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托珠单抗治疗新型冠状病毒肺炎患者疗效的匹配队列研究

Matched cohort study on the efficacy of tocilizumab in patients with COVID-19.

作者信息

Rodríguez-Molinero Alejandro, Pérez-López Carlos, Gálvez-Barrón César, Miñarro Antonio, Macho Oscar, López Gabriela F, Robles Maria Teresa, Dapena Maria Dolores, Martínez Sergi, Rodríguez Ezequiel, Pérez Isabel Collado

机构信息

Research Area, Consorci Sanitari de l'Alt Penedès i Garraf (CSAPG), Sant Pere de Ribes, Barcelona, Spain.

Technical Research Center for Dependency Care and Autonomous Living (CETpD), Universitat Politècnica de Catalunya, Vilanova i la Geltru, Spain.

出版信息

One Health. 2021 Jun;12:100214. doi: 10.1016/j.onehlt.2021.100214. Epub 2021 Jan 5.

Abstract

BACKGROUND

Tocilizumab has been proposed as a treatment for the new disease COVID-19, however, there is not enough scientific evidence to support this treatment. The objective of this study is to analyze whether the use of tocilizumab is associated with respiratory improvement and a shorter time to discharge in patients with COVID-19 and lung involvement.

METHODS

Observational study on a cohort of 418 patients, admitted to three county hospitals in Catalonia (Spain). Patients admitted consecutively were included and followed until discharge or up to 30 days of admission. A sub-cohort of patients treated with tocilizumab and a sub-cohort of control patients were identified, matched by a large number of risk factors and clinical variables. Sub-cohorts were also matched by the number of other treatments for COVID-19 that patients received. Increment in SAFI (inspired oxygen fraction / saturation) 48 h after the start of treatment, and time to discharge, were the primary outcomes. Mortality, which was a secondary outcome, was analyzed in the total cohort, by using logistic regression models, adjusted by confounders.

RESULTS

There were 96 patients treated with tocilizumab. Of them, 22 patients could be matched with an equivalent number of control patients. The increment in SAFI from baseline to 48 h of treatment, was not significantly different between groups (tocilizumab: -0.04; control: 0.09;  = 0.636). Also, no difference in time to discharge was found between the two sub-cohorts (logrank test:  = 0.472). The logistic regression models, did not show an effect of tocilizumab on mortality (OR 0.99;  = 0.990).

CONCLUSIONS

We did not find a clinical benefit associated with the use tocilizumab, in terms of respiratory function at 48 h of treatment, or time to discharge.

摘要

背景

托珠单抗已被提议用于治疗新型疾病 COVID-19,然而,尚无足够的科学证据支持这种治疗方法。本研究的目的是分析在 COVID-19 合并肺部受累的患者中,使用托珠单抗是否与呼吸功能改善及缩短出院时间相关。

方法

对西班牙加泰罗尼亚地区三家县级医院收治的 418 例患者进行观察性研究。连续收治的患者被纳入研究并随访至出院或入院 30 天。确定了接受托珠单抗治疗的患者亚组和对照患者亚组,通过大量危险因素和临床变量进行匹配。亚组还根据患者接受的其他 COVID-19 治疗的数量进行匹配。治疗开始后 48 小时的 SAFI(吸入氧分数/饱和度)增量和出院时间是主要结局。使用逻辑回归模型在总队列中分析死亡率这一次要结局,并对混杂因素进行调整。

结果

有 96 例患者接受了托珠单抗治疗。其中,22 例患者可与同等数量的对照患者匹配。两组之间从基线到治疗 48 小时的 SAFI 增量无显著差异(托珠单抗组:-0.04;对照组:0.09;P = 0.636)。此外,两个亚组之间的出院时间也没有差异(对数秩检验:P = 0.472)。逻辑回归模型未显示托珠单抗对死亡率有影响(OR 0.99;P = 0.990)。

结论

在治疗 48 小时的呼吸功能或出院时间方面,我们未发现使用托珠单抗有临床益处。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/739f/7817491/d36a7067d17f/gr1.jpg

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