Omega-3脂肪酸在COVID-19危重患者治疗中的附加标准护理（OMEGA-COVID研究），一项随机对照多中心试验

Q3 Nursing

Clinical Nutrition Open Science Pub Date : 2025-09-07 DOI:10.1016/j.nutos.2025.08.011

Ahmed Abd Elaziz Bahey Abd Elbari , Sandro B. Rizoli , Ruben Peralta , Talat Chughtai , Ayman El-Menyar , Hassan Ali Saoud Al Thani , Saibu George , Nadir Kharma , Mohammed Omar Saad , Hasan Mitwally , Mohamed Elkhateeb , Mostafa Elshafi , Ignacio Miguel Gomez Macineira , Anyali Bacallao , Ammar Ibrahim Abed Al-Hassani , Ibrahim Yassin Taha , Judith Jacobi , Airton Leonardo de Oliveira Manoel

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引用次数: 0

摘要

背景：omega-3脂肪酸治疗严重急性呼吸综合征的有效性和安全性仍存在争议。我们评估了在标准护理中加入omega-3脂肪酸是否会改善SARS-CoV-2患者的临床结果。方法：对pcr确诊的成人重症、危重型COVID-19患者进行双盲随机临床试验。患者通过分组分层随机分组，在标准治疗组与单独标准治疗组的基础上，每天两次肠内注射omega-3脂肪酸2g，持续28天。主要终点为第28天无呼吸机天数。次要结局包括ICU和住院时间，以及住院死亡率。结果380例患者（干预组211例，标准护理组169例）。干预组和标准护理组无呼吸机天数相似[平均12.4天（9.3-15.5）vs 11.1天（7.2-15.0），P = 0.48]。ICU的时间（两组均为7天）或住院时间（Omega-3 = 16天，对照组= 15天）均无差异。接受Omega-3脂肪酸治疗的患者有降低死亡率的趋势（4.3% vs 7.7%, P = 0.15）。在预先指定的探索性机械通气患者亚组（89例患者）中，Omega-3组与显著较低的死亡率相关（15.1% vs 33.3%, P = 0.04），然而，该试验无法检测该亚组的死亡率差异。结论在重症或危重型COVID-19患者中，在标准护理中添加Omega-3脂肪酸并没有增加无呼吸机天数。一项探索性分析表明，在需要机械通气的患者中，可能会降低死亡率，但该研究没有为这一终点提供支持，这些发现需要在未来的试验中得到证实。临床试验注册中心，NCT04836052。

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Omega-3 fatty acids in addition to standard of care in the treatment of critically ill patients with COVID-19 (The OMEGA-COVID study), a randomized controlled multicenter trial

Background

The efficacy and safety of omega-3 fatty acid in the treatment of severe acute respiratory syndrome remains controversial. We assessed if the addition of omega-3 fatty acid to standard of care would improve clinical outcomes in patients with SARS-CoV-2.

Methods: double blinded randomized clinical trial of adults with PCR-confirmed severe or critical COVID-19. Patients were enrolled through block stratified randomization to omega-3 fatty acid 2g enterally twice daily for 28 days in addition to standard of care vs. standard of care alone. The primary outcome was ventilator-free days at day 28. Secondary outcomes included length of ICU and hospital stay, and in-hospital mortality.

Results

380 patients (211 in the intervention group and 169 patients in the standard of care group). Ventilator-free days were similar between the intervention and standard of care groups [mean 12.4 days (9.3–15.5) vs 11.1 (7.2–15.0), P = 0.48), respectively]. There was no difference in the length of ICU (7 days for both groups) or hospital stay (Omega-3 = 16 days vs control = 15 days). Patients who received Omega-3 fatty acid had a trend toward lower mortality (4.3% vs 7.7%, P = 0.15). In pre-specified exploratory subgroup of mechanically ventilated patients (89 patients), Omega-3 group was associated with a significantly lower mortality (15.1% vs 33.3%, P = 0.04), however, the trial was not powered to detect mortality differences in this subgroup.

Conclusions

In patients with severe or critical COVID-19, the addition of Omega-3 fatty acids to standard of care did not increase ventilator-free days. An exploratory analysis suggested a possible mortality benefit in patients requiring mechanical ventilation, but the study was not powered for this endpoint, and these findings require confirmation in future trials.