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氟伏沙明治疗轻症至中症 COVID-19 患者的真实世界疗效:一项历史性队列研究(氟伏沙明试验)。

The real-world effectiveness of fluvoxamine therapy in mild to moderate COVID-19 patients; A historical cohort study (Fluvoxa Trial).

机构信息

Division of Infectious Diseases, Department of Medicine, Chulabhorn Hospital, Chulabhorn Royal Academy, Bangkok, Thailand; Princess Srisavangavadhana College of Medicine, Chulabhorn Royal Academy, Bangkok, Thailand.

Division of Infectious Diseases, Department of Medicine, Chulabhorn Hospital, Chulabhorn Royal Academy, Bangkok, Thailand; Princess Srisavangavadhana College of Medicine, Chulabhorn Royal Academy, Bangkok, Thailand.

出版信息

J Infect Public Health. 2023 Dec;16(12):2010-2016. doi: 10.1016/j.jiph.2023.10.010. Epub 2023 Oct 6.

DOI:10.1016/j.jiph.2023.10.010
PMID:37890224
Abstract

BACKGROUND

Fluvoxamine (FVX) has been proposed as a potential treatment for severe COVID-19 by the σ-1 receptor agonist, which can reduce cytokine production. However, the efficacy of FVX remains controversial.

METHODS

A historical retrospective cohort study was conducted in mild to moderate COVID-19 patients, 2:1 ratio of standard of care (SOC) and FVX treatments to assess the effectiveness of FVX in preventing deterioration by the fifth day of treatment.

RESULTS

Of 752 eligible patients, 234 received FVX while 518 received SOC, and there was no significant difference in the effectiveness of FVX and SOC in preventing clinical deterioration. On the fifth day after treatment, 86.1 % of patients in the FVX-treated group did not experience clinical deterioration compared to 78.7 % in the SOC group. Notably, the FVX group had higher rates of pneumonia development and hospitalization, requiring more oxygen supplementation while showing less reduction in viral shedding than the SOC group. However, no difference in mechanical ventilation use, ICU admission, and survival was observed.

CONCLUSION

Fluvoxamine treatment is failed to demonstrate effectiveness in preventing deterioration in mild to moderate COVID-19 and may lead to a higher incidence of pneumonia, hospitalization, and oxygen supplementation, necessitating careful consideration before prescribing the drug for COVID-19.

摘要

背景

σ-1 受体激动剂可减少细胞因子的产生,因此被提议将氟伏沙明(FVX)作为治疗严重 COVID-19 的潜在方法。然而,FVX 的疗效仍存在争议。

方法

对轻中度 COVID-19 患者进行了一项历史回顾性队列研究,采用标准治疗(SOC)与 FVX 治疗的 2:1 比例,以评估 FVX 在治疗第 5 天预防病情恶化的效果。

结果

在 752 名符合条件的患者中,234 名患者接受了 FVX 治疗,518 名患者接受了 SOC 治疗,FVX 和 SOC 在预防临床恶化方面的效果无显著差异。治疗第 5 天,FVX 组中 86.1%的患者未出现临床恶化,而 SOC 组中这一比例为 78.7%。值得注意的是,FVX 组发生肺炎和住院的比例更高,需要更多的氧补充,而病毒脱落减少的程度低于 SOC 组。然而,两组在使用机械通气、入住 ICU 和生存率方面没有差异。

结论

氟伏沙明治疗未能证明在预防轻中度 COVID-19 恶化方面有效,并且可能导致更高的肺炎、住院和氧补充发生率,在为 COVID-19 开具该药物之前需要仔细考虑。

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