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한의약융합데이터센터


근거중심한의약 DB

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Title

Chinese herbal medicine formula for acute asthma: A multi-center, randomized, double-blind, proof-of-concept trial.

Authors

Zhang HP, Wang L, Wang Z, Xu XR, Zhou XM, Liu G, He LY, Wang J, Hsu A, Li WM, Wang G.

Journal

Respir Med.

Year

2018

Vol (Issue)

140

Page

42-9.

doi

10.1016/j.rmed.2018.05.014.

PMID

29957279

Url

http://www.ncbi.nlm.nih.gov/pubmed/29957279

MeSH

Acute Disease
Adolescent
Adult
Aged
Albuterol/administration & dosage
Anti-Asthmatic Agents/adverse effects
Anti-Asthmatic Agents/therapeutic use*
Asthma/drug therapy*
Asthma/immunology
Asthma/physiopathology
Biomarkers/blood
Bronchodilator Agents/administration & dosage
Cytokines/blood
Double-Blind Method
Drug Administration Schedule
Drug Therapy, Combination
Drugs, Chinese Herbal/adverse effects
Drugs, Chinese Herbal/therapeutic use*
Female
Humans
Male
Middle Aged
Peak Expiratory Flow Rate/drug effects
Proof of Concept Study
Severity of Illness Index
Young Adult

Keywords

Chinese herbal medicine formula; Acute asthma; Randomized controlled trial; Inflammatory cytokines; Proof-of-concept

한글 키워드

중약 처방; 급성 천식; 무작위배정 비교 임상시험; 염증성 사이토카인; 개념 증명

KMCRIC
Summary & Commentary

KMCRIC 비평 보기 +

Korean Study

Abstract

BACKGROUND:
Despite advances in asthma management, exacerbations constitute a significant health economic burden.

OBJECTIVE:
To observe the efficacy and safety of Chinese herbal medicine formula entitled PingchuanYiqi (PCYQ) granule, on acute asthma and to explore its possible mechanism.

MATERIALS AND METHODS:
This proof-of-concept study consisted of a randomized, double-blind, placebo-controlled trial in patients with acute asthma (n = 300). Participants with acute mild-to-moderate asthma recruited from seven centers in China were randomly assigned to receive PCYQ or placebo. The primary outcomes were PEF (L/min) and total asthma symptom scores. Furthermore, a panel of cytokines including serum IL-4, IL-5, IL-6, IL-8, IL-1β, IL-17A, IFN-α, IFN-β, IFN-γ, CRP, CCL-5, IP-10, and PGD2 levels was detected using ELISA.

RESULTS:
The PCYQ (n = 139) significantly improved the morning PEF on day 4 (349.73 ± 93.92 vs. 313.56 ± 92.91 L/min, P = 0.004) and day 7 (360.42 ± 94.39 vs. 329.52 ± 95.97 L/min, P = 0.023), and the evening PEF on day 4 (352.65 ± 95.47 vs. 320.58 ± 95.30 L/min, P = 0.012) and day 7 (360.42 ± 94.39 vs. 336.86 ± 95.59 L/min, P = 0.029) in comparison with the placebo (n = 143). The PCYQ also improved the clinical symptoms scores and reduced the puffs of short-acting β2-agonist (all P < 0.05). Furthermore, the PCYQ statistically reduced IL-5, IL-8, IL-1β and PGD2 in serum.

CONCLUSION:
The PCYQ as the Chinese herbal medicine formula significantly improves lung function and symptoms of acute asthma, and reduces SABA dosage possibly via decrease of inflammatory biomarkers such as IL-5, IL-8, IL-1β and PGD2.

TRIAL REGISTRATION:
ISRCTN61674768 (http://www.isrctn.com/).

Copyright © 2018. Published by Elsevier Ltd.

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