Study on the Mechanism of Yifei Moxibustion in Enhancing Immune Function in Chronic Obstructive Pulmonary Disease Based on Plasma Exosomal miRNAs
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The level of plasma exosomal miR-125b
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Yifei moxibustion group
The patients in the Yifei Moxibustion group are treated with conventional Western medicine combined with Yifei Moxibustion.
干预措施: Yifei moxibustion (Behavioral)
Conventional Western medicine treatment group
The patients in the conventional Western medicine treatment group receives standard Western medication therapy.
干预措施: Conventional Western medicine treatment (Drug)
TCM syndrome differentiation treatment group
Patients in the TCM syndrome differentiation treatment group receives TCM pattern-based therapy in addition to conventional Western medical treatment.
干预措施: TCM syndrome differentiation treatment (Drug)
结局指标
主要结局
The level of plasma exosomal miR-125b
时间窗: Before treatment and 3 months after treatment
The regulatory effect of Yifei moxibustion on miR-125b was evaluated through the detection of peripheral venous blood.
T-cell subsets and immunoglobulin levels
时间窗: Before treatment and 3 months after treatment
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.
次要结局
- Clinical Symptoms and Signs Assessment Questionnaire Assessment(Before treatment, the first month, the second month and the third month)
- The modified Medical Research Council (mMRC) scale(Before treatment, the first month, the second month and the third month)
- Six-Minute Walk Distance（6MWD）(Before treatment, the first month, the second month and the third month)
- lung function(Time Frame：Before treatment and 3 months after treatment)
- The COPD Assessment Test (CAT)(Before treatment, the first month, the second month and the third month)
- The modified COPD Patient-Reported Outcome scale (mCOPD-PRO)(Before treatment, the first month, the second month and the third month.)
- The modified Effectiveness Satisfaction Questionnaire for COPD(Before treatment, the first month, the second month and the third month)
- Acute exacerbation situation(Before treatment, the first month, the second month and the third month)
- Adverse Event Documentation and Laboratory Safety Metrics(Before treatment and 3 months after treatment)