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Effectiveness and safety of Xingbei Zhike granules in patients with postinfectious cough: A multicenter, randomized, double-blinded, placebo-controlled trial

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机构: [1]The Second Clinical College of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine), Guangzhou, China. [2]North China University of Science and Technology Affiliated Hospital, China. [3]The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine, China. [4]The First Affiliated Hospital of Henan University of Chinese Medicine, China. [5]Liuzhou Traditional Chinese Medical Hospital, China. [6]The First People's Hospital of Kunshan, China. [7]Shanxi Fenyang Hospital, China. [8]Luohe Traditional Chinese Medicine Hospital, China. [9]Nanyang Traditional Chinese Medicine Hospital, China. [10]Yun Cheng Traditional Chinese Medicine Hospital, China. [11]The Second Hospital of Baoding, China. [12]Changzhi People's Hospital, China. [13]Handan Traditional Chinese Medicine Hospital, China. [14]Maanshan People's Hospital, China. [15]Respiratory Disease Research Committee of China Association of Traditional Chinese Medicine, China. [16]Beijing Yaohai Ningkang Pharmaceutical Technology Co., LTD, China. [17]Harbin Kangsaisi Medical Technology Development Co., LTD, China. [18]The Second Clinical College of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine), Guangzhou, China. [19]The Second Clinical College of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine), Guangzhou, China.
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关键词: Postinfectious cough Xingbei Zhike granules Chinese patent medicine Randomized controlled trial

摘要:
Postinfectious cough (PIC) is a common symptom following a respiratory tract infection. Xingbei Zhike (XBZK) granules, a Chinese patent medicine, has been widely used for PIC in clinics. However, there is a lack of evidence on the effectiveness.To investigate whether treatment with XBZK granules is effective for PIC.A multicenter, randomized, double-blinded, placebo-controlled trial.Eligible participants from fourteen hospitals were randomly assigned in 3:1 ratio to receive either XBZK granules or placebo for 14 days. The primary outcome was the area under the curve (AUC) of a visual analogue scale (VAS) for cough symptoms. Secondary outcomes included cough symptom score (CSS), time and probability of recovery from cough, traditional Chinese medicine (TCM) syndrome score, relief rates of individual symptoms, Leicester Cough Questionnaire (LCQ) score, and the use of reliever drug.A total of 235 patients (176 in XBZK and 59 in placebo groups) were included in the analysis. The AUC for cough VAS scores was lower in the XBZK than placebo group (-8.10, 95 % CI -14.12 to -2.07, p = 0.009), indicating superiority. XBZK decreased CSS (-0.68 points, 95 % CI -1.13 to -0.22, p = 0.01), shortened time to cough recovery (-2 days, hazard ratio [HR] 1.48, 95 % CI 1.03 to 2.13, p = 0.02), enhanced the probability of cough recovery (risk ratio [RR] 1.66, 95 % CI 1.07 to 2.58, p = 0.03), lowered TCM syndrome score (-0.99 points, 95 % CI -1.58 to -0.40, p = 0.004), increased the rate of daytime (RR 1.84, 95 % CI 1.07 to 3.15, p = 0.02) and nighttime (RR 2.07, 95 % CI 1.29 to 3.35, p = 0.004) cough recovery, and reduced the viscosity of sputum (RR 2.92, 95 % CI 1.66 to 5.13, p < 0.001) compared to placebo. There were no significant differences in LCQ scores and taking reliever drugs between groups. No severe adverse events were reported in either group.XBZK granules are a promising therapy against PIC, effective in lowering the overall severity of cough, shortening the time to cough recovery, and reducing the viscosity of sputum.Copyright © 2023 Elsevier GmbH. All rights reserved.

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出版当年[2022]版:
大类 | 1 区 医学
小类 | 1 区 药物化学 1 区 药学 1 区 全科医学与补充医学 1 区 植物科学
最新[2025]版:
大类 | 1 区 医学
小类 | 1 区 药物化学 1 区 全科医学与补充医学 1 区 药学 1 区 植物科学
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出版当年[2021]版:
Q1 CHEMISTRY, MEDICINAL Q1 INTEGRATIVE & COMPLEMENTARY MEDICINE Q1 PHARMACOLOGY & PHARMACY Q1 PLANT SCIENCES
最新[2023]版:
Q1 CHEMISTRY, MEDICINAL Q1 INTEGRATIVE & COMPLEMENTARY MEDICINE Q1 PHARMACOLOGY & PHARMACY Q1 PLANT SCIENCES

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第一作者机构: [1]The Second Clinical College of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine), Guangzhou, China.
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