使用中药治疗慢性阻塞性肺疾病急性加重以减少抗生素使用（EXCALIBUR）：一项随机双盲、安慰剂对照可行性试验的研究方案
Treating Acute EXacerbations of COPD with Chinese HerbAL MedIcine to aid AntiBiotic Use Reduction (EXCALIBUR): study protocol of a randomised double-blind, placebo-controlled feasibility trial.
作者信息
Hu Xiao-Yang, Oliver Tom, Willcox Merlin, Simpson Catherine, Thorne Kerensa, Trill Jeanne, Francis Nick, Stuart Beth, Thomas Michael, Little Paul, Liu Jian-Ping, Griffiths Gareth, Moore Michael
机构信息
Primary Care, Population Science and Medical Education, Faculty of Medicine, University of Southampton, Southampton, UK.
Southampton Clinical Trial Unit, University of Southampton, Southampton, UK.
出版信息
Pilot Feasibility Stud. 2022 Dec 19;8(1):262. doi: 10.1186/s40814-022-01224-8.
BACKGROUND
Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) are a major reason for consultations in primary care, hospital admissions, deterioration in function, and mortality. Despite the majority of exacerbations not being caused by bacteria, as many as 70% of patients who present in UK primary care with AECOPD are prescribed antibiotics as part of standard care. However, finding effective non-antibiotic treatments for COPD exacerbations is a priority to reduce antibiotic use. The Chinese herbal medicine Shufeng Jiedu® (SFJD) has the potential to reduce treatment failure and duration of hospital stay. This study aims to determine the feasibility of conducting a fully powered randomised, double blind, placebo-controlled clinical trial on SFJD for AECOPD in UK primary care.
METHODS
This study is a phase III, two-arm individually double blind, randomised, placebo-controlled feasibility trial with nested qualitative study, coordinated by the Southampton Clinical Trial Unit (SCTU). Patients aged ≥ 40 years, with a current AECOPD, presenting with increased sputum purulence/volume, or breathlessness, and for whom the GP is considering use of antibiotics, will be eligible to participate. We aim to recruit seven eligible participants per month and randomise them to receive either the patent Chinese herbal medicine SFJD capsules or placebo for 14 consecutive days and to follow-up for 12 weeks. The primary outcomes include the feasibility of recruitment, study retention, and the percentage of diary completion.
DISCUSSION
If this trial demonstrates the feasibility of recruitment, delivery, and follow-up, we will seek funding for a fully powered placebo-controlled trial of SFJD for the treatment of AECOPD in primary care.
TRIAL REGISTRATION
This trial is registered via ISRCTN on 1 July 2021, identifier: ISRCTN26614726.
背景
慢性阻塞性肺疾病急性加重（AECOPD）是基层医疗咨询、住院、功能恶化及死亡的主要原因。尽管大多数加重并非由细菌引起，但在英国基层医疗中因AECOPD就诊的患者中，多达70%会接受抗生素治疗作为标准治疗的一部分。然而，寻找有效的非抗生素治疗COPD加重是减少抗生素使用的首要任务。中药疏风解毒®（SFJD）有可能降低治疗失败率和缩短住院时间。本研究旨在确定在英国基层医疗中对AECOPD患者开展一项关于SFJD的充分样本量的随机、双盲、安慰剂对照临床试验的可行性。
方法
本研究是一项由南安普顿临床试验单位（SCTU）协调的III期、双臂个体双盲、随机、安慰剂对照可行性试验，并嵌套定性研究。年龄≥40岁、目前患有AECOPD、出现痰液脓性/量增加或呼吸困难且全科医生正在考虑使用抗生素的患者将有资格参与。我们的目标是每月招募7名符合条件的参与者，将他们随机分组，连续14天接受专利中药SFJD胶囊或安慰剂治疗，并随访12周。主要结局包括招募的可行性、研究保留率以及日记完成率。
讨论
如果本试验证明招募、实施和随访的可行性，我们将寻求资金开展一项关于SFJD治疗基层医疗中AECOPD的充分样本量的安慰剂对照试验。
试验注册
本试验于2021年7月1日通过ISRCTN注册，标识符：ISRCTN26614726。
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