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高危、非住院的轻症至中度 COVID-19 成人患者使用阿兹夫定治疗的真实世界研究结果。

Oral azvudine for mild-to-moderate COVID-19 in high risk, nonhospitalized adults: Results of a real-world study.

机构信息

Department of Pharmacy, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.

Department of Respiratory and Critical Care Medicine, Beijing Chao-Yang Hospital, Beijing Institute of Respiratory Medicine, Capital Medical University, Beijing, China.

出版信息

J Med Virol. 2023 Jul;95(7):e28947. doi: 10.1002/jmv.28947.

Abstract

Azvudine is recommended by Chinese health authorities for COVID-19 treatment but has not been tested in real-world clinical studies. This study aimed to evaluate the real-world effectiveness of Azvudine among COVID-19 nonhospitalized patients. This was a retrospective cohort study, looking at nonhospitalized patients who tested positive for SARS-CoV-2. Patients admitted between December 19, 2022 and January 5, 2023 were included. Those who received Azvudine treatment were in the Azvudine group, while those who received supportive treatment were the control group. The primary outcome was the disease progression rate by Day 28. Secondary outcomes were individual disease progression outcomes (death or COVID-19-related hospitalization) and duration of fever. The safety outcomes were assessed based on adverse events (AEs) overall, as well as AEs that were considered to be related to the drug. A total of 804 patients with high risk for progression were enrolled in our study. Among them, 317 (39.43%) received treatment with Azvudine. Our study found that Azvudine could reduce the rate of disease progression, as well as rate of COVID-19-related hospitalization in patients comparing the control group. Furthermore, if taken within 3 days of the onset of symptoms, it could also shorten the duration of fever. Despite a higher incidence of drug-related AEs compared to supportive treatment, the majority of these were mild. Azvudine has been found to be effective in reducing the rate of disease progression of COVID-19, albeit with a slight increase in AEs.

摘要

阿兹夫定已被中国卫生部门推荐用于治疗 COVID-19,但尚未在真实世界的临床研究中进行测试。本研究旨在评估阿兹夫定在 COVID-19 非住院患者中的真实世界疗效。这是一项回顾性队列研究,观察了 SARS-CoV-2 检测呈阳性的非住院患者。患者于 2022 年 12 月 19 日至 2023 年 1 月 5 日期间入院。接受阿兹夫定治疗的患者归入阿兹夫定组,而接受支持性治疗的患者归入对照组。主要结局是第 28 天的疾病进展率。次要结局是个体疾病进展结局(死亡或 COVID-19 相关住院)和发热持续时间。安全性结局基于总体不良事件(AE)以及被认为与药物相关的 AE 进行评估。本研究共纳入 804 例疾病进展风险较高的患者。其中,317 例(39.43%)接受了阿兹夫定治疗。我们的研究发现,与对照组相比,阿兹夫定可以降低疾病进展率和 COVID-19 相关住院率。此外,如果在症状出现后 3 天内服用,还可以缩短发热持续时间。尽管与支持性治疗相比,药物相关 AE 的发生率更高,但大多数都是轻度的。阿兹夫定已被证明可以有效降低 COVID-19 的疾病进展率,但 AE 略有增加。

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