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托珠单抗治疗机械通气 COVID-19 患者的疗效(T-MVC-19 研究):一项多中心真实世界证据。

Tocilizumab effectiveness in mechanically ventilated COVID-19 patients (T-MVC-19 Study): a multicenter real-world evidence.

机构信息

Department of Clinical Pharmacy, King Faisal Specialist Hospital and Research Center, Jeddah, Saudi Arabia; King Saud Medical City, Riyadh, Saudi Arabia.

Department of Clinical Pharmacy, Prince Sattam Bin Abdulaziz University, Alkharj, Saudi Arabia; Center for Health Outcomes and PharmacoEconomic Research, University of Arizona, Tucson, AZ, USA.

出版信息

Expert Rev Anti Infect Ther. 2022 Jul;20(7):1037-1047. doi: 10.1080/14787210.2022.2046462. Epub 2022 Mar 7.

Abstract

BACKGROUND

This study aimed to evaluate the effectiveness of tocilizumab in mechanically ventilated patients with coronavirus disease 2019 (COVID-19).

RESEARCH DESIGN AND METHODS

This retrospective multicenter study included adults (≥18 years) diagnosed with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by real-time polymerase chain reaction (RT-PCR) from nasopharyngeal swab, and requiring invasive mechanical ventilation during admission. Survival analyses with inverse propensity score treatment weighting (IPTW) and propensity score matching (PSM) were conducted. To account for immortal bias, we used Cox proportional modeling with time-dependent covariance. Competing risk analysis was performed for the extubation endpoint.

RESULTS

A total of 556 (tocilizumab = 193, control = 363) patients were included. Males constituted the majority of the participants (69.2% in tocilizumab arm,74.1% in control arm). Tocilizumab was not associated with a reduction in mortality with hazard ratio [(HR) = 0.82,95% confidence interval (95%CI): 0.62-1.10] in the Inverse propensity score weighting (IPTW) analysis and (HR = 0.86,95% CI: 0.64-1.16) in the PSM analysis. However, tocilizumab was associated with an increased rate of extubation (33.6%) compared to the control arm (11.9%); subdistributional hazards (SHR) = 3.1, 95% CI: 1.86-5.16).

CONCLUSIONS

Although tocilizumab was not found to be effective in reducing mortality, extubation rate while on mechanical ventilation was higher among tocilizumab treated group.

摘要

背景

本研究旨在评估托珠单抗在 COVID-19 机械通气患者中的疗效。

研究设计和方法

本回顾性多中心研究纳入了通过鼻咽拭子实时聚合酶链反应(RT-PCR)确诊为严重急性呼吸综合征冠状病毒 2(SARS-CoV-2)的成年人(≥18 岁),且在住院期间需要有创机械通气。采用逆倾向评分治疗加权(IPTW)和倾向评分匹配(PSM)进行生存分析。为了考虑到不朽偏差,我们使用了带有时间依赖性协方差的 Cox 比例模型。对拔管终点进行竞争风险分析。

结果

共纳入 556 例患者(托珠单抗组=193 例,对照组=363 例)。男性在研究人群中占大多数(托珠单抗组 69.2%,对照组 74.1%)。在逆倾向评分加权(IPTW)分析中,托珠单抗与死亡率降低无关,风险比(HR)为 0.82(95%置信区间(95%CI):0.62-1.10),在倾向评分匹配(PSM)分析中,HR 为 0.86(95%CI:0.64-1.16)。然而,与对照组(11.9%)相比,托珠单抗组的拔管率(33.6%)更高;亚分布风险比(SHR)为 3.1,95%CI:1.86-5.16。

结论

尽管托珠单抗并未被发现能降低死亡率,但在接受机械通气治疗的患者中,托珠单抗组的拔管率更高。

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