞维单抗和依德维单抗静脉单次输注1200毫克(各组分600毫克)的联合治疗。在输注后7天、14天和28天评估MAB的疗效和安全性。

结果

从给予MAB起,第7天住院指征患者占0.9%(=1例),第14天为1.9%(=2例),第28天为0.9%;第7天入住重症监护病房的患者占4.6%(=5例),第14天为0.9%(=1例),第28天为0.9%(=1例)。在28天的随访期间,108例患者中有2例(1.8%)需要机械通气和体外膜肺氧合。在评估的患者队列中,没有直接与新冠肺炎相关的死亡病例。到随访第28天,未记录到MAB治疗引起的不良反应。

结论

本文总结的非干预性观察性研究结果分析表明,在现实环境中,病毒中和MAB组合(卡西瑞维单抗和依德维单抗)对伴有重症新冠肺炎风险因素的轻至中度新冠肺炎患者具有高疗效和安全性。

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