对美国食品药品监督管理局授权的COVID-19治疗方法的快速系统评价。
A Rapid Systematic Review of U.S. Food and Drug Administration-Authorized COVID-19 Treatments.
作者信息
Maglione Margaret A, Klausner Jeffrey D, Wirnkar Patricia K, Fallarme Ivan, Lak Rozhin, Sysawang Kimny, Fu Ning, Yagyu Sachi, Motala Aneesa, Tolentino Danica, Hempel Susanne
机构信息
Southern California Evidence Review Center, University of Southern California Keck School of Medicine, Los Angeles, California, USA.
出版信息
Open Forum Infect Dis. 2025 Apr 11;12(4):ofaf097. doi: 10.1093/ofid/ofaf097. eCollection 2025 Apr.
BACKGROUND
The coronavirus disease 2019 (COVID-19) pandemic era saw numerous treatments authorized for emergency use by the United States (US) Food and Drug Administration (FDA). The purpose of the review was to determine if convalescent plasma, antivirals, or monoclonal antibodies are associated with serious adverse events (SAEs) and, if so, which specific populations are at risk.
METHODS
PubMed, ClinicalTrials.gov, and the FDA submission database were searched through December 2023, and the Infectious Diseases Society of America guidelines, international COVID Network Meta-analysis database, and systematic reviews were reference mined to identify controlled studies with at least 1 US site. Reviewers abstracted study characteristics, number of patients experiencing each type of SAE, and methods of adverse event collection and reporting.
RESULTS
Fifty-four studies met inclusion criteria, including 31 randomized controlled trials. We found insufficient evidence of association of any SAE with antivirals and spike protein receptor-binding antibodies. In patients hospitalized with COVID-19, the monoclonal antibody tocilizumab, an interleukin 6 inhibitor, may be associated with elevated risk of neutropenia (moderate certainty) and infection (limited certainty). Convalescent plasma may be associated with thrombotic events (limited certainty) as well as bleeding events and infection in patients with hematologic cancers (moderate certainty). Inclusion of studies without a US site could potentially change the findings.
CONCLUSIONS
Severe COVID-19 infection may have serious consequences, especially in hospitalized patients with comorbidities. These consequences may be confused with toxicities of the interventions. Based on our analysis, approved treatments for COVID-19 should be prescribed as clinically indicated, although continued vigilance is warranted to identify rare and potentially significant toxicities that may arise in clinical practice.
CLINICAL TRIALS REGISTRATION
PROSPERO (CRD42023467821).
背景
在2019冠状病毒病（COVID-19）大流行时期，美国食品药品监督管理局（FDA）批准了多种治疗方法用于紧急使用。本综述的目的是确定康复期血浆、抗病毒药物或单克隆抗体是否与严重不良事件（SAEs）相关，如果是，哪些特定人群有风险。
方法
检索截至2023年12月的PubMed、ClinicalTrials.gov和FDA提交数据库，并参考美国传染病学会指南、国际COVID网络荟萃分析数据库和系统评价，以识别至少有1个美国研究地点的对照研究。评审人员提取了研究特征、每种SAE类型的患者数量以及不良事件收集和报告方法。
结果
54项研究符合纳入标准，包括31项随机对照试验。我们发现没有足够证据表明任何SAE与抗病毒药物和刺突蛋白受体结合抗体有关。在COVID-19住院患者中，白细胞介素6抑制剂单克隆抗体托珠单抗可能与中性粒细胞减少风险升高（中等确定性）和感染风险升高（有限确定性）有关。康复期血浆可能与血栓形成事件（有限确定性）以及血液系统癌症患者的出血事件和感染有关（中等确定性）。纳入没有美国研究地点的研究可能会改变研究结果。
结论
严重的COVID-19感染可能会产生严重后果，尤其是在患有合并症的住院患者中。这些后果可能与干预措施的毒性相混淆。根据我们的分析，COVID-19的批准治疗应根据临床指征开具，尽管仍需持续警惕以识别临床实践中可能出现的罕见且潜在重大的毒性反应。
临床试验注册
PROSPERO（CRD42023467821）
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