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传统克里特草药提取物对上呼吸道感染的上市后结果:一项实用、前瞻性观察研究。

Post-market outcome of an extract of traditional Cretan herbs on upper respiratory tract infections: a pragmatic, prospective observational study.

机构信息

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

Department of Biology, School of Sciences and Technology, University of Crete, 71003, Heraklion, Greece.

出版信息

BMC Complement Altern Med. 2017 Sep 21;17(1):466. doi: 10.1186/s12906-017-1978-7.

DOI:10.1186/s12906-017-1978-7
PMID:28934952
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5609057/
Abstract

BACKGROUND

The beneficial effects of traditional herbs of Crete, Greece for the treatment of upper respiratory tract infections have been reported in observational and laboratory studies. Following a published, double blind, randomized, placebo controlled trial, this study aimed to assess the effectiveness of an extract of three Cretan herbs on the treatment of upper respiratory tract infections, upon its market release.

METHODS

An observational study was conducted in Heraklion, Crete, Greece. Participants were patients presenting at selected pharmacies with symptoms of upper respiratory tract infection, choosing to receive the extract for their treatment. Patients' symptoms (local, general, total) where recorded at three time points within 1 week, using a questionnaire developed based on the Wisconsin Upper Respiratory System Survey. For each patient, symptoms were scored on a 0-7 Likert scale and three indexes were calculated: the score of local symptoms, the score of general symptoms and the total score of symptoms. Effectiveness was assessed by examining the reduction in these indexes over the 1-week observation period.

RESULTS

Mean score of general symptoms was 19.1 (SE: 0.9) in day 1, dropping to 8.6 (SE: 0.6) and 3.1 (SE: 0.4) in days 4 and 7 respectively. Mean score of local symptoms declined from 7.9 (SE: 0.5) in day 1 to 2.3 (SE: 0.3) in day 4 and to 0.5 (SE: 0.1) in day 7. Total score of symptoms reached 27.0 (SE: 1.2) in day 1, decreasing to 10.9 (SE: 0.8) in day 4 and to 3.5 (SE: 0.5) in day 7. The percentage of participants reporting fever was 82.1% at baseline, 8.0% in day 4 and 2.0% in day 7 (p < 0.0001 for paired differences). Multiple regression models indicated that supplementary medication intake did not seem to affect symptoms' severity or the day patients reported that their symptoms ceased completely.

CONCLUSIONS

This pragmatic study added evidence about the potential therapeutic effects of an extract of Cretan herbs on the amelioration of upper respiratory tract infection symptoms.

摘要

背景

希腊克里特岛的传统草药对治疗上呼吸道感染的有益效果已在观察性和实验室研究中得到报道。在发表了一项双盲、随机、安慰剂对照试验之后,本研究旨在评估三种克里特草药提取物在上市后的上呼吸道感染治疗中的有效性。

方法

在希腊克里特岛的伊拉克利翁进行了一项观察性研究。选择在选定的药店接受该提取物治疗的出现上呼吸道感染症状的患者参与了该研究。患者的症状(局部、全身、总)在一周内的三个时间点使用基于威斯康星州上呼吸道系统调查制定的问卷进行记录。对于每位患者,症状按 0-7 级李克特量表评分,计算三个指标:局部症状评分、全身症状评分和症状总评分。通过检查观察期内这些指标的减少来评估疗效。

结果

第 1 天全身症状的平均评分为 19.1(SE:0.9),第 4 天降至 8.6(SE:0.6),第 7 天降至 3.1(SE:0.4)。局部症状的平均评分从第 1 天的 7.9(SE:0.5)降至第 4 天的 2.3(SE:0.3),再降至第 7 天的 0.5(SE:0.1)。症状总评分在第 1 天达到 27.0(SE:1.2),第 4 天降至 10.9(SE:0.8),第 7 天降至 3.5(SE:0.5)。在基线时报告发热的参与者比例为 82.1%,第 4 天为 8.0%,第 7 天为 2.0%(配对差异的 p 值均<0.0001)。多回归模型表明,补充药物的摄入似乎并不影响症状的严重程度或患者报告症状完全消失的天数。

结论

这项实用研究提供了关于克里特草药提取物对上呼吸道感染症状改善的潜在治疗效果的证据。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bdfd/5609057/acf2db6cadf2/12906_2017_1978_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bdfd/5609057/acf2db6cadf2/12906_2017_1978_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bdfd/5609057/acf2db6cadf2/12906_2017_1978_Fig1_HTML.jpg

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