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关于三种传统克里特岛草药提取物对上呼吸道感染疗效的报告:一项双盲随机对照试验的结果

Reporting effectiveness of an extract of three traditional Cretan herbs on upper respiratory tract infection: results from a double-blind randomized controlled trial.

作者信息

Duijker G, Bertsias A, Symvoulakis E K, Moschandreas J, Malliaraki N, Derdas S P, Tsikalas G K, Katerinopoulos H E, Pirintsos S A, Sourvinos G, Castanas E, Lionis C

机构信息

Clinic of Social and Family Medicine, School of Medicine, University of Crete, PO Box 2208, Heraklion 71003, Greece.

Department of Social Medicine, School of Medicine, University of Crete, Heraklion, Greece.

出版信息

J Ethnopharmacol. 2015 Apr 2;163:157-66. doi: 10.1016/j.jep.2015.01.030. Epub 2015 Jan 30.

DOI:10.1016/j.jep.2015.01.030
PMID:25645191
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7127758/
Abstract

ETHNOPHARMACOLOGICAL RELEVANCE

Observations from the island of Crete, Greece suggest that infusions of traditional Cretan aromatic plants, well known for their ethnopharmacological use in Eastern Mediterranean region and Near East, could be effective in the prevention and treatment of upper respiratory tract infections, including viral-induced infections. The aim of this study was to report the effectiveness of an essential-oil extract of three Cretan aromatic plants in the treatment of cases with an upper respiratory tract infection.

MATERIALS AND METHODS

A double blind randomized controlled trial was implemented between October 2013 and February 2014. An essential-oil extract of Cretan aromatic plants in olive oil (total volume of 15ml of essential oil per litre of olive oil) was administered as 0.5ml soft gel capsules, twice a day, for 7 days. Placebo treatment was 0.5ml olive oil in soft gel capsules. Eligible patients were those presenting for clinical examination in the selected setting with signs and symptoms of upper respiratory tract infection that had begun within the previous 24 hours. Real-Time Polymerase Chain Reaction (PCR) was used for the detection of respiratory viruses. The primary outcome was the severity and duration of symptoms of upper respiratory tract infection, assessed using the Wisconsin Upper Respiratory System Survey (WURSS-21) questionnaire. A secondary outcome of interest was the change in C-reactive protein (CRP) status.

RESULTS

One hundred and five patients completed the study: 51 in the placebo group, and 54 in the intervention (treated) group. Baseline characteristics were similar in the two groups. No statistically significant differences were found in symptom duration or severity between the two groups, although small and clinically favorable effects were observed. When the analysis was restricted to subjects with a laboratory-documented viral infection, the percentage of patients with cessation of symptoms after 6 days of treatment was 91% in the intervention group and 70% in the control group (p=0.089). At baseline, one third of the patients in each group had elevated CRP levels. At follow-up, the respective proportions were 0% in the intervention group and 15% in the placebo group (p=0.121). The data were also in a favorable direction when 50% and 80% symptom reduction points were considered for specific virus types.

CONCLUSIONS

Compared with placebo the essential-oil extract of three Cretan aromatic plants provided no detectable statistically significant benefit or harm in the patients with upper respiratory illness, although descriptive differences were identified in favorable direction mainly in the virus-positive population.

摘要

民族药理学相关性

来自希腊克里特岛的观察结果表明,传统的克里特芳香植物提取物,在东地中海地区和近东地区以民族药理学用途而闻名,可能对预防和治疗上呼吸道感染有效,包括病毒引起的感染。本研究的目的是报告三种克里特芳香植物的精油提取物对上呼吸道感染病例的治疗效果。

材料与方法

在2013年10月至2014年2月期间进行了一项双盲随机对照试验。将克里特芳香植物的精油提取物溶于橄榄油中(每升橄榄油中精油总体积为15ml),制成0.5ml软胶囊,每天服用两次,共7天。安慰剂治疗为0.5ml橄榄油软胶囊。符合条件的患者是那些在选定环境中接受临床检查,有上呼吸道感染体征和症状且在过去24小时内发病的患者。采用实时聚合酶链反应(PCR)检测呼吸道病毒。主要结局是使用威斯康星上呼吸道系统调查问卷(WURSS - 21)评估的上呼吸道感染症状的严重程度和持续时间。一个感兴趣的次要结局是C反应蛋白(CRP)状态的变化。

结果

105名患者完成了研究:安慰剂组51名,干预(治疗)组54名。两组的基线特征相似。两组在症状持续时间或严重程度上未发现统计学显著差异,尽管观察到了微小且临床上有利的效果。当分析仅限于实验室记录有病毒感染的受试者时,治疗6天后症状消失的患者百分比在干预组为91%,在对照组为70%(p = 0.089)。基线时,每组三分之一的患者CRP水平升高。随访时,干预组相应比例为0%,安慰剂组为15%(p = 0.121)。当考虑特定病毒类型症状减轻50%和80%的点时,数据也呈有利趋势。

结论

与安慰剂相比,三种克里特芳香植物的精油提取物在患有上呼吸道疾病的患者中未显示出可检测到的统计学显著益处或危害,尽管在主要为病毒阳性人群中发现了在有利方向上的描述性差异。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d4e/7127758/6e2d2d40e0ae/gr6_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d4e/7127758/e9b1656166e5/fx1_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d4e/7127758/41afe0148736/gr1_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d4e/7127758/f68e40addc56/gr2_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d4e/7127758/4269db1138fe/gr3_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d4e/7127758/cee2b193cfc6/gr4_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d4e/7127758/edb67455faae/gr5_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d4e/7127758/6e2d2d40e0ae/gr6_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d4e/7127758/e9b1656166e5/fx1_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d4e/7127758/41afe0148736/gr1_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d4e/7127758/f68e40addc56/gr2_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d4e/7127758/4269db1138fe/gr3_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d4e/7127758/cee2b193cfc6/gr4_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d4e/7127758/edb67455faae/gr5_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d4e/7127758/6e2d2d40e0ae/gr6_lrg.jpg

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