Department of Graduate School, Beijing University of Chinese Medicine, Beijing, China.
Department of TCM Pulmonary Diseases, Center of Respiratory Medicine, China-Japan Friendship Hospital; National Clinical Research Center for Respiratory Diseases, Beijing, China
BMJ Open. 2019 Nov 28;9(11):e030249. doi: 10.1136/bmjopen-2019-030249.
Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) brings a serious impact on patients' quality of life, and has extremely high morbidity and mortality worldwide. Although there are many therapies being developed to alleviate symptoms and reduce mortality, a few studies have supported which treatment method is the best. Traditional Chinese medicine (TCM) has shown good potential in the prevention and treatment of AECOPD, especially in terms of supplementation and reduction of dosage and adverse effect of Western medicine. The purpose of this study is to compare the effectiveness of combination of TCM and Western medicine with conventional therapy alone for AECOPD, and to ensure whether the combined therapy may reduce the use of systemic glucocorticoid in AECOPD without influencing efficacy.
A multicentre, randomised, double-blind, placebo-controlled study was conducted to enrol a total of 360 eligible patients who will be randomised into integrated Chinese and Western medicine group A, B and Western standard Medicine group C. After 5 days of intervention and 1 month of follow-up, the efficacy and safety of Xin Jia Xuan Bai Cheng Qi Decoction in patients with AECOPD will be observed. The results of evaluation indicators include: clinical symptoms, biochemical indicators such as blood gas analysis, inflammatory markers, hospitalisation time, TCM syndrome evaluation, biological indicators such as airway, intestinal flora sequencing.
This trail has been approved by the Ethics Committee of China-Japan Friendship Hospital. The results will be disseminated in international peer-reviewed journals and be presented in academic conferences. The results will also be disseminated to patients by telephone, inquiring on patient's poststudy health status during the follow-up.
ChiCTR1800016915.
慢性阻塞性肺疾病（COPD）急性加重（AECOPD）给患者的生活质量带来严重影响，在全球范围内具有极高的发病率和死亡率。尽管有许多治疗方法被开发出来以缓解症状和降低死亡率，但很少有研究支持哪种治疗方法是最好的。中药（TCM）在预防和治疗 AECOPD 方面显示出良好的潜力，特别是在西药的补充、减少剂量和不良反应方面。本研究旨在比较 TCM 与西药联合治疗与单纯常规治疗对 AECOPD 的疗效，以确保联合治疗是否可以在不影响疗效的情况下减少 AECOPD 中全身糖皮质激素的使用。
采用多中心、随机、双盲、安慰剂对照研究，共纳入 360 例符合条件的患者，将其随机分为中药联合治疗组 A、B 和西药标准治疗组 C。干预 5 天后和随访 1 个月后，观察新甲宣白承气汤治疗 AECOPD 患者的疗效和安全性。评估指标的结果包括：临床症状、血气分析等生化指标、炎症标志物、住院时间、中医证候评价、气道等生物学指标、肠道菌群测序。
该试验已获得中日友好医院伦理委员会的批准。研究结果将在国际同行评议期刊上发表，并在学术会议上展示。研究结果还将通过电话向患者传播，在随访期间询问患者的研究后健康状况。
ChiCTR1800016915。
