Study On The Efficacy And Side Effects Of The Red Yeast Products On Hyperlipidemia

Background and objective :Atherosclerosis is of the most common and important one in arteriosclerotic vascular diseases.They share a common feature that the arterial wall get thicken and harden,lose elasticity and the lunmen of arterial get narrow.The whole pathological changes are complicated with the participation of a variety of diseases,including the accumulation of partial lipid and complex carbohydrate,the proliferation of fibrous tissue,the formation of calcification plaque,and the secondary plaque hemorrhage,rupture,thrombosis.The risk of atherosclerosis varies according to the position it take place and the degree of stenosis.It could cause serious consequence even the death of patients if atherosclerosis occurs in the coronary artery.This kind of disease is defined as coronary artery disease(CAD)or coronary heart disease(CHD)and it has been the main cause that could lead to death and disability in developed countries.Although the death rate caused by coronary heart disease has declined in recent forty years worldwide,there are still one third patients died from coronary heart disease.And thus the prevention and treatment for coronary heart disease should be given enough attention.Among the various risk factors,Dyslipidemia is rather common and important.A good serum lipid level can slow down the process of CHD,and improve the life quality of patients.Recently,the wide use of the medicine Atorvastatin and other statins slow down the progress of acute myocardial infarctions,and avoid the bleeding,thrombosis risk caused by the treatment percutaneous coronary intervention(PCI).But the benefits are accompanied by the risk,these medicine could bring side effects like elevation of liver enzymes and gastrointestinal reactions.Large-scale clinical studies have shown that the incidence of myalgia caused by use of statins rise to 10% to 15%,in some people rhabdomyolysis could happen.In order to avoid the occurrence of these side effect,some feasible method could be done—early use of lower dose medicine in order to prevent coronary heart disease.But there is few researches related to the issue.At present,there are a large number of studies to analyze the efficacy and side effects of the Red Yeast extract,but limited to specific drugs(Xuezhikang)and confined to the level of treatment of Hyperlipidemia,little research in the prevention level.In this article,an important risk factor for coronary heart disease,dyslipidemia,was used to study the efficacy and side effects of the Red Yeast extraction drug(Xuezhikang)and the Red Yeast suspension on blood lipid abnormality in rats.So we could speculate efficacy and safety in preventing or treating human hyperlipidemia using red yeast and its by-products.Method1.30 patients with primary hyperlipidemia who were enrolled in the Department of Cardiology,the First Affiliated Hospital of Anhui Medical University from June 2015 to June 2016 were selected as the study subjects.The diagnostic criteria for hyperlipidemia should follow the prevention and treatment of hyperlipidemia in Chinese adults 2007.Before starting this research,we ask the patients to stop taking some other pills that could affect the level of blood lipid and test their blood lipid several days later.During the treatment,the patients take Xuezhikang(produced by Beijing Peking University WBL Biotech Co.,Ltd)1.2gram per time,twice a day(morning and evening).The patients should also stay a regular diet,keep a record of side effects and follow up to the doctors in two months.Then they will be asked to test the blood lipid again in order to evaluate if there are changes after the treatment so we could assess the efficacy and safety of the drug Xuzhikang.2.50 strong and active SD rats provided by experimental center of Anhui Medical University are selected and divided randomly into 5 groups(n = 10),group A(normal control group),group B(the Red Yeast lower-dose prevention group,0.1mg/kg),group C(the Red Yeast higher-dose prevention group,0.4mg/kg),group D(statin treatment group,0.1mg / kg),group E(the Red yeast treatment group,0.4mg / kg).All groups will be fed with high-fat diet except group A.Group B and Group C will be given the corresponding dose of Red Yeast suspension additionally.During the course of the experiment,blood lipid levels will be monitored regularly and weight gain are recorded.By comparing the normal model group and the Red Yeast prevention group,we can understand the protective effect of Monascus and its metabolites on the changes of blood lipid in rats.After the establishment of hyperlipidemia,we will compare the group D and the group E on to study the effect of Monascus on hyperlipidemia in rats.Based on the level of blood lipid,the change of body weight and the number of deaths,the curative effect and side effect of red yeast on hyperlipidemia were evaluated comprehensively.Result1.Clinical research30 cases of primary hyperlipidemia patients who were asked to take Xuezhikang and follow up to the doctors had been test the blood lipid,the results suggested that after the two-month treatment,the patients' lipid TC,TG,LDL-c had been lowered and lipid HDL-c had been elevated and the levels before and after treatment were significantly different(P<0.05).No adverse reactions were reported in all these 30 patients.2.Animals experiment2.1 In the study of the effects on the different doses of red yeast on hyperlipidemia rats,we used the SPSS software to handle the statistics figures of rats' from group A,B,and C,and we come to a conclusion that different doses of the red yeast exert different effects on hyperlipidemia rats,and the discrepancy between the three groups were statistically significant.(P<0.05).The higher-dose prevention group had a better preventive efficacy on hyperlipidemia rats.During the six weeks experiment period,no rat died in group A,2 rats died in group B and 3 rats in group C died.2.2 In the comparison of atorvastatin and Monascus on the efficacy in hyperlipidemia experient,the difference between the group D and the group E was statistically significant(P < 0.05),0.4mg/kg dose of Monascus suspension can significantly reduce the blood lipid level of hyperlipidemia rats,and its efficacy is better than 0.1mg/kg dose of atorvastatin.Conclusion1.In the clinical study,Xuezhikang can effectively reduce the total cholesterol,triglyceride and low density lipoprotein cholesterol levels in patients with hyperlipidemia,significantly increased the level of high density lipoprotein,and compared with statins,Xuezhikang has fewer side effects.2.Red yeast products can delay the formation of hyperlipidemia in rats.3.0.4mg / kg of red yeast can treat rat hyperlipidemia,the effect is better than 0.1mg / kg atorvastatin.