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用于未接种疫苗人群的感冒/流感样症状的免疫酵母发酵产物。

Immunogenic yeast-based fermentate for cold/flu-like symptoms in nonvaccinated individuals.

机构信息

Department of Urology, University of Michigan Medical Center, Ann Arbor, MI, USA.

出版信息

J Altern Complement Med. 2010 Feb;16(2):213-8. doi: 10.1089/acm.2009.0310.

Abstract

BACKGROUND

The common cold has a profound impact on employee attendance and productivity. Seasonal influenza is responsible for approximately 200,000 hospitalizations and 36,000 deaths per year in the United States alone. Over-the-counter medication efficacy has been questioned, and seasonal vaccination compliance issues abound. Our previously reported randomized trial of an oral fermentation product found an adjuvant benefit for vaccinated individuals in terms of a significantly reduced incidence and duration of cold and flu-like symptoms.

METHODS

A concurrent 12-week, randomized, double-blind, placebo-controlled clinical trial of 116 subjects with no recent history of seasonal influenza vaccination was conducted. Participants received once-daily supplementation with 500 mg of a dried modified Saccharomyces cerevisiae oral fermentate (EpiCor) or placebo. Clinical outcome measurements included periodic interval-based in-clinic examinations and serologic analysis at baseline, 6 weeks, and 12 weeks. Participants utilized a standardized self-report symptom diary.

RESULTS

Subjects receiving the intervention experienced a statistically significant reduction in the incidence (p = 0.01), a nonsignificant reduction in duration (p = 0.10), and no impact on the severity (p = 0.90) of colds or flu-like symptoms, but a more favorable safety profile compared with subjects receiving placebo.

CONCLUSIONS

This nutritional-based fermentate appeared to be safe and efficacious in a unique at-risk population and should receive more clinical research as a potential method to reduce the incidence of cold and flu-like symptoms, in individuals with and without a history of influenza vaccination.

摘要

背景

普通感冒对员工的出勤率和生产力有深远的影响。仅在美国,季节性流感每年就导致约 20 万人住院和 3.6 万人死亡。非处方药物的疗效受到质疑,季节性疫苗接种的合规性问题也层出不穷。我们之前报道的一项口服发酵产品的随机试验发现,对于接种疫苗的个体,该产品具有辅助益处,可显著降低感冒和流感样症状的发生率和持续时间。

方法

一项为期 12 周的同期、随机、双盲、安慰剂对照临床试验纳入了 116 名近期无季节性流感疫苗接种史的受试者。参与者每天接受一次 500 毫克干改良酿酒酵母口腔发酵物(EpiCor)或安慰剂的补充。临床结局测量包括基线、6 周和 12 周时定期间隔的门诊检查和血清学分析。参与者使用标准化的自我报告症状日记。

结果

接受干预的受试者感冒的发生率显著降低(p=0.01),持续时间虽略有降低(p=0.10),但对感冒或流感样症状的严重程度无影响(p=0.90),而与接受安慰剂的受试者相比,安全性更好。

结论

这种基于营养的发酵物在独特的高危人群中似乎是安全且有效的,应作为一种潜在方法,在有或没有流感疫苗接种史的个体中,进一步开展更多的临床研究,以减少感冒和流感样症状的发生率。

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