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姜(Zingiber officinale)根茎提取物治疗 COVID-19 门诊患者的疗效和安全性:一项随机、双盲、安慰剂对照的临床试验。

The efficacy and safety of ginger (Zingiber officinale) rhizome extract in outpatients with COVID-19: A randomized double-blind placebo-control clinical trial.

机构信息

Student Research Committee, Faculty of Pharmacy, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.

Infectious and Tropical Diseases Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.

出版信息

Medicine (Baltimore). 2024 May 31;103(22):e38289. doi: 10.1097/MD.0000000000038289.

DOI:10.1097/MD.0000000000038289
PMID:39259072
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11142819/
Abstract

BACKGROUND

Ginger, a potent antiviral, anti-inflammatory, and antioxidant remedy, is a potential therapeutic option for COVID-19. However, there was not enough clinical evidence about ginger and COVID-19. We evaluated the efficacy and safety of ginger on clinical and paraclinical features in outpatients with COVID-19.

METHODS

In this randomized controlled trial, the outpatients with confirmed COVID-19 were randomly assigned in a 1:1 ratio to receive ginger (1000 mg 3 times a day for 7 days) or placebo. The primary outcome was viral clearance after the end of the intervention. Oxygen saturation (SPO2), body temperature, respiratory rate (RR), hospital admission, and the incidence of adverse events were also assessed.

RESULTS

A total of 84 patients (42 in the ginger and 42 in the control groups) were randomized. The viral clearance was not statistically improved in the ginger group (41.6%) compared to the placebo group (42.8%). The findings indicated that SPO2, body temperature, and RR had no significant difference between the groups at the end of the intervention. The imaging finding indicated pulmonary infiltrate significantly reduced on the 7th day of the intervention in the ginger group. The percentage of patients with SPO2 <96% in the ginger group decreased over the study compared to the placebo group. Moreover, the need for hospital admission and the incidence of adverse drug events were not different between the groups over the follow-up period.

CONCLUSIONS

Ginger had no significant impact on the clinical and paraclinical parameters of patients. However, this intervention demonstrated a safe profile of adverse events and reduced pulmonary infiltrate.

TRIAL REGISTRATION

The trial was registered as IRCT20200506047323N1.

摘要

背景

姜是一种有效的抗病毒、抗炎和抗氧化药物,是治疗 COVID-19 的潜在选择。然而,关于姜和 COVID-19 的临床证据不足。我们评估了姜对门诊 COVID-19 患者临床和辅助检查特征的疗效和安全性。

方法

在这项随机对照试验中,将确诊的 COVID-19 门诊患者以 1:1 的比例随机分为姜组(每天 3 次,每次 1000mg,共 7 天)或安慰剂组。主要结局是干预结束后病毒清除情况。还评估了血氧饱和度(SPO2)、体温、呼吸频率(RR)、住院和不良事件的发生率。

结果

共有 84 名患者(姜组 42 名,对照组 42 名)被随机分组。与安慰剂组(42.8%)相比,姜组的病毒清除率并无统计学上的改善(41.6%)。研究结果表明,干预结束时两组的 SPO2、体温和 RR 无显著差异。影像学检查结果表明,干预第 7 天,姜组的肺部浸润明显减少。与安慰剂组相比,姜组的 SPO2<96%的患者比例在研究过程中逐渐下降。此外,在随访期间,两组的住院需求和不良药物事件发生率无差异。

结论

姜对患者的临床和辅助检查参数无显著影响。然而,这种干预措施显示出了安全的不良事件谱,并减少了肺部浸润。

试验注册

该试验注册为 IRCT20200506047323N1。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3943/11142819/43eafc3d529a/medi-103-e38289-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3943/11142819/4f4accc353a1/medi-103-e38289-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3943/11142819/43eafc3d529a/medi-103-e38289-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3943/11142819/4f4accc353a1/medi-103-e38289-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3943/11142819/43eafc3d529a/medi-103-e38289-g002.jpg

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