托珠单抗在 COVID-19 中的应用的原理和证据：系统评价。
Rationale and evidence on the use of tocilizumab in COVID-19: a systematic review.
机构信息
Department of Surgical, Oncological and Oral Science (Di.Chir.On.S.), University of Palermo. Department of Anesthesia Intensive Care and Emergency, Policlinico Paolo Giaccone, Palermo, Italy.
Department of Anesthesiology and Intensive Care, Humanitas Clinical and Research Center - IRCCS, Milan, Italy; Department of Biomedical Science, Humanitas University, Milan, Italy.
出版信息
Pulmonology. 2021 Jan-Feb;27(1):52-66. doi: 10.1016/j.pulmoe.2020.07.003. Epub 2020 Jul 20.
BACKGROUND
Tocilizumab is an IL-6 receptor-blocking agent proposed for the treatment of severe COVID-19. The aim of this systematic review was to describe the rationale for the use of tocilizumab for the treatment of COVID-19 and to summarize the available evidence regarding its efficacy and safety.
METHODS
MEDLINE, PubMed, EMBASE, pre-print repositories (bioRxiv and medRxiv) and two trial Registries were searched for studies on the use of tocilizumab in COVID-19 or SARS-CoV-2 infection, viral pneumonia, and/or sepsis until 20th June 2020.
RESULTS
We identified 3 indirect pre-clinical studies and 28 clinical studies including 5776 patients with COVID-19 (13 with a comparison group, 15 single-arm). To date, no randomized trials have been published. We retrieved no studies at low risk of bias. Forty-five ongoing studies were retrieved from trial registries.
CONCLUSIONS
There is insufficient evidence regarding the clinical efficacy and safety of tocilizumab in patients with COVID-19. Its use should be considered experimental, requiring ethical approval and clinical trial oversight.
背景
托珠单抗是一种白细胞介素-6（IL-6）受体阻断剂，被提议用于治疗严重的 COVID-19。本系统评价旨在描述使用托珠单抗治疗 COVID-19 的原理，并总结其疗效和安全性的现有证据。
方法
检索 MEDLINE、PubMed、EMBASE、预印本存储库（bioRxiv 和 medRxiv）和两个试验登记处，查找关于托珠单抗治疗 COVID-19 或 SARS-CoV-2 感染、病毒性肺炎和/或脓毒症的研究，截至 2020 年 6 月 20 日。
结果
我们确定了 3 项间接临床前研究和 28 项临床研究，包括 5776 例 COVID-19 患者（13 项有对照组，15 项为单臂）。迄今为止，尚未发表随机对照试验。我们没有检索到低偏倚风险的研究。从试验登记处检索到 45 项正在进行的研究。
结论
目前关于 COVID-19 患者使用托珠单抗的临床疗效和安全性的证据不足。其使用应被视为实验性的，需要获得伦理批准和临床试验监督。
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