To observe the effects of fastigial nucleus stimulation on serum inflammation, oxidative stress related factors, cardiac autonomic function and prognosis in patients with coronary heart disease
In recent years, with the improvement of the material living standards of the investigators residents and the change of working lifestyle, the prevalence and mortality of coronary heart disease (CHD) in urban and rural residents in China have increased year by year. According to statistics, the number of patients with coronary heart disease in China is currently 11 million. Coronary heart disease has become a major health problem in China. At present, it is found that inflammatory reaction and oxidative stress factors are involved in the occurrence and development of coronary heart disease, and their indicators such as heart rate variability are related to the prognosis of coronary heart disease. Fastigial nucleus stimulation (FNS) has been widely used in the treatment of various diseases such as cerebrovascular disease, migraine, and eye diseases. The study found that FNS can reduce inflammatory cytokines and oxidative stress factors in ischemic myocardium and improve heart rate variability in rats with myocardial infarction. The aim of this study was to investigate whether FNS can improve the aforementioned indicators and clinical outcomes in patients with coronary heart disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
200
Select mode 3, frequency 136, intensity below 90, ratio 1.0-2.0, based on the patient's no discomfort. The main pole is attached to the bilateral mastoid, and the auxiliary pole is attached to the bilateral internal cave. Non-invasive introduction of bio-electricity into the cerebellar nucleus for stimulation
Refer to the "Guidelines for Rational Use of Coronary Heart Diseases".rational selection of antiplatelet drugs, statins, etc. according to the patient's condition
The Third Hospital of Mianyang
Mianyang, Sichuan, China
Observe the changes of serum IL-6 after treatment.
Observe the changes of serum IL-6 levels（pg/ml）after treatment in the two groups of patients.
Time frame: baseline,1month
Observe the changes of serum hs-CRP after treatment.
Observe the changes of serum hs-CRP levels（mg/l）after treatment in the two groups of patients.
Time frame: baseline,1month
Observe the changes of serum TNF-α after treatment.
Observe the changes of serum TNF-α levels（pg/ml）after treatment in the two groups of patients.
Time frame: baseline,1month
Observe the changes of serum Lp-PLA2 after treatment.
Observe the changes of serum Lp-PLA2 levels（ng/ml）after treatment in the two groups of patients.
Time frame: baseline,1month
Observe the changes of serum SOD（Superoxide dismutase） after treatment.
Observe the changes of serum SOD levels（ng/ml）after treatment in the two groups of patients.
Time frame: baseline,1month
Observe the changes of serum GPX（Glutathione peroxidase） after treatment.
Observe the changes of serum GPX levels（ng/ml）after treatment in the two groups of patients.
Time frame: baseline,1month
Observe the changes of serum MDA（Malondialdehyde） after treatment.
Observe the changes of serum MDA levels（nmol/ml）after treatment in the two groups of patients.
Time frame: baseline,1month
Observe the changes of serum AOPP（Advanced oxidation protein product） after treatment.
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Observe the changes of serum AOPP levels（umol/l）after treatment in the two groups of patients.
Time frame: baseline,1month
Observe the changes of SDNN（Standard Deviation of the NN intervals） after treatment.
Observe the changes of SDNN（ms）after treatment in the two groups of patients.
Time frame: baseline,1month
Observe the changes of SDANN（Standard Deviation of mean NN intervals in 5-minute recordings） after treatment.
Observe the changes of SDANN（ms）after treatment in the two groups of patients.
Time frame: baseline,1month
Observe the changes of SDNN In（Average of the standard deviation of the NN interval every 5 minutes） after treatment.
Observe the changes of SDNN In（ms）after treatment in the two groups of patients.
Time frame: baseline,1month
Observe the changes of rMSSD（square root of the mean squared differences of successive NN intervals） after treatment.
Observe the changes of rMSSD（ms）after treatment in the two groups of patients.
Time frame: baseline,1month
Observe the changes of pNN50（Percentage of the difference between adjacent RR intervals >50ms ） after treatment.
Observe the changes of pNN50（%）after treatment in the two groups of patients.
Time frame: baseline,1month
Follow-up rate of major cardiovascular events
The improvement of symptoms and the in-stent restenosis, myocardial infarction, readmission due to heart failure, and mortality were observed in the two groups after 12 months of discharge.
Time frame: 12months