Efficacy of Jia Wei Yang He formula as an adjunctive therapy for asthma: study protocol for a randomized, double blinded, controlled trial.
Efficacy of Jia Wei Yang He formula as an adjunctive therapy for asthma: study protocol for a randomized, double blinded, controlled trial.
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DOI：
10.1186/s13063-018-2739-8
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发表时间：
2018-07-04
期刊：
影响因子：
2.5
通讯作者：
Lu Z
中科院分区：
文献类型：
--
作者：
Jiang W;Ma Z;Zhang H;Lynn HS;Xu B;Zhang X;Bi R;Fu J;Chen Y;Xiao Z;Zhang Z;Lu Z
在过去的二三十年里，哮喘的患病率在世界范围内显著增加；因此，无副作用的有效治疗是至关重要的。中药在减轻哮喘患者的症状和改善患者的生活质量方面起着至关重要的作用。本研究旨在评价加味养和方治疗哮喘的疗效，探讨哮喘患者气道微生物组与中医治疗的关系。这项多中心、平行组、随机、双盲、安慰剂对照试验将评估JWYH在常规治疗哮喘患者中的疗效。无危及生命疾病的持续性哮喘患者将随机入组，并平均分配到高剂量或低剂量JWYH加常规护理组，或安慰剂加常规护理组。随访4个月。因此，240例患者将产生足够的统计力来确定组间的差异。基于改良的治疗意向（mITT）分析，三组将在治疗开始后4周进行比较。主要疗效测量是哮喘控制测试（ACT）评分从基线到治疗后4周的平均变化。次要结局包括1秒用力呼气量（FEV1）、用力肺活量（FVC）、呼气峰流量（PEF）和哮喘加重。该试验还分析了气道微生物组与哮喘治疗之间的关系。本研究采用随机临床试验设计。该结果基于几个结果，这些结果估计了JWYH配方的有效性以及气道微生物组与哮喘治疗之间的前瞻性联系。ClinicalTrials.gov, ID: NCT03299322。于2017年10月3日注册。本文的在线版本（10.1186/s13063-018-2739-8）包含补充内容，仅供授权用户使用。
Over the past two or three decades, the prevalence of asthma has significantly increased worldwide; therefore, effective treatment without side effects is of utmost importance. Traditional Chinese medicine (TCM) plays a vital role in reducing symptoms and improving the quality of life in persistent-asthma patients. The aim of this study is to evaluate the efficacy of the Jia Wei Yang He (JWYH) formula in the treatment of asthma and to explore the relationship between the airway microbiome and TCM treatment in asthma patients. This multicenter, parallel-arm, randomized, double-blinded, placebo-controlled trial will assess the efficacy of JWYH in asthma patients with usual care. Persistent-asthma patients without life-threatening disease will be enrolled on a random basis and are equally assigned to a high- or a low-dose JWYH plus usual care group, or a placebo plus usual care group. Patients are followed up for 4 months. Accordingly, 240 patients will yield sufficient statistical power to determine a difference between groups. Based on modified intent-to-treat (mITT) analyses, the three groups will be compared at 4 weeks after the beginning of treatment. The primary efficacy measurement is the mean change in the Asthma Control Test (ACT) score from baseline to 4 weeks post treatment. Secondary outcomes include forced expiratory volume in 1 s (FEV1), forced vital capacity (FVC), peak expiratory flow (PEF), and asthma exacerbations. This trial also includes analyses of the associations between airway microbiome and asthma treatment. In this study, a randomized clinical trial design is described. The results are based on several outcomes that estimate the efficacy of the JWYH formula and prospective links between the airway microbiome and asthma treatment. ClinicalTrials.gov, ID: NCT03299322. Registered on 3 October 2017. The online version of this article (10.1186/s13063-018-2739-8) contains supplementary material, which is available to authorized users.
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影响因子：
14.2
作者：
Marri, Pradeep Reddy;Stern, Debra A.;Wright, Anne L.;Billheimer, Dean;Martinez, Fernando D.
通讯作者：
Martinez, Fernando D.
DOI：
10.1016/j.jaci.2010.10.048
发表时间：
2011-02
期刊：
The Journal of allergy and clinical immunology
影响因子：
--
作者：
Huang YJ;Nelson CE;Brodie EL;Desantis TZ;Baek MS;Liu J;Woyke T;Allgaier M;Bristow J;Wiener-Kronish JP;Sutherland ER;King TS;Icitovic N;Martin RJ;Calhoun WJ;Castro M;Denlinger LC;Dimango E;Kraft M;Peters SP;Wasserman SI;Wechsler ME;Boushey HA;Lynch SV;National Heart, Lung, and Blood Institute's Asthma Clinical Research Network
通讯作者：
National Heart, Lung, and Blood Institute's Asthma Clinical Research Network
DOI：
10.1164/rccm.200406-710st
发表时间：
2005-04-15
影响因子：
24.7
作者：
American Thoracic Society;European Respiratory Society
通讯作者：
European Respiratory Society
影响因子：
14.2
作者：
Lemanske, RF
通讯作者：
Lemanske, RF
影响因子：
64.5
作者：
Goodrich JK;Di Rienzi SC;Poole AC;Koren O;Walters WA;Caporaso JG;Knight R;Ley RE
通讯作者：
Ley RE