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对 COVID-19 住院患者使用阿奇霉素的观察性研究。

Observational study of azithromycin in hospitalized patients with COVID-19.

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

PLoS One. 2020 Sep 3;15(9):e0238681. doi: 10.1371/journal.pone.0238681. eCollection 2020.

Abstract

BACKGROUND

The rapid spread of the disease caused by the novel SARS-CoV-2 virus has led to the use of multiple therapeutic agents whose efficacy has not been previously demonstrated. The objective of this study was to analyze whether there is an association between the use of azithromycin and the evolution of the pulmonary disease or the time to discharge, in patients hospitalized with COVID-19.

METHODS

This was an observational study on a cohort of 418 patients admitted to three regional hospitals in Catalonia, Spain. As primary outcomes, we studied the evolution of SAFI ratio (oxygen saturation/fraction of inspired oxygen) in the first 48 hours of treatment and the time to discharge. The results were compared between patients treated and untreated with the study drug through subcohort analyses matched for multiple clinical and prognostic factors, as well as through analysis of non-matched subcohorts, using Cox multivariate models adjusted for prognostic factors.

RESULTS

There were 239 patients treated with azithromycin. Of these, 29 patients treated with azithromycin could be matched with an equivalent number of control patients. In the analysis of these matched subcohorts, SAFI at 48h had no significant changes associated to the use of azithromycin, though azithromycin treatment was associated with a longer time to discharge (10.0 days vs 6.7 days; log rank: p = 0.039). However, in the unmatched cohorts, the increased hospital stay associated to azithromycin use, was no significant after adjustment using Multivariate Cox regression models: hazard ratio 1.45 (IC95%: 0.88-2.41; p = 0.150). This study is limited by its small sample size and its observational nature; despite the strong pairing of the matched subcohorts and the adjustment of the Cox regression for multiple factors, the results may be affected by residual confusion.

CONCLUSIONS

We did not find a clinical benefit associated with the use of azithromycin, in terms of lung function 48 hours after treatment or length of hospital stay.

摘要

背景

新型 SARS-CoV-2 病毒引起的疾病迅速传播,导致使用了多种以前未证明疗效的治疗药物。本研究的目的是分析在因 COVID-19 住院的患者中,使用阿奇霉素是否与肺部疾病的演变或出院时间有关。

方法

这是一项对西班牙加泰罗尼亚地区的 3 家医院的 418 名患者进行的观察性研究。主要结局是研究治疗后前 48 小时 SAFI 比值(血氧饱和度/吸入氧分数)的变化和出院时间。通过亚组分析比较了治疗和未治疗研究药物的患者的结果,该亚组分析针对多个临床和预后因素进行了匹配,同时还通过 Cox 多变量模型对未匹配的亚组进行了调整,该模型针对预后因素进行了调整。

结果

有 239 名患者接受了阿奇霉素治疗。其中,29 名接受阿奇霉素治疗的患者可以与数量相当的对照组患者相匹配。在这些匹配的亚组分析中,使用阿奇霉素治疗后 48 小时的 SAFI 没有显著变化,但阿奇霉素治疗与出院时间延长有关(10.0 天与 6.7 天;对数秩检验:p = 0.039)。然而,在未匹配的队列中,调整多变量 Cox 回归模型后,阿奇霉素使用与住院时间延长无关:危险比 1.45(95%CI:0.88-2.41;p = 0.150)。本研究受到其小样本量和观察性性质的限制;尽管匹配亚组的配对非常强,并且 Cox 回归模型对多个因素进行了调整,但结果可能仍受到残余混杂因素的影响。

结论

我们没有发现使用阿奇霉素在治疗后 48 小时的肺功能或住院时间方面有临床获益。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b5c3/7470304/c77de22d8b67/pone.0238681.g001.jpg

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