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曲尼司特辅助治疗住院的重症 COVID-19 患者:一项随机对照试验。

Tranilast as an Adjunctive Therapy in Hospitalized Patients with Severe COVID- 19: A Randomized Controlled Trial.

机构信息

Department of Immunology, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.

Infectious and Tropical Diseases Research Center, Health Research Institute, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran; Infectious Diseases and Tropical Medicine Ward, Razi Teaching Hospital, Ahvaz Jundishapur University of Medical Science, Ahvaz, Iran.

出版信息

Arch Med Res. 2022 Jun;53(4):368-377. doi: 10.1016/j.arcmed.2022.03.002. Epub 2022 Mar 14.

DOI:10.1016/j.arcmed.2022.03.002
PMID:35339280
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8919799/
Abstract

BACKGROUND

Tranilast is a potential NLRP3 inflammasome inhibitor that may relieve progressive inflammation due to COVID-19.

AIM OF THE STUDY

To evaluate the therapeutic effects of Tranilast in combination with antiviral drugs in non-ICU-admitted hospitalized patients with COVID-19.

METHODS

This study was an open-label clinical trial that included 72 hospitals admitted patients with severe COVID-19 at Razi Hospital, Ahvaz, Iran, from July 2020-August 2020. These patients were randomly assigned in a 1:1 ratio to control (30) and intervention groups (30). Patients in the control group received antiviral therapy, while patients in the intervention group received Tranilast (300 mg daily) in addition to the antiviral drugs for Seven days. The collected data, including the expression of inflammatory cytokine, laboratory tests, and clinical findings, was used for intragroup comparisons.

RESULTS

The intervention group showed significantly lower levels of NLR (p = 0.001), q-CRP (p = 0.002), IL-1 (p = 0.001), TNF (p = 0.001), and LDH (p = 0.046) in comparison with the control group. The effect of intervention was significant in increasing the o2 saturation (F = 7.72, p = 0.007). Long hospitalization (four days or above) was 36.6% in the Tranilast and 66.6% in the control group (RR = 0.58; 95% CI: 0.38-1.06, p = 0.045). In the Tranilst and control groups, one and four deaths or hospitalization in ICU were observed respectively (RR = 0.31; 95% CI: 0.03-2.88, p = 0.20).

CONCLUSIONS

Tranilast might be used as an effective and safe adjuvant therapy and enhance the antiviral therapy's efficacy for managing patients with COVID-19.

摘要

背景

曲尼司特是一种潜在的 NLRP3 炎性体抑制剂,可能缓解 COVID-19 引起的进行性炎症。

目的

评估曲尼司特联合抗病毒药物治疗非 ICU 收治的 COVID-19 住院患者的疗效。

方法

这是一项开放标签临床试验,纳入了 2020 年 7 月至 2020 年 8 月期间伊朗阿瓦兹拉齐医院收治的 72 家医院的严重 COVID-19 住院患者。这些患者以 1:1 的比例随机分配到对照组(30 例)和干预组(30 例)。对照组接受抗病毒治疗,而干预组在抗病毒治疗的基础上加用曲尼司特(300mg/d)治疗 7 天。对炎症细胞因子表达、实验室检查和临床发现等采集的数据进行组内比较。

结果

干预组 NLR(p=0.001)、q-CRP(p=0.002)、IL-1(p=0.001)、TNF(p=0.001)和 LDH(p=0.046)水平显著低于对照组。干预组提高 o2 饱和度的效果显著(F=7.72,p=0.007)。曲尼司特组和对照组的住院时间(4 天或以上)分别为 36.6%和 66.6%(RR=0.58;95%CI:0.38-1.06,p=0.045)。曲尼司特组和对照组分别有 1 例和 4 例死亡或入住 ICU(RR=0.31;95%CI:0.03-2.88,p=0.20)。

结论

曲尼司特可作为一种有效且安全的辅助治疗药物,增强抗病毒治疗 COVID-19 患者的疗效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1a41/8919799/84e50cc76cff/gr2_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1a41/8919799/7bb9998eaa2f/gr1_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1a41/8919799/84e50cc76cff/gr2_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1a41/8919799/7bb9998eaa2f/gr1_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1a41/8919799/84e50cc76cff/gr2_lrg.jpg

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