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一项关于使用法匹拉韦联合吸入用干扰素β-1b 治疗中重度 COVID-19 肺炎住院患者的随机对照开放标签试验。

Randomized controlled open label trial on the use of favipiravir combined with inhaled interferon beta-1b in hospitalized patients with moderate to severe COVID-19 pneumonia.

机构信息

Infection Diseases Unit, Department of Medicine, Royal Hospital, Muscat, Oman.

Acute Medicine Unit, Department of Medicine, Royal Hospital, Muscat, Oman.

出版信息

Int J Infect Dis. 2021 Jan;102:538-543. doi: 10.1016/j.ijid.2020.11.008. Epub 2020 Nov 9.

Abstract

OBJECTIVE

To evaluate the therapeutic effectiveness of favipiravir combined with inhaled interferon beta-1b in adult patients hospitalized with moderate to severe COVID-19 pneumonia.

METHODS

A randomized, open-label controlled trial of oral favipiravir in adults hospitalized with moderate to severe COVID-19 pneumonia from June 22nd 2020 to August 13th 2020 was conducted. Patients were randomly assigned to receive either a combination of favipiravir with interferon beta-1b by inhalation aerosol or hydroxychloroquine (HCQ). The outcome endpoints included improvement in inflammatory markers, lower length of hospital stay (LOS), discharges and lower overall 14-day mortality.

RESULTS

A total of 89 patients underwent randomization with 49% (n = 44) assigned to favipiravir and 51% (n = 45) assigned HCQ. The overall mean age was 55 ± 14 years and 58% (n = 52) were males. There were no significant differences in the inflammatory biomarkers at hospital discharge between the two groups; C-reactive protein (p = 0.413), ferritin (p = 0.968), lactate dehydrogenase (p = 0.259) and interleukin 6 (p = 0.410). There were also no significant differences between the two groups with regards to the overall LOS (7 vs 7 days; p = 0.948), transfers to the ICU (18.2% vs 17.8%; p = 0.960), discharges (65.9% vs 68.9%; p = 0.764) and overall mortality (11.4% vs 13.3%; p = 0.778).

CONCLUSIONS

No differences in clinical outcomes were found between favipiravir plus inhaled interferon beta-1b and hydroxychloroquine in adults hospitalized with moderate to severe COVID-19 pneumonia.

摘要

目的

评估在因中度至重度 COVID-19 肺炎住院的成年患者中,使用利巴韦林联合吸入用干扰素-β1b 的治疗效果。

方法

这是一项于 2020 年 6 月 22 日至 8 月 13 日期间开展的、评估口服利巴韦林治疗中度至重度 COVID-19 肺炎成人患者的随机、开放标签对照试验。患者被随机分配接受利巴韦林联合吸入用干扰素-β1b 或羟氯喹(HCQ)治疗。主要结局包括炎症标志物改善、住院时间(LOS)缩短、出院率和 14 天总死亡率降低。

结果

共有 89 例患者接受了随机分组,其中 49%(n=44)的患者接受利巴韦林联合吸入用干扰素-β1b 治疗,51%(n=45)的患者接受 HCQ 治疗。两组患者的平均年龄为 55±14 岁,58%(n=52)为男性。两组患者出院时的炎症标志物无显著差异:C 反应蛋白(p=0.413)、铁蛋白(p=0.968)、乳酸脱氢酶(p=0.259)和白细胞介素 6(p=0.410)。两组患者的 LOS 总时长(7 天 vs 7 天;p=0.948)、转入 ICU(18.2% vs 17.8%;p=0.960)、出院率(65.9% vs 68.9%;p=0.764)和总死亡率(11.4% vs 13.3%;p=0.778)也无显著差异。

结论

在因中度至重度 COVID-19 肺炎住院的成年患者中,利巴韦林联合吸入用干扰素-β1b 与 HCQ 的临床结局无差异。

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