阿托伐他汀治疗轻中度住院COVID-19的疗效:一项随机三盲安慰剂对照临床试验

Sepideh Hejazi, Farzam Mircheraghi, Sepideh Elyasi, Najmeh Davoodian, Davoud Salarbashi, Hasan Mahrad Majd
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引用次数: 10

摘要

背景:他汀类药物是一线降脂药物,不良反应可耐受,成本低,在全球范围内可获得性高。他汀类药物有效的抗炎、抗氧化、抗血栓形成和免疫调节作用使其成为对抗COVID-19感染的一种选择。目的:在这项随机三盲安慰剂对照临床试验中,我们研究了阿托伐他汀治疗轻中度住院COVID-19患者的疗效。方法:本研究将52例符合纳入标准的轻中度住院COVID-19患者分为治疗组(n=26)和安慰剂组(n=26),治疗组口服阿托伐他汀40 mg,每日1次,持续2周。在基线和随访期间评估患者的症状和实验室检查。我们还评估了住院时间和补充氧治疗作为终点。结果:随访14 d后,治疗组血氧饱和度(SaO2)明显高于安慰剂组,血清高敏c反应蛋白(hs-CRP)水平明显低于安慰剂组。此外,治疗组在随访结束时淋巴细胞计数较高,症状缓解时间较短,但不显著。治疗组补充氧疗时间和住院时间均显著缩短。我们的研究结果显示,安慰剂组的死亡率几乎是治疗组的两倍,没有任何明显的药物不良反应。结论:阿托伐他汀可显著降低轻中度住院COVID-19患者的补充耗氧量、住院时间及血清hs-CRP水平。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Atorvastatin Efficacy in the Management of Mild to Moderate Hospitalized COVID-19: A Pilot Randomized Triple-blind Placebo- controlled Clinical Trial.

Background: Statins are first-line lipid-lowering agents with tolerable adverse reactions, low cost, and high availability worldwide. The potent anti-inflammatory, antioxidant, anti-thrombotic and immunomodulatory effects of statins propose them as an option against COVID-19 infection.

Objective: In this randomized triple-blind placebo-controlled clinical trial, we have investigated the atorvastatin efficacy in the management of mild to moderate hospitalized COVID-19 patients.

Methods: In this study, 52 mild to moderate hospitalized COVID-19 patients who fulfilled the inclusion criteria were allocated to the treatment group to receive 40 mg atorvastatin orally once daily for two weeks (n=26) or the placebo group (n=26). Patients' symptoms and laboratory investigations were assessed at baseline and during the follow-up period. We also evaluated the duration of hospitalization and supplemental oxygen therapy as endpoints.

Results: After 14-day of follow-up, the oxygen saturation (SaO2) was significantly higher, and the serum high sensitivity C-reactive protein (hs-CRP) level was lower in the treatment group compared to the placebo group. Moreover, at the end of the followup in the treatment group, the lymphocyte count was higher, and the duration of symptom resolution was shorter but not significant. Additionally, in the treatment group, the length of supplemental oxygen therapy and hospitalization duration were meaningfully shorter. Our results revealed that the mortality rate was almost twice higher in the placebo group compared to the treatment group, without any significant adverse drug reaction.

Conclusion: Atorvastatin significantly reduces supplemental oxygen need, hospitalization duration, and serum hs-CRP level in mild to moderate hospitalized COVID-19 patients.

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