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

Henan University of Traditional Chinese Medicine

Status: Enrolling

Conditions: Stable COPD Patients

Treatments: Drug: Conventional Western medicine treatment; Drug: TCM syndrome differentiation treatment; Behavioral: Yifei moxibustion

Study type: Interventional

Funder types: Other

Identifiers

NCT07131020

Yifei moxibustion for COPD

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

Yifei moxibustion group

Experimental group

Description:

The patients in the Yifei Moxibustion group are treated with conventional Western medicine combined with Yifei Moxibustion.

Treatment:

Behavioral: Yifei moxibustion

Conventional Western medicine treatment group

Active Comparator group

Description:

The patients in the conventional Western medicine treatment group receives standard Western medication therapy.

Treatment:

Drug: Conventional Western medicine treatment

TCM syndrome differentiation treatment group

Active Comparator group

Description:

Patients in the TCM syndrome differentiation treatment group receives TCM pattern-based therapy in addition to conventional Western medical treatment.

Treatment:

Drug: TCM syndrome differentiation treatment