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阿托伐他汀与安慰剂对2019冠状病毒病重症监护病房患者的疗效比较:一项随机对照试验

Comparative Efficacy of Atorvastatin and Placebo in Intensive Care Unit Patients with Coronavirus Disease 2019: A Randomized Controlled Trial.

作者信息

Taghavi Fatemeh, Abbasi Saeed, Nejati Malihe, Farsaei Shadi

机构信息

Department of Clinical Pharmacy and Pharmacy Practice, Isfahan University of Medical Sciences, Isfahan, Iran.

Anesthesiology and Critical Care Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.

出版信息

J Res Pharm Pract. 2025 Apr 24;13(4):101-110. doi: 10.4103/jrpp.jrpp_10_25. eCollection 2024 Oct-Dec.


DOI:10.4103/jrpp.jrpp_10_25
PMID:40432837
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12105768/
Abstract

OBJECTIVE: Statins, recognized for their lipid-lowering properties, are being studied in clinical studies for potential benefits in treating coronavirus disease 2019 (COVID-19). This clinical trial evaluated the efficacy of a moderate dose of atorvastatin in influencing the clinical response among critically ill COVID-19 patients. METHODS: This investigation involved adult individuals diagnosed with laboratory-confirmed COVID-19 and experiencing critical illness. Patients meeting the eligibility criteria and receiving atorvastatin were allocated to continue treatment at a daily dosage of 20 mg (PHA). In contrast, the remaining eligible patients were randomly assigned to the atorvastatin intervention (AIN: administration of 20 mg atorvastatin daily) and control groups. Patients followed up for 14 days for the primary endpoints of the COVID-19 severity and APACHE II scores. The secondary endpoints and different biochemical parameters were also assessed. FINDINGS: Finally, 116 people completed the study. The studied groups had no significant differences regarding the demographic and basic clinical data. C-reactive protein on the 7 and 14 days in the AIN and PHA groups was significantly lower than in the control group ( = 0.008 and = 0.018). IL6 on the 7 day ( = 0.04) showed a significant decrease in AIN compared to PHA and control groups. However, no significant differences in APACHE-II score and disease severity were detected between the groups. CONCLUSION: Atorvastatin could effectively reduce inflammation in intensive care unit (ICU) patients admitted for COVID-19 management, but it could not influence the clinical outcomes. We suggested investigating its effect on COVID-19 in larger sample sizes, nonICU patients, and from the beginning of the diagnosis for a longer duration.

摘要

目的:他汀类药物因其降脂特性而闻名,目前正在临床研究中探讨其在治疗2019冠状病毒病(COVID-19)方面的潜在益处。本临床试验评估了中等剂量阿托伐他汀对重症COVID-19患者临床反应的影响。 方法:本研究纳入了经实验室确诊为COVID-19且病情危重的成年患者。符合入选标准并接受阿托伐他汀治疗的患者被分配继续每日服用20毫克的治疗方案(PHA)。相比之下,其余符合条件的患者被随机分配至阿托伐他汀干预组(AIN:每日服用20毫克阿托伐他汀)和对照组。对患者进行14天的随访,以观察COVID-19严重程度和急性生理与慢性健康状况评分系统II(APACHE II)评分等主要终点指标。同时还评估了次要终点指标和不同的生化参数。 研究结果:最终,116人完成了研究。各研究组在人口统计学和基本临床数据方面无显著差异。AIN组和PHA组在第7天和第14天的C反应蛋白水平显著低于对照组(P = 0.008和P = 0.018)。与PHA组和对照组相比,AIN组在第7天的白细胞介素6(IL6)水平显著降低(P = 0.04)。然而,各组之间在APACHE-II评分和疾病严重程度方面未检测到显著差异。 结论:阿托伐他汀可有效减轻因COVID-19入院的重症监护病房(ICU)患者的炎症反应,但对临床结局无影响。我们建议在更大样本量、非ICU患者以及从诊断开始的更长时间段内研究其对COVID-19的影响。

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Comparative Efficacy of Atorvastatin and Placebo in Intensive Care Unit Patients with Coronavirus Disease 2019: A Randomized Controlled Trial.

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本文引用的文献

[1]
Atorvastatin versus Placebo in ICU Patients with COVID-19: Ninety-day Results of the INSPIRATION-S Trial.

Thromb Haemost. 2023-7

[2]
Statin and aspirin as adjuvant therapy in hospitalised patients with SARS-CoV-2 infection: a randomised clinical trial (RESIST trial).

BMC Infect Dis. 2022-7-9

[3]
Atorvastatin versus placebo in patients with covid-19 in intensive care: randomized controlled trial.

BMJ. 2022-1-7

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J Am Coll Cardiol. 2021-10-19

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Atorvastatin therapy in COVID-19 adult inpatients: A double-blind, randomized controlled trial.

Int J Cardiol Heart Vasc. 2021-10

[6]
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Int J Infect Dis. 2021-9

[7]
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Adv Exp Med Biol. 2021

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PLoS One. 2021

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The use of statins was associated with reduced COVID-19 mortality: a systematic review and meta-analysis.

Ann Med. 2021-12

[10]
Low HDL and high triglycerides predict COVID-19 severity.

Sci Rep. 2021-3-30

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