阿奇黴素聯合羥氯喹治療重症COVID-19患者不能改善預後
作者：
小柯機器人發布時間：2020/9/8 21:33:51
巴西以色列阿爾伯特·愛因斯坦醫院Otavio Berwanger團隊研究了阿奇黴素聯合標準方案治療巴西重症COVID-19患者的效果。2020年9月4日，《柳葉刀》雜誌發表了該成果。
阿奇黴素治療COVID-19的有效性和安全性尚未明確。
研究組在巴西的57個中心進行了一項開放標籤的隨機臨床試驗，2020年3月28日至5月19日，共招募了447例疑似或確診COVID-19且至少有一項附加嚴重程度標準的住院患者，即：補充氧流量大於4 L/min；使用高流量鼻腔插管；使用無創機械通氣；或使用有創機械通氣。將397例確診患者隨機分組，其中214例接受阿奇黴素聯合標準治療，183例僅接受標準治療，巴西對重症COVID-19的標準治療均包含羥氯喹治療。
在改良意向治療分析人群中，阿奇黴素組和對照組間患者的六點序貫量表評分無顯著差異。兩組間的不良事件發生率，包括臨床相關室性心律失常、心臟驟停復甦、急性腎衰竭和校正QT間期延長等，均無統計學差異。
總之，阿奇黴素聯合羥氯喹治療重症COVID-19患者無益於改善臨床結局。
附：英文原文
Title: 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
Author: Remo H M Furtado, Otavio Berwanger, Henrique A Fonseca, Thiago D Corrêa, Leonardo R Ferraz, Maura G Lapa, Fernando G Zampieri, Viviane C Veiga, Luciano C P Azevedo, Regis G Rosa, Renato D Lopes, Alvaro Avezum, Airton L O Manoel, Felipe M T Piza, Priscilla A Martins, Thiago C Lisboa, Adriano J Pereira, Guilherme B Olivato, Vicente C S Dantas, Eveline P Milan, Otavio C E Gebara, Roberto B Amazonas, Monalisa B Oliveira, Ronaldo V P Soares, Diogo D F Moia, Luciana P A Piano, Kleber Castilho, Roberta G R A P Momesso, Guilherme P P Schettino, Luiz Vicente Rizzo, Ary Serpa Neto, Flávia R Machado, Alexandre B Cavalcanti
Issue&Volume: 2020-09-04
Abstract:
Background
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.
Methods
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.gov, NCT04321278.
Findings
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.
Interpretation
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.
DOI: 10.1016/S0140-6736(20)31862-6
Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31862-6/fulltext