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抗新型冠状病毒2感染的单克隆抗体:奥密克戎毒株激增前的一项真实研究结果

Monoclonal Antibodies against SARS-CoV-2 Infection: Results from a Real-Life Study before the Omicron Surge.

作者信息

Scotto Riccardo, Buonomo Antonio Riccardo, Zumbo Giulia, Di Fusco Antonio, Esposito Nunzia, Di Filippo Isabella, Nobile Mariano, Pinchera Biagio, Schiano Moriello Nicola, Villari Riccardo, Gentile Ivan

机构信息

Department of Clinical Medicine and Surgery, Section of Infectious Diseases, University "Federico II" of Naples, Via Sergio Pansini 5, 80128 Naples, Italy.

出版信息

Vaccines (Basel). 2022 Nov 10;10(11):1895. doi: 10.3390/vaccines10111895.

Abstract

Despite the lightning-fast advances in the management of SARS-CoV after 2 years of pandemic, COVID-19 continues to pose a challenge for fragile patients, who could benefit from early administration of monoclonal antibodies (mAbs) to reduce the risk of severe disease progression. We conducted a prospective study to evaluate the effectiveness of mAbs against SARS-CoV-2 among patients at risk for severe disease progression, namely elderly and those with comorbidities, before the omicron variant surge. Patients were treated with either casirivimab/imdevimab, sotrovimab, or bamlanivimab/etesevimab. The rates and risk factors for clinical worsening, hospitalization, ICU admission and death (unfavorable outcomes) were evaluated. A stratified analysis according to the presence of SARS-CoV-2 IgG was also performed. Among 185 included patients, we showed low rates of unfavorable outcomes (9.2%), which were more frequent in patients with chronic kidney disease (aOR: 10.44, 95% CI: 1.73−63.03; p < 0.05) and basal D-dimer serum concentrations > 600 ng/mL (aOR 21.74, 95% CI: 1.18−397.70; p < 0.05). Patients with negative SARS-CoV-2 serology at baseline showed higher C-reactive protein values compared with patients with positive serology (p < 0.05) and a trend toward a higher admission rate to SICU and ICU compared with patients with positive serology. Our results thus showed, in a real-life setting, the efficacy of mAbs against SARS-CoV-2 before an Omicron surge when the available mabs become not effective.

摘要

尽管在新冠大流行两年后,严重急性呼吸综合征冠状病毒(SARS-CoV)的管理取得了飞速进展,但新冠病毒疾病(COVID-19)仍然给脆弱患者带来挑战,这些患者可从早期使用单克隆抗体(mAbs)中获益,以降低严重疾病进展的风险。我们进行了一项前瞻性研究,以评估在奥密克戎变异株激增之前,mAbs对有严重疾病进展风险的患者(即老年人和合并症患者)对抗严重急性呼吸综合征冠状病毒2(SARS-CoV-2)的有效性。患者接受了卡西瑞单抗/伊德维单抗、索托维单抗或巴姆兰尼单抗/依替塞韦单抗治疗。评估了临床恶化、住院、重症监护病房(ICU)入院和死亡(不良结局)的发生率及风险因素。还根据SARS-CoV-2免疫球蛋白G(IgG)的存在情况进行了分层分析。在纳入的185例患者中,我们发现不良结局发生率较低(9.2%),在慢性肾病患者中更常见(调整后比值比:10.44,95%置信区间:1.73−63.03;p<0.05),且基础D-二聚体血清浓度>600 ng/mL时更常见(调整后比值比21.74,95%置信区间:1.18−397.70;p<0.05)。基线时SARS-CoV-2血清学检测阴性的患者与血清学检测阳性的患者相比,C反应蛋白值更高(p<0.05),且与血清学检测阳性的患者相比,入住外科重症监护病房(SICU)和ICU的比例有升高趋势。因此,我们的结果表明,在现实环境中,在奥密克戎激增之前,当可用的mAbs变得无效时,mAbs对SARS-CoV-2具有疗效。

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