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[Lancet在线发表]:标准治疗联合阿奇霉素与单纯标准治疗用于住院重症新冠病毒感染患者
2020年10月10日 时讯速递, 进展交流 暂无评论

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Azithromycin in addition to standard of care versus standard of care alone in the treatment of patients admitted to the hospital with severe COVID-19 in Brazil (COALITION II): a randomised clinical trial

Remo H M Furtado, Otavio Berwanger, Henrique A Fonseca, et al

Lancet Published:September 04, 2020 DOI:https://doi.org/10.1016/S0140-6736(20)31862-6

Summary 摘要

Background 背景

The efficacy and safety of azithromycin in the treatment of COVID-19 remain uncertain. We assessed whether adding azithromycin to standard of care, which included hydroxychloroquine, would improve clinical outcomes of patients admitted to the hospital with severe COVID-19.

阿奇霉素治疗新冠病毒感染(COVID-19)的疗效及安全性并不确定。我们评价联合阿奇霉素与标准治疗(包括羟氯喹)能否改善重症COVID-19住院患者的临床预后。

Methods 方法

We did an open-label, randomised clinical trial at 57 centres in Brazil. We enrolled patients admitted to hospital with suspected or confirmed COVID-19 and at least one additional severity criteria as follows: use of oxygen supplementation of more than 4 L/min flow; use of high-flow nasal cannula; use of non-invasive mechanical ventilation; or use of invasive mechanical ventilation. Patients were randomly assigned (1:1) to azithromycin (500 mg via oral, nasogastric, or intravenous administration once daily for 10 days) plus standard of care or to standard of care without macrolides. All patients received hydroxychloroquine (400 mg twice daily for 10 days) because that was part of standard of care treatment in Brazil for patients with severe COVID-19. The primary outcome, assessed by an independent adjudication committee masked to treatment allocation, was clinical status at day 15 after randomisation, assessed by a six-point ordinal scale, with levels ranging from 1 to 6 and higher scores indicating a worse condition (with odds ratio [OR] greater than 1·00 favouring the control group). The primary outcome was assessed in all patients in the intention-to-treat (ITT) population who had severe acute respiratory syndrome coronavirus 2 infection confirmed by molecular or serological testing before randomisation (ie, modified ITT [mITT] population). Safety was assessed in all patients according to which treatment they received, regardless of original group assignment. This trial was registered at ClinicalTrials.govNCT04321278.

我们在巴西57所医院进行了一项开放标签随机临床试验。我们入选疑似或确诊COVID-19且满足至少一项严重程度标准的患者,即氧疗超过4 L/min,使用高流量鼻导管氧疗、无创或有创通气。患者按照1:1的比例接受随机分组,分为阿奇霉素(500 mg口服,鼻胃管或静脉使用,每日一次,疗程10天) 及标准治疗,或单纯标准治疗(不使用大环内酯)。所有患者均使用羟氯喹(400 mg,每日两次,疗程10天),因为这是巴西对于重症COVID-19患者的标准治疗。主要预后指标为随机分组后15天的临床状态(6分顺序量表,分值1-6,分值越高情况越差),由不了解试验分组的独立判断委员会进行评价(比值比 [OR] > 1·00提示对照组更好)。对意向治疗(ITT)人群中随机分组前通过分子生物学或血清学检测确诊SARS-CoV-2感染患者 (即修订 ITT [mITT] 人群)进行主要预后指标评价。对于所有接受治疗的患者(无论初始分组情况如何)进行安全性分析。试验在ClinicalTrials.gov注册,注册号 NCT04321278

Findings 结果

447 patients were enrolled from March 28 to May 19, 2020. COVID-19 was confirmed in 397 patients who constituted the mITT population, of whom 214 were assigned to the azithromycin group and 183 to the control group. In the mITT population, the primary endpoint was not significantly different between the azithromycin and control groups (OR 1·36 [95% CI 0·94–1·97], p=0·11). Rates of adverse events, including clinically relevant ventricular arrhythmias, resuscitated cardiac arrest, acute kidney failure, and corrected QT interval prolongation, were not significantly different between groups.

2020年3月28日至5月19日间共纳入447名患者。397名患者确诊COVID-19,为mITT人群,其中214名患者分至阿奇霉素组,183名患者分至对照组。在mITT人群中,阿奇霉素组和对照组间主要预后终点没有统计学差异(OR 1·36 [95% CI 0·94–1·97], p=0·11)。两组间不良事件(包括有临床意义的室性心律失常,经过复苏的心跳骤停,急性肾功能衰竭,经过校正的QT间期延长)无显著差异。

Interpretation 结论

In patients with severe COVID-19, adding azithromycin to standard of care treatment (which included hydroxychloroquine) did not improve clinical outcomes. Our findings do not support the routine use of azithromycin in combination with hydroxychloroquine in patients with severe COVID-19.

对于重症COVID-19患者,联合阿奇霉素与标准治疗(包括羟氯喹)不能改善临床预后。我们的发现不支持常规联合应用阿奇霉素与羟氯喹治疗重症COVID-19患者。

Funding 资助

COALITION COVID-19 Brazil and EMS.

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