益肺灸治疗哮喘急性加重期：随机对照试验研究方案

IF 1.7 4区医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE

European Journal of Integrative Medicine Pub Date : 2025-09-12 DOI:10.1016/j.eujim.2025.102552

Jiaxin Xu , Peng Zhang , Jianya Yang , Yang Xie , Donghui Huang , Cuiling Feng , Suyun Li

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引用次数: 0

摘要

哮喘是全球最常见的慢性呼吸系统疾病之一，严重影响患者的生活质量。益肺灸是一种以督经（督经）为穴位，以草药隔灸为主的外治法。通过广泛的临床应用，益肺灸在治疗慢性气道疾病方面已显示出治疗潜力，但由于缺乏严格对照、高质量的随机临床试验，其治疗哮喘的疗效仍未得到充分验证。本研究旨在系统评价益肺灸治疗哮喘的临床疗效和安全性，并初步探讨其与免疫调节的相关性。方法：这是一项多中心、开放标签、随机对照试验。将384例控制不良哮喘患者按1:1的比例随机分为益肺艾灸组和常规护理对照组。益肺灸每10天进行一次，每次90分钟，从三伏日前10天开始。每年包括5次治疗，总共治疗2年。主要结局指标是急性加重的频率。次要结局包括哮喘控制测试（ACT）、哮喘控制问卷（ACQ）和哮喘生活质量问卷（AQLQ）得分。在治疗前、治疗后以及随访期间每13周对上述所有结果进行评估。肺功能和呼出一氧化氮分数（FeNO）测量将在基线、52周和104周进行。实验室血液生化分析将在基线、7周、52周、59周和104周进行。在每个疗程和随访期间对益肺艾灸不良事件进行评估。结论本试验将评价益肺艾灸治疗急性哮喘发作的疗效和安全性，并初步探讨其与免疫调节的相关性，为哮喘治疗提供临床参考。临床试验注册：临床试验网站NCT 06777472。于2025年1月10日注册。

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Yifei moxibustion treatment for acute exacerbations of asthma: study protocol for a randomized controlled trial

Introduction

Asthma is one of the most prevalent global chronic respiratory diseases and significantly impairs patients' quality of life. Yifei moxibustion is an external therapy that involves herb-partitioned moxibustion along the Governor Channel (Du Meridian). While Yifei moxibustion has demonstrated therapeutic potential in managing chronic airway disease through extensive clinical application, its efficacy in asthma treatment remains insufficiently validated, due to the absence of rigorously controlled, high-quality randomized clinical trials. This study aims to systematically evaluate the clinical efficacy and safety of Yifei moxibustion in asthma management while preliminarily investigating its correlation with immune regulation.

Methods

This is a multicenter, open-label, randomized controlled trial. A total of 384 participants with poorly controlled asthma will be randomly allocated to the Yifei moxibustion group and the usual care control group at a 1:1 ratio. The Yifei moxibustion consists of 90-minute sessions every 10 days, starting 10 days before the first Sanfu day. Each year includes 5 treatment sessions, for a total of 2 years of treatment. The primary outcome measure is the frequency of acute exacerbations. Secondary outcomes comprise Asthma Control Test (ACT), Asthma Control Questionnaire (ACQ), and Asthma Quality of Life Questionnaire (AQLQ) scores. All the above outcomes will be assessed before treatment, after treatment, and every 13 weeks during the follow-up period. Pulmonary function and fractional exhaled nitric oxide (FeNO) measurements will be conducted at baseline, 52 weeks, and 104 weeks. Laboratory blood biochemical analysis will be carried out at baseline, 7, 52, 59 and 104 weeks. The adverse events of the Yifei moxibustion will be evaluated at each treatment session and follow-up period.

Conclusion

This trial will evaluate the efficacy and safety of Yifei moxibustion in managing acute asthma exacerbations while preliminarily investigating its correlation with immune regulation, providing clinical references for asthma treatment.

Trial registration

Clinical Trials.gov NCT 06777472. Registered on 10 January 2025.

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来源期刊

European Journal of Integrative Medicine INTEGRATIVE & COMPLEMENTARY MEDICINE-

CiteScore

4.70

自引率

4.00%

发文量

102

审稿时长

33 days

期刊介绍： The European Journal of Integrative Medicine (EuJIM) considers manuscripts from a wide range of complementary and integrative health care disciplines, with a particular focus on whole systems approaches, public health, self management and traditional medical systems. The journal strives to connect conventional medicine and evidence based complementary medicine. We encourage submissions reporting research with relevance for integrative clinical practice and interprofessional education. EuJIM aims to be of interest to both conventional and integrative audiences, including healthcare practitioners, researchers, health care organisations, educationalists, and all those who seek objective and critical information on integrative medicine. To achieve this aim EuJIM provides an innovative international and interdisciplinary platform linking researchers and clinicians. The journal focuses primarily on original research articles including systematic reviews, randomized controlled trials, other clinical studies, qualitative, observational and epidemiological studies. In addition we welcome short reviews, opinion articles and contributions relating to health services and policy, health economics and psychology.