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口服纳米姜黄素制剂治疗轻至中度门诊COVID-19的疗效:一项随机三盲安慰剂对照临床试验。

Oral nano-curcumin formulation efficacy in the management of mild to moderate outpatient COVID-19: A randomized triple-blind placebo-controlled clinical trial.

作者信息

Ahmadi Reza, Salari Soofia, Sharifi Mohammad Davood, Reihani Hamidreza, Rostamiani Mohammad Bagher, Behmadi Morteza, Taherzadeh Zhila, Eslami Saeed, Rezayat Seyed Mahdi, Jaafari Mahmoud Reza, Elyasi Sepideh

机构信息

Department of Family Medicine School of Medicine Mashhad University of Medical Sciences Mashhad Iran.

Department of Clinical Pharmacy School of Pharmacy Mashhad University of Medical Sciences Mashhad Iran.

出版信息

Food Sci Nutr. 2021 Jun 19;9(8):4068-4075. doi: 10.1002/fsn3.2226. eCollection 2021 Aug.

DOI:10.1002/fsn3.2226
PMID:34401058
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8358331/
Abstract

BACKGROUND

Curcumin, a natural polyphenolic compound, is proposed as a potential treatment option for patients with coronavirus disease by inhibiting the entry of virus to the cell, encapsulation of the virus and viral protease, as well as modulating various cellular signaling pathways. In this study, the efficacy and safety of nanocurcumin oral formulation has been evaluated in patients with mild-moderate Coronavirus disease 2019 (COVID-19) in outpatient setting.

METHODS

In this triple-blind randomized placebo-controlled clinical trial, sixty mild to moderate COVID-19 patients in outpatient setting who fulfilled the inclusion criteria were randomly allocated to treatment ( = 30) group to receive oral nanocurcumin formulation (Sinacurcumin soft gel which contains 40 mg curcuminoids as nanomicelles), two soft gels twice a day after food for 2 weeks or placebo ( = 30) group. Patients' symptoms and laboratory data were assessed at baseline and during follow-up period and compared between two groups.

RESULTS

All symptoms except sore throat resolved faster in the treatment group and the difference was significant for chills, cough and smell and taste disturbances. The CRP serum level was lower in the treatment group at the end of two weeks and the lymphocyte count was significantly higher in treatment group. No significant adverse reaction reported in the treatment group.

CONCLUSION

Oral nanoformulation of curcumin can significantly improve recovery time in patients with mild to moderate COVID-19 in outpatient setting. Further studies with larger sample size are recommended.

摘要

背景

姜黄素是一种天然多酚化合物,被认为是冠状病毒病患者的一种潜在治疗选择,它可以抑制病毒进入细胞、包裹病毒和病毒蛋白酶,以及调节各种细胞信号通路。在本研究中,已在门诊环境中对纳米姜黄素口服制剂在轻度至中度2019冠状病毒病(COVID-19)患者中的疗效和安全性进行了评估。

方法

在这项三盲随机安慰剂对照临床试验中,将60名符合纳入标准的门诊轻度至中度COVID-19患者随机分配至治疗组(n = 30),接受口服纳米姜黄素制剂(含有40毫克姜黄素类作为纳米胶束的Sinacurcumin软胶囊),每天两次,每次两粒,餐后服用,共2周,或安慰剂组(n = 30)。在基线和随访期间评估患者的症状和实验室数据,并在两组之间进行比较。

结果

治疗组中除喉咙痛外的所有症状缓解更快,寒战、咳嗽以及嗅觉和味觉障碍方面的差异具有统计学意义。两周结束时治疗组的血清CRP水平较低,治疗组的淋巴细胞计数显著更高。治疗组未报告明显不良反应。

结论

姜黄素口服纳米制剂可显著缩短门诊轻度至中度COVID-19患者的恢复时间。建议进行更大样本量的进一步研究。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/543b/8358331/60abe62df149/FSN3-9-4068-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/543b/8358331/60abe62df149/FSN3-9-4068-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/543b/8358331/60abe62df149/FSN3-9-4068-g002.jpg

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