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纳米姜黄素作为 COVID-19 住院患者附加治疗的疗效:一项双盲、随机临床试验。

Efficacy of Nanocurcumin as an Add-On Treatment for Patients Hospitalized with COVID-19: A Double-Blind, Randomized Clinical Trial.

机构信息

Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran.

Department of Internal Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.

出版信息

Int J Clin Pract. 2023 Jul 28;2023:5734675. doi: 10.1155/2023/5734675. eCollection 2023.

Abstract

BACKGROUND

Curcumin is a polyphenol derivative of the rhizome, with potential antioxidant, anticancer, antidepressant, antiviral, and anti-inflammatory effects. This compound can be prepared as biodegradable polymer nanoparticles, called nanocurcumin, to improve its solubility, stability, half-life, and bioavailability.

AIM

We explored nanocurcumin's effect on the clinical manifestations of patients hospitalized with mild-to-moderate COVID-19.

METHODS

This double-blind, randomized clinical trial involved 76 COVID-19 patients admitted to Ali-Asghar Hospital from December 2021 to March 2022. All patients received standard coronavirus treatment as per national guidelines. In addition, four times a day for two weeks, the curcumin group received 40 mg of nanocurcumin, while the control group received a placebo. Clinical manifestations were examined and recorded by the associate doctors working in the department. Statistical analysis was done using SPSS v. 21.

RESULTS

Thirty-nine people from the control group and 29 from the curcumin group completed the study. At baseline, the groups were comparable in age, gender, body mass index, hospitalization duration, and background diseases. The mean age of patients in the control and treatment groups was 53.9 ± 11.9 and 54.6 ± 13.4, respectively. Compared with the placebo, nanocurcumin minimized coughs (=0.036), fatigue (=0.0001), myalgia (=0.027), oxygen demand (=0.036), oxygen usage (=0.05), and respiratory rate ( < 0.0001). By discharge, the curcumin group had a significantly greater increase in SPO than the control group (=0.006).

CONCLUSIONS

This preliminary study suggests that nanocurcumin has a potentiating anti-inflammatory effect when combined with standard COVID-19 treatment, helping the recovery from the acute inflammatory phase of the disease in hospitalized patients with mild-to-moderate disease severity. This trial is registered with Iranian Registry of Clinical Trials: IRCT20211126053183N1 (registered while recruiting on 13/12/2021).

摘要

背景

姜黄素是姜黄根茎中的多酚衍生物,具有潜在的抗氧化、抗癌、抗抑郁、抗病毒和抗炎作用。这种化合物可以被制备成可生物降解的聚合物纳米粒子,称为纳米姜黄素,以提高其溶解度、稳定性、半衰期和生物利用度。

目的

我们探讨了纳米姜黄素对因轻度至中度 COVID-19 住院的患者临床表现的影响。

方法

这是一项双盲、随机临床试验,涉及 2021 年 12 月至 2022 年 3 月期间从阿里阿斯加尔医院住院的 76 名 COVID-19 患者。所有患者均按照国家指南接受标准的冠状病毒治疗。此外,在两周内每天四次,姜黄素组接受 40 毫克纳米姜黄素,而对照组接受安慰剂。临床症状由在该科室工作的副主任医师进行检查和记录。使用 SPSS v. 21 进行统计分析。

结果

对照组有 39 人,姜黄素组有 29 人完成了研究。在基线时,两组在年龄、性别、体重指数、住院时间和基础疾病方面无差异。对照组和治疗组患者的平均年龄分别为 53.9±11.9 岁和 54.6±13.4 岁。与安慰剂相比,纳米姜黄素可减轻咳嗽(=0.036)、疲劳(=0.0001)、肌痛(=0.027)、对氧气的需求(=0.036)、氧气使用(=0.05)和呼吸频率( < 0.0001)。出院时,姜黄素组的 SpO 较对照组显著增加(=0.006)。

结论

这项初步研究表明,纳米姜黄素与标准 COVID-19 治疗联合使用具有增强的抗炎作用,有助于住院的轻度至中度疾病严重程度患者从疾病的急性炎症期恢复。该试验在伊朗临床试验注册中心注册:IRCT20211126053183N1(于 2021 年 12 月 13 日注册招募)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/debd/10403319/545ab4281fa9/IJCLP2023-5734675.001.jpg

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