Study on the Mechanism of Yifei Moxibustion Improving Immune Function in COPD Based on Plasma Exosome miRNAs

Henan University of Traditional Chinese Medicine120 enrolled

Overview

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.

Chronic obstructive pulmonary disease (COPD) is the most common chronic airway disease, and airway inflammation and immune regulation mechanisms play a significant role in its development. Macrophage polarization is involved in the immune response process of COPD and is crucial for the resolution of airway inflammation and the regulation of the body's immune system. Among them, M1 polarization of macrophages can expand the inflammatory response, cause tissue damage, and aggravate the disease progression. Literature indicates that exosomal miR-125b may be an important target for regulating M1 polarization of macrophages.Yifei Moxibustion can improve the immune function of COPD patients, but its mechanism of action is still unclear. Therefore, the following hypothesis is proposed: Yifei Moxibustion can promote the resolution of inflammation and regulate the body's immune system by regulating miR-125b-mediated M1 polarization of macrophages. This study adopts a randomized controlled design, including 90 patients and 30 healthy volunteers. Patients are randomly divided into the Yifei Moxibustion group, the Western medicine conventional treatment group, and the TCM syndrome differentiation treatment group, and treated for 3 months. Peripheral venous blood is collected from healthy volunteers and patients. Firstly, T cell subsets, immunoglobulins and other indicators are observed to evaluate the effect of Yifei Moxibustion on improving immune function. Secondly, macrophage polarization is detected by nanoparticle tracking analysis, co-culture of transfected cells, CCK8 and other methods. miR-125b differentially expressed target genes are screened by miRDB and other databases, and the secretion of target genes regulated by exosomes is verified by luciferase reporter gene and other methods. Finally, macrophage polarization-related markers of patients before and after intervention are detected by flow cytometry, ELISA and other methods to preliminarily verify the regulation of exosomes on target genes, as well as potential targets and molecular mechanisms.

Interventions

Yifei moxibustionBEHAVIORAL

The 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 treatmentDRUG

TCM syndrome differentiation treatmentDRUG

The 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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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; * Patients known to be allergic to the ingredients of the moxibustion powder.

Outcomes

Primary Outcomes

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.

Time frame: Before treatment and 3 months after treatment

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.

Time frame: Before treatment and 3 months after treatment

Secondary Outcomes

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.