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

Официальное название

Study on the Mechanism of Yifei Moxibustion in Enhancing Immune Function in Chronic Obstructive Pulmonary Disease Based on Plasma Exosomal miRNAs

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Yifei moxibustion
  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 sprinklin
• Препарат Conventional Western medicine treatment
  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.
• Препарат TCM syndrome differentiation treatment
  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 Associat

Первичные конечные точки

• The level of plasma exosomal miR-125b [Срок оценки: Before treatment and 3 months after treatment]
• T-cell subsets and immunoglobulin levels [Срок оценки: Before treatment and 3 months after treatment]

Вторичные конечные точки (9)

• Clinical Symptoms and Signs Assessment Questionnaire Assessment [Срок оценки: Before treatment, the first month, the second month and the third month]
• The modified Medical Research Council (mMRC) scale [Срок оценки: Before treatment, the first month, the second month and the third month]
• lung function [Срок оценки: Time Frame：Before treatment and 3 months after treatment]
• Six-Minute Walk Distance（6MWD） [Срок оценки: Before treatment, the first month, the second month and the third month]
• The COPD Assessment Test (CAT) [Срок оценки: Before treatment, the first month, the second month and the third month]
• The modified COPD Patient-Reported Outcome scale (mCOPD-PRO) [Срок оценки: Before treatment, the first month, the second month and the third month.]
• The modified Effectiveness Satisfaction Questionnaire for COPD [Срок оценки: Before treatment, the first month, the second month and the third month]
• Acute exacerbation situation [Срок оценки: Before treatment, the first month, the second month and the third month]
• Adverse Event Documentation and Laboratory Safety Metrics [Срок оценки: Before treatment and 3 months after treatment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• the First Affiliated Hospital of Henan University of Chinese Medicine — Чжэнчжоу

Идентификаторы

NCT: NCT07131020 · Yifei moxibustion for COPD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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