Luigi Sacco Department of Biomedical and Clinical Sciences, University of Milan, Italy; Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Milan, Italy.
Department of Infectious Diseases, ASST Fatebenefratelli-Sacco, Milan, Italy.
Pharmacol Res. 2020 Aug;158:104899. doi: 10.1016/j.phrs.2020.104899. Epub 2020 May 11.
SARS-CoV-2 is causing an increasing number of deaths worldwide because no effective treatment is currently available. Remdesivir has shown in vitro activity against coronaviruses and is a possible antiviral treatment for SARS-CoV-2 infection. This prospective (compassionate), open-label study of remdesivir, which was conducted at Luigi Sacco Hospital, Milan, Italy, between February 23 and March 20, 2020, involved patients with SARS-CoV-2 pneumonia aged ≥18 years undergoing mechanical ventilation or with an oxygen saturation level of ≤94 % in air or a National Early Warning Score 2 of ≥4. The primary outcome was the change in clinical status based on a 7-category ordinal scale (1 = not hospitalised, resuming normal daily activities; 7 = deceased). The 35 patients enrolled from February 23 to March 20, 2020, included 18 in intensive care unit (ICU), and 17 in our infectious diseases ward (IDW). The 10-day course of remdesivir was completed by 22 patients (63 %) and discontinued by 13, of whom eight (22.8 %) discontinued because of adverse events. The median follow-up was 39 days (IQR 25-44). At day 28, 14 (82.3 %) patients from IDW were discharged, two were still hospitalized and one died (5.9 %), whereas in ICU 6 (33.3 %) were discharged, 8 (44.4 %) patients died, three (16.7 %) were still mechanically ventilated and one (5.6 %) was improved but still hospitalized. Hypertransaminasemia and acute kidney injury were the most frequent severe adverse events observed (42.8 % and 22.8 % of the cases, respectively). Our data suggest that remdesivir can benefit patients with SARS-CoV-2 pneumonia hospitalised outside ICU where clinical outcome was better and adverse events are less frequently observed. Ongoing randomised controlled trials will clarify its real efficacy and safety, who to treat, and when.
SARS-CoV-2 在全球范围内导致的死亡人数不断增加,因为目前尚无有效的治疗方法。瑞德西韦已显示出体外抗冠状病毒活性,是治疗 SARS-CoV-2 感染的一种可能的抗病毒药物。这项在意大利米兰 Luigi Sacco 医院进行的、针对瑞德西韦的前瞻性(同情用药)、开放标签研究,纳入了年龄≥18 岁、正在接受机械通气或在空气中氧饱和度≤94%或国家早期预警评分 2 为≥4 的 SARS-CoV-2 肺炎患者。主要结局是基于 7 级有序量表的临床状态变化(1=未住院,恢复正常日常活动;7=死亡)。2020 年 2 月 23 日至 3 月 20 日期间共纳入 35 例患者,其中 18 例在重症监护病房(ICU),17 例在传染病病房(IDW)。22 例(63%)患者完成了 10 天的瑞德西韦疗程,13 例患者停药,其中 8 例(22.8%)因不良事件停药。中位随访时间为 39 天(IQR 25-44)。在第 28 天,IDW 的 14 例(82.3%)患者出院,2 例仍住院,1 例死亡(5.9%),而 ICU 中有 6 例(33.3%)出院,8 例(44.4%)死亡,3 例(16.7%)仍在机械通气,1 例(5.6%)好转但仍住院。最常见的严重不良事件为肝转氨酶升高和急性肾损伤(分别占 42.8%和 22.8%)。我们的数据表明,瑞德西韦可使住院于 ICU 外的 SARS-CoV-2 肺炎患者受益,这些患者的临床结局更好,且不良事件的发生频率较低。正在进行的随机对照试验将阐明其真正的疗效和安全性、治疗对象和治疗时机。