Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.
Respiratory Department, Beijing University of Chinese Medicine Affiliated Dongzhimen Hospital, Beijing, China.
BMJ Open. 2023 Sep 29;13(9):e070864. doi: 10.1136/bmjopen-2022-070864.
Chronic obstructive pulmonary disease (COPD) represents one of the leading causes of death worldwide. Published clinical trials suggest that the Chinese patent herbal medicine Shufeng Jiedu capsule (SFJD) is safe and may be effective for treating acute exacerbations of COPD (AECOPD). However, these effects have been reported with low or very low certainty evidence. This trial aims to evaluate the effectiveness and safety of SFJD for AECOPD.
This study is designed as a multicentre, randomised, double-blind, placebo-controlled trial. Three hundred patients with moderate or severe hospitalised AECOPD will be recruited in Beijing, Shanghai and Hefei. Participants will be randomly assigned to SFJD and usual care or placebo and usual care at a ratio of 1:1. SFJD and placebo will be administered orally four capsules three times daily for 7 consecutive days followed by an 8-week follow-up period. The primary outcome will be COPD symptom severity as measured by the EXAcerbation of Chronic Pulmonary Disease Tool score. Secondary outcomes include clinical symptoms, quality of life, length of hospital stay, a total dose of antibiotics, the frequency of recurrence of AECOPD, haematological biomarkers, death and adverse events. This study will answer the question of whether SFJD was safe to use and will improve symptoms in people with AECOPD, and will therefore reduce the necessity for antibiotics, the risk and duration of admission to hospital, and the risk of recurrence.
The ethics committee of the first affiliated hospital of Anhui Medical University, Beijing University of Chinese Medicine affiliated Dongzhimen hospital and fifth people's hospital of Shanghai Fudan University approved the study protocol. Informed written consent will be obtained from all the participants. The results of this trial will be disseminated at academic conferences and in peer-reviewed publications.
ISRCTN99049821.
慢性阻塞性肺疾病（COPD）是全球主要死亡原因之一。已发表的临床试验表明，中药疏风解毒胶囊（SFJD）安全且可能对治疗 COPD 急性加重（AECOPD）有效。然而，这些效果的证据质量为低或极低。本试验旨在评估 SFJD 治疗 AECOPD 的有效性和安全性。
本研究设计为多中心、随机、双盲、安慰剂对照试验。将在北京、上海和合肥招募 300 名中重度住院 AECOPD 患者。参与者将按 1:1 的比例随机分配至 SFJD 和常规治疗或安慰剂和常规治疗。SFJD 和安慰剂将口服，每日 3 次，每次 4 粒，连续 7 天，随后进行 8 周的随访期。主要结局将通过慢性阻塞性肺病恶化工具评分（EXAcerbation of Chronic Pulmonary Disease Tool score）评估 COPD 症状严重程度。次要结局包括临床症状、生活质量、住院时间、抗生素总剂量、AECOPD 复发频率、血液生物标志物、死亡和不良事件。本研究将回答 SFJD 是否安全使用以及是否能改善 AECOPD 患者的症状，从而减少抗生素的必要性、住院风险和时间以及复发风险的问题。
安徽医科大学第一附属医院、北京中医药大学东直门医院和上海复旦大学第五人民医院的伦理委员会批准了该研究方案。将从所有参与者处获得知情书面同意。本试验的结果将在学术会议和同行评议出版物上发表。
ISRCTN99049821。
