β-葡聚糖增强气虚者的正气——一项随机、安慰剂对照和双盲试验

Jun-rong WU; Hao-jie CHENG; Jian-pin SHI; Wei-dong YIN; Jun WANG; Xuan-qiao OU; Jin-li CHEN; Ira Bernstein; Mark Levy; Rolando Maddela; Robert Sinnott; Jun-qiang TIAN

doi:10.1007/s11655-021-3444-0

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β-葡聚糖增强气虚者的正气——一项随机、安慰剂对照和双盲试验

Original Article | Updated：2022-06-27

- β-葡聚糖增强气虚者的正气——一项随机、安慰剂对照和双盲试验
- β-Glucan Improves Protective Qi Status in Adults with Protective Qi Deficiency—A Randomized,Placebo-Controlled, and Double-Blinded Trial
- Chinese Journal of Integrative Medicine 2022年28卷第5期页码：394-402
- Affiliations：
  
  1.Elegant and Olive Health Clinic, Markham, ON, L3R 5V6, Canada
  2.Research and Development Department,USANA Health Science, Inc., Salt Lake City, UT, 84121, USA
  3.Department of Family and Community Medicine, University of Toronto, Toronto, ON, M5T 2S8, Canada
- Author bio：
  
  Dr. TIAN Jun-qiang, E-mail: jeremy.tian@usanainc.com
- Funds：
  
  USANA Health Science Inc., the manufacturer of Proglucamune®
- DOI：10.1007/s11655-021-3444-0
  中图分类号：
- 纸质出版日期：2022-05-01，
  
  网络出版日期：2021-05-08，
  
  录用日期：2020-11-18
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Jun-rong WU, Hao-jie CHENG, Jian-pin SHI, 等. β-葡聚糖增强气虚者的正气——一项随机、安慰剂对照和双盲试验[J]. Chinese Journal of Integrative Medicine, 2022,28(5):394-402.

Jun-rong WU, Hao-jie CHENG, Jian-pin SHI, et al. β-Glucan Improves Protective Qi Status in Adults with Protective Qi Deficiency—A Randomized,Placebo-Controlled, and Double-Blinded Trial[J]. Chinese Journal of Integrative Medicine, 2022,28(5):394-402.
Jun-rong WU, Hao-jie CHENG, Jian-pin SHI, 等. β-葡聚糖增强气虚者的正气——一项随机、安慰剂对照和双盲试验[J]. Chinese Journal of Integrative Medicine, 2022,28(5):394-402. DOI： 10.1007/s11655-021-3444-0.

Jun-rong WU, Hao-jie CHENG, Jian-pin SHI, et al. β-Glucan Improves Protective Qi Status in Adults with Protective Qi Deficiency—A Randomized,Placebo-Controlled, and Double-Blinded Trial[J]. Chinese Journal of Integrative Medicine, 2022,28(5):394-402. DOI： 10.1007/s11655-021-3444-0.

摘要

目的:

中医学说中的正气为在体表循环的抵御外邪的第一道防线

本研究旨在验证β-葡聚糖增强中医正气的假说.

方法:

纳入 138 名气虚成年人

随机分配接受 β-葡聚糖 (200 mg/日) 或安慰剂

共干预 12 周. 每 2 周通过常规诊断和标准化方案评估参与者的正气状态

比较两组气虚者的严重性评分和风险评分

并监测参与者的免疫和一般健康状况指数

包括上呼吸道感染 (URTI)、唾液分泌 IgA

以及自我报告的身心健康指标 (PROMIS).

结果:

β-葡聚糖和安慰剂治疗组基线气虚状态未见显著差异

但干预后与安慰剂组比较

β-葡聚糖组的气虚状态呈时间依赖性显著增强. 干预结束时

两组气虚者的严重性评分、风险评分及气虚者占比差异分别为 0.49 (95% CI 0.35-0.62)、0.48 (95% CI 0.35–0.61) 和 0.36 (95% CI 0.25–0.47). 此外

β-葡聚糖将气虚者的URTI 症状、 PROMIS 身体和精神评分分别提高了 1.0 (95% CI 0.21-1.86) 、5.7 (95% CI 2.33–9.07) 和 3.0 (95% CI –0.37–6.37)

显著高于安慰剂组.

结论:

β-葡聚糖可增强气虚者的正气. 本研究表明通过严格的循证方法证明了西药衍生疗法

如β-葡聚糖

可用于推进中医治疗. (注册号: NCT03782974

ClinicalTrial.Gov)

Abstract

Objective:

To test the hypothesis that β-glucan enhances protective qi (PQi)

an important Chinese medicine (CM) concept which stipulates that a protective force circulates throughout the body surface and works as the first line of defense against "external pernicious influences".

Methods:

A total of 138 participants with PQi deficiency (PQD) were randomized to receive β-glucan (200 mg daily) or placebo for 12 weeks. Participants' PQi status was assessed every 2 weeks via conventional diagnosis and a standardized protocol from which a PQD severity and risk score was derived. Indices of participants' immune and general health status were also monitored

including upper respiratory tract infection (URTI)

saliva secretory IgA (sIgA)

and self-reported measures of physical and mental health (PROMIS).

Results:

PQi status was not significantly different between the β-glucan and placebo treatment groups at baseline but improved significantly in the β-glucan (vs. placebo) group in a time-dependent manner. The intergroup differences [95% confidence interval (CI)] in severity score (scale: 1–5)

risk score (scale: 0-1)

and proportion of PQD participants (%) at finish line was 0.49 (0.35–0.62)

0.48 (0.35–0.61)

and 0.36 (0.25–0.47)

respectively. Additionally

β-glucan improved URTI symptom (scale: 1–9) and PROMIS physical (scale: 16.2–67.7) and mental (scale: 21.2–67.6) scores by a magnitude (95% CI) of 1.0 (0.21–1.86)

5.7 (2.33–9.07)

and 3.0 (–0.37–6.37)

respectively

over placebo.

Conclusions:

β-Glucan ameliorates PQi in PQD individuals. By using stringent evidence-based methodologies

our study demonstrated that Western medicine-derived remedies

such as β-glucan

can be employed to advance CM therapeutics. (ClinicalTrial.Gov registry: NCT03782974)

关键词

Keywords

β-glucanChinese medicineprotective qiprotective qi deficiency

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