This study adopted a randomized controlled design, enrolling 90 patients and 30 healthy volunteers. The patients were randomly divided into the Yifei Moxibustion group, the conventional Western medicine treatment group, and the TCM syndrome differentiation treatment group, and were treated for 3 months. Peripheral venous blood was collected from both the healthy volunteers and the patients to observe indicators such as T cell subsets and immunoglobulins, to evaluate the effect of Yifei Moxibustion on improving immune function. The regulation of target genes by exosomes and potential action targets and molecular mechanisms were preliminarily verified through techniques such as nanoparticle tracking technology and flow cytometry.
Patients who meet the diagnostic criteria for stable chronic obstructive pulmonary disease;
Patients who meet the TCM diagnostic criteria for lung qi deficiency, lung-spleen qi deficiency, and lung-kidney qi deficiency; ③ Aged 18 to 80 years old; ④ Voluntarily signed the informed consent form.
Pregnant and lactating women;
Patients with cognitive impairment, confusion, dementia, or various mental disorders;
Patients with unstable angina pectoris or acute myocardial infarction;
Patients with a history of syncope after exercise or bone and joint diseases that affect exercise; ⑤ Patients with pneumothorax, pleural effusion, pulmonary embolism, or tumors;
Parallel
Yifei moxibustion
BehavioralThe conventional Western medicine treatment is based on the 2023 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and the 2021 Chinese Thoracic Society guidelines for the diagnosis and management of chronic obstructive pulmonary disease. Bronchodilators, inhaled corticosteroids, or a combination therapy are administered.The Yifei moxibustion is applied from the Dazhui to Yaoshu acupoints along the Governor Vessel. Ginger juice is spread over the treatment area, followed by sprinkling moxa powder and covering with mulberry bark paper. A 2.5 cm thick layer of ginger paste and a 3 cm thick layer of moxa wool are then placed on the mulberry bark paper. The moxa wool is ignited and allowed to burn out naturally, being replaced every 30 minutes. After 90 minutes, the ginger paste is removed. The treatment is performed once every 15 days, with 6 sessions constituting one course of treatment, totaling 3 months.
Conventional Western medicine treatment
DrugThe conventional Western medicine treatment is based on the 2023 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and the 2021 Chinese Thoracic Society guidelines for the diagnosis and management of chronic obstructive pulmonary disease. Bronchodilators, inhaled corticosteroids, or a combination therapy are administered.
TCM syndrome differentiation treatment
DrugThe conventional Western medicine treatment followes the same protocol as described above. The diagnosis of TCM pattern-based therapy is made in accordance with the TCM Syndrome Diagnostic Criteria for Chronic Obstructive Pulmonary Disease issued by the Pulmonary Disease Committee of the Internal Medicine Branch, China Association of Chinese Medicine and the treatment is based on the 2019 Guidelines for Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease issued by the China Association of Chinese Medicine.
The level of plasma exosomal miR-125b
The regulatory effect of Yifei moxibustion on miR-125b was evaluated through the detection of peripheral venous blood.
T-cell subsets and immunoglobulin levels
By detectingCD3+、CD4+、CD8+、CD4+/CD8+、Th17、Treg、Th17/Treg 、IgG、IgA、IgM, the regulatory effect of Yifei moxibustion on the immune function of COPD was evaluated.
Clinical Symptoms and Signs Assessment Questionnaire Assessment
Clinical Symptoms and Signs Assessment Questionnaire Assessment will be performed by clinical symptoms and signs questionnaire. The clinical symptoms to be evaluated in this study include cough, phlegm, chest tightness, gasp, shortness of breath, feeble and cyanosis. A score of 0-3 will be given to every symptom or sign with a higher score indicating a worse conditoin.
The modified Medical Research Council (mMRC) scale
The modified Medical Research Council (mMRC) scale is a 5-point (0-4) scale based on the severity of dyspnoea. "0" means no dyspnea perception, "4" means severe dyspnea perception.
lung function
Forced Vital Capacity (FVC)#Forced Expiratory Volume in One Second (FEV1) and Percentage of Forced Expiratory Volume in One Second to Predicted Value (FEV1% pred) were mainly used for lung function evaluation
Six-Minute Walk Distance（6MWD）
The six-minute walk distance is used to assess exercise tolerance and functional status.
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