托昔单抗未能降低严重 COVID-19 患者的死亡率:随机对照临床试验的结果。

IF 1.2 4区 医学 Q4 ALLERGY
Mona Talaschian, Maryam Akhtari, Mahdi Mahmoudi, Shayan Mostafaei, Mohamadreza Jafary, Seyyed Mostafa Jalali, Kourosh Sadeghi, Keivan Gohari Moghadam, Hengameh Ansari Tadi, Ahmadreza Jamshidi
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引用次数: 0

摘要

2019 年严重冠状病毒病(COVID-19)与血液中白细胞介素(IL)-6 水平升高有关。因此,我们假设调节 IL-6 的水平或作用可以减轻气道炎症并改变 COVID-19 的病程。我们在伊朗对重症 COVID-19 住院患者进行了一项对照、随机、双盲临床试验。患者通过分块随机分配的方式随机接受标准护理(SOC)加 1 或 2 剂托珠单抗 8 毫克/千克或单用 SOC。终点以临床改善和出院为标准。我们从 2020 年 7 月 10 日至 12 月 10 日招募了 40 名患者(每组 20 人)。随机分组后,有1名SOC组患者和3名托珠单抗组患者拒绝参与,被排除在研究之外。托西珠单抗组(8 名女性和 9 名男性)参与者的平均年龄为(59.62±15.80)岁,SOC 组(9 名女性和 10 名男性)参与者的平均年龄为(63.52±12.83)岁。托西珠单抗组和 SOC 组的痊愈患者人数差异不大(分别为 12 [70.6%][70.6%] vs. 15 [78.9%])。两组的住院率也相似(Log-rank 检验,P=0.615;危险比,0.83;95% CI [0.39-1.78])。结果表明,托西珠单抗不能成为治疗 COVID-19 重症患者的有效药物,也不会显著改善临床预后。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Tocilizumab Failed to Reduce Mortality in Severe COVID-19 Patients: Results from a Randomized Controlled Clinical Trial.

The severe coronavirus disease 2019 (COVID-19) is associated with increased levels of blood interleukin (IL)-6. Therefore, it is hypothesized that modulating the levels or effects of IL-6  could diminish airway inflammation and alter the course of COVID-19. We conducted a controlled, randomized, double-blind clinical trial on hospitalized patients with severe COVID-19 in Iran. The patients were randomly distributed by block randomization to take either standard-of-care (SOC) plus 1 or 2 doses of tocilizumab 8 mg/kg or SOC alone. The endpoint was defined by clinical improvement and discharge. We enrolled 40 patients (20 patients in each group) from 10 July to 10 December 2020. After randomization, 1 patient in the SOC arm and 3 patients in the tocilizumab arm refused to participate and were eliminated from the study. The mean age of participants was 59.62±15.80 in the tocilizumab group (8 women and 9 men) and 63.52±12.83 years old in the SOC group (9 women and 10 men) groups. The number of patients who recovered did not differ significantly between the tocilizumab and SOC groups (12 [70.6%][70.6%] vs. 15 [78.9%]), respectively). Hospitalization rates were also similar between the groups (Log-rank test, p=0.615; hazard ratio, 0.83; 95% C‎‎I [0.‎39-1.78]). The results show that tocilizumab could not be a beneficial agent for treating severe cases of COVID-19 patients and would not significantly improve clinical outcomes.

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来源期刊
CiteScore
2.60
自引率
6.70%
发文量
64
审稿时长
>12 weeks
期刊介绍: The Iranian Journal of Allergy, Asthma and Immunology (IJAAI), an international peer-reviewed scientific and research journal, seeks to publish original papers, selected review articles, case-based reviews, and other articles of special interest related to the fields of asthma, allergy and immunology. The journal is an official publication of the Iranian Society of Asthma and Allergy (ISAA), which is supported by the Immunology, Asthma and Allergy Research Institute (IAARI) and published by Tehran University of Medical Sciences (TUMS). The journal seeks to provide its readers with the highest quality materials published through a process of careful peer reviews and editorial comments. All papers are published in English.
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