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巴瑞替尼与托珠单抗治疗重症 COVID-19 的结局和不良反应。

Outcomes and Adverse Effects of Baricitinib Versus Tocilizumab in the Management of Severe COVID-19.

机构信息

Department of Pharmacy, Wellstar Kennestone Hospital, Marietta, GA.

Department of Infectious Disease, Wellstar Kennestone Hospital, Marietta, GA.

出版信息

Crit Care Med. 2023 Mar 1;51(3):337-346. doi: 10.1097/CCM.0000000000005756. Epub 2022 Dec 19.

Abstract

OBJECTIVES

The National Institutes of Health and Infectious Diseases Society of America guidelines recommend tocilizumab or baricitinib in the management of severe COVID-19. Despite clinical trials on the individual agents, there are no large-scale studies comparing the two agents to guide the selection of one versus the other. The purpose of this study was to compare the outcomes and adverse effects of baricitinib versus tocilizumab in the management of severe COVID-19.

DESIGN

Retrospective, observational cohort study.

SETTING

Eleven acute care hospitals in a large health system in Georgia.

PATIENTS

Adult patients with severe COVID-19 who received at least one dose of either baricitinib or tocilizumab between June 2021 and October 2021.

INTERVENTIONS

None.

MEASUREMENTS AND MAIN RESULTS

The primary outcome was in-hospital mortality. The key secondary outcome was occurrence rate of adverse effects. A total of 956 patients were identified. The median age was 57 years, and 53% were of male sex. The median body mass index was 33.5, and more than 94% of the population was unvaccinated. Propensity score matching by baseline characteristics resulted in a total of 582 patients, 291 in each group. There was no difference in mortality between the two groups; however, the occurrence rate of adverse effects was significantly higher in the tocilizumab group compared with baricitinib: secondary infections (32% vs 22%; p < 0.01); thrombotic events (24% vs 16%; p < 0.01); and acute liver injury (8% vs 3%; p < 0.01).

CONCLUSIONS

Our propensity score-matched, retrospective, observational study in patients hospitalized with severe COVID-19 showed no difference in mortality but significantly fewer adverse effects with baricitinib compared with tocilizumab. Our data suggest that baricitinib may be a better choice when treating patients with severe COVID-19, but additional prospective, randomized trials are needed to help clinicians choose the most optimal drug.

摘要

目的

美国国立卫生研究院和传染病学会的指南建议在严重 COVID-19 的治疗中使用托珠单抗或巴瑞替尼。尽管对这两种药物进行了临床试验,但没有大规模的研究比较这两种药物,以指导选择其中一种。本研究旨在比较巴瑞替尼与托珠单抗在严重 COVID-19 治疗中的疗效和不良反应。

设计

回顾性观察队列研究。

地点

佐治亚州一个大型医疗系统的 11 家急性护理医院。

患者

2021 年 6 月至 2021 年 10 月期间至少接受过一次巴瑞替尼或托珠单抗治疗的严重 COVID-19 成年患者。

干预措施

无。

测量和主要结果

主要结局是住院死亡率。关键次要结局是不良反应发生率。共确定了 956 名患者。中位年龄为 57 岁,53%为男性。中位体重指数为 33.5,超过 94%的人群未接种疫苗。通过基线特征进行倾向评分匹配后,共纳入 582 名患者,每组 291 名。两组间死亡率无差异;然而,托珠单抗组的不良反应发生率明显高于巴瑞替尼组:继发感染(32%比 22%;p<0.01);血栓事件(24%比 16%;p<0.01);和急性肝损伤(8%比 3%;p<0.01)。

结论

我们对因严重 COVID-19 住院的患者进行的倾向评分匹配、回顾性、观察性研究表明,死亡率无差异,但与托珠单抗相比,巴瑞替尼的不良反应明显更少。我们的数据表明,在治疗严重 COVID-19 患者时,巴瑞替尼可能是一个更好的选择,但需要更多的前瞻性、随机试验来帮助临床医生选择最理想的药物。

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