高剂量补充剂对新冠肺炎住院成人患者的影响：一项随机对照试验。

Effect of high-dose supplementation on hospitalized adults with COVID-19: a randomized controlled trial.

作者信息

Aghasadeghi Mohammad Reza, Zaheri Birgani Mohammad Ali, Jamalimoghadamsiyahkali Saeedreza, Hosamirudsari Hadiseh, Moradi Ali, Jafari-Sabet Majid, Sadigh Nooshin, Rahimi Pooneh, Tavakoli Rezvan, Hamidi-Fard Mojtaba, Bahramali Golnaz, Parmoon Zohal, Arjmand Hashjin Sina, Mirzajani Ghasem, Kouhkheil Reza, Roshangaran Somayeh, Khalaf Samineh, Khademi Nadoushan Mohammad, Gholamiyan Yousef Abad Ghazaleh, Shahryarpour Nima, Izadi Mohammad, Zendedel Abolfazl, Jahanfar Shayesteh, Dadras Omid, SeyedAlinaghi SeyedAhmad, Hackett Daniel

机构信息

Hepatitis and AIDS Department, Pasteur Institute of Iran, Tehran, Iran.

Viral Vaccine Research Center, Pasteur Institute of Iran, Tehran, Iran.

出版信息

Front Immunol. 2024 Apr 8;15:1332425. doi: 10.3389/fimmu.2024.1332425. eCollection 2024.

DOI:10.3389/fimmu.2024.1332425

PMID:38655258

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11036872/

Abstract

OBJECTIVE

() is a cyanobacterium proven to have anti-inflammatory, antiviral, and antioxidant effects. However, the effect of high-dose supplementation on hospitalized adults with COVID-19 is currently unclear. This study aimed to evaluate the efficacy and safety of high-dose for SARS-CoV-2 infection.

STUDY DESIGN

We conducted a randomized, controlled, open-label trial involving 189 patients with COVID-19 who were randomly assigned in a 1:1 ratio to an experimental group that received 15.2g of supplement plus standard treatment (44 non-intensive care unit (non-ICU) and 47 ICU), or to a control group that received standard treatment alone (46 non-ICU and 52 ICU). The study was conducted over six days. Immune mediators were monitored on days 1, 3, 5, and 7. The primary outcome of this study was mortality or hospital discharge within seven days, while the overall discharge or mortality was considered the secondary outcome.

RESULTS

Within seven days, there were no deaths in the group, while 15 deaths (15.3%) occurred in the control group. Moreover, within seven days, there was a greater number of patients discharged in the group (97.7%) in non-ICU compared to the control group (39.1%) (HR, 6.52; 95% CI, 3.50 to 12.17). Overall mortality was higher in the control group (8.7% non-ICU, 28.8% ICU) compared to the group (non-ICU HR, 0.13; 95% CI, 0.02 to 0.97; ICU, HR, 0.16; 95% CI, 0.05 to 0.48). In non-ICU, patients who received showed a significant reduction in the levels of IL-6, TNF-α, IL-10, and IP-10 as intervention time increased. Furthermore, in ICU, patients who received showed a significant decrease in the levels of MIP-1α and IL-6. IFN-γ levels were significantly higher in the intervention group in both ICU and non-ICU subgroups as intervention time increased. No side effects related to supplements were observed during the trial.

CONCLUSION

High-dose supplements coupled with the standard treatment of COVID-19 may improve recovery and remarkably reduce mortality in hospitalized patients with COVID-19.

CLINICAL TRIAL REGISTRATION

https://irct.ir/trial/54375, Iranian Registry of Clinical Trials number (IRCT20210216050373N1).

摘要

目的

（某物质）是一种经证实具有抗炎、抗病毒和抗氧化作用的蓝藻细菌。然而，高剂量补充该物质对新冠肺炎住院成人患者的影响目前尚不清楚。本研究旨在评估高剂量该物质对严重急性呼吸综合征冠状病毒2（SARS-CoV-2）感染的疗效和安全性。

研究设计

我们进行了一项随机、对照、开放标签试验，纳入189例新冠肺炎患者，这些患者按1:1比例随机分配至实验组，接受15.2克该物质补充剂加标准治疗（44例非重症监护病房（非ICU）患者和47例ICU患者），或对照组，仅接受标准治疗（46例非ICU患者和52例ICU患者）。研究持续6天。在第1、3、5和7天监测免疫介质。本研究的主要结局是7天内的死亡率或出院情况，而总体出院或死亡率被视为次要结局。

结果

7天内，实验组无死亡病例，而对照组有15例死亡（15.3%）。此外，7天内，非ICU的实验组出院患者数量（97.7%）多于对照组（39.1%）（风险比，6.52；95%置信区间，3.50至12.17）。对照组的总体死亡率较高（非ICU为8.7%，ICU为28.8%），而实验组（非ICU风险比，0.13；95%置信区间，0.02至0.97；ICU，风险比，0.16；95%置信区间，0.05至0.48）。在非ICU，接受该物质补充的患者随着干预时间的增加，白细胞介素-6（IL-6）、肿瘤坏死因子-α（TNF-α）、白细胞介素-10（IL-10）和干扰素诱导蛋白10（IP-10）水平显著降低。此外，在ICU，接受该物质补充的患者巨噬细胞炎性蛋白-1α（MIP-1α）和IL-6水平显著下降。随着干预时间的增加，ICU和非ICU亚组的干预组干扰素-γ（IFN-γ）水平均显著升高。试验期间未观察到与该物质补充剂相关的副作用。