| Dyslipidemia is a disorder in the production of lipoproteins in the human plasma.It is an abnormality in the body’s lipid metabolism that results in the overproduction or underproduction of some lipoproteins.A 2012 report on nutrition and chronic diseases in China showed that the prevalence of hypercholesterolemia among adults in China was 4.9%and the prevalence of hypertriglycerides was 13.1%,with the overall prevalence of dyslipidemia reaching 40.4%.Statins have made some progress in the treatment of dyslipidaemia as the first choice of clinical lipid-regulating drugs,but they still face many problems,such as the need for patients to adhere to the medication for a long time;some people experience increased liver enzymes,hepatotoxic symptoms,muscle pain and rhabdomyolysis after using statins,leading to psychological resistance or forced discontinuation of the medication.Chinese medicine has outstanding advantages in treating dyslipidaemia with precise efficacy and fewer side effects.The Vapor Therapy Lipid Regulation Method was gradually developed on the basis of folk therapies such as Yao bath,sweat steam,fumigation and medicinal bath.By using modern fumigation apparatus,combining medicine,water and heat,dampness and other pathological products are discharged with sweat through sweating,while using the opening and closing of the Xuan Fu to incorporate medicine and reach the place of illness,gradually forming a new method of vapor therapy to regulate dyslipidemia.A previous study by our group has shown that steam therapy can effectively reduce cholesterol,triglyceride and low-density lipoprotein levels in patients with dampness-paralyzed hyperlipidaemia,confirming that the steam therapy method is an effective treatment for dyslipidaemia.Objective:In this study,the clinical evaluation and mechanism of action of vapor therapy lipid regulating method for the treatment of dyslipidemia were carried out.The clinical evaluation study was conducted to evaluate the clinical efficacy and safety of vapor therapy lipid regulating method for the treatment of dyslipidemia,and to investigate the principle of action of vapor therapy lipid regulating method for the treatment of dyslipidemia,and the mechanism of action study was conducted to explore the mechanism of lipid metabolism of vapor therapy lipid regulating method for the treatment of dyslipidemia by LC-MS non-targeted metabolomics.Methods:1.This clinical trial adopted a multicenter,own before-and-after controlled study design,and included patients in 4 sub-centers of Guang’anmen Hospital of the Chinese Academy of Traditional Chinese Medicine,Qingdao City Hospital of Traditional Chinese Medicine,Linyi Central Hospital and Linyi City Hospital of Traditional Chinese Medicine.The treatment method was vapor therapy using the Dampness-Lowering Formula,and the treatment course was 8 weeks(2 times/week),each treatment time was 20 min,and the temperature of vapor therapy was 40-45℃.The efficacy indexes included TC,TG,LDL-C,HDL-C,atherosclerosis index(AI)and TCM syndrome score,etc.The safety indexes included skin status,electrolytes,ECG,blood routine,urine routine,CRP,liver function,kidney function,LDH,CK and CK-MB,etc.The clinical efficacy and safety of the vapor therapy lipid regulating method in the treatment of dyslipidemia were observed.2.This clinical trial was conducted in Guang’anmen Hospital of the Chinese Academy of Traditional Chinese Medicine using a single-centre,randomized,single-blind,placebo-controlled superiority study design.120 patients were enrolled,60 in the treatment group and 60 in the placebo group,and the treatment group was fumigated with the Dampness and Lipid Reduction Formula,while the placebo group was fumigated with plain water alone;the treatment course for both groups was 8 weeks(2 times/week),and the duration of each treatment was 20 min The baseline data(age,gender,BMI,heart rate,waist circumference,abdominal circumference,blood pressure,etc.)of the two groups before treatment were observed.The main efficacy indicators included TC,TG,LDL-C,HDL-C,secondary efficacy evaluation indicators included LP(a),ApoB,ApoA1,VLDL,TCM symptom score,etc.The safety indicators included skin status,The clinical efficacy and safety of Vapor Therapy Lipid Regulating Method in the treatment of dyslipidemia were evaluated,and the principle of action of Vapor Therapy Lipid Regulating Method and its key action links were explored.3.LC-MS non-targeted metabolomics was used to collect serum samples from patients included in the clinical randomized controlled trials,and serum samples from the vapor therapy lipid regulating group and the placebo group before and after treatment were tested and analyzed,and the differential metabolites were screened and identified using the criteria of P value<0.05 and VIP>1.KEGG analysis was performed to identify the potential metabolites and metabolic pathways of dyslipidemia in the vapor therapy lipid modulation group,and to explore the underlying mechanisms of dyslipidemia in the vapor therapy lipid modulation group.Results:1.A total of 152 patients with dyslipidemia were included in this trial,including 67 from Guang’anmen Hospital,14 from Qingdao Hospital of Traditional Chinese Medicine,52 from Linyi Central Hospital and 19 from Linyi Hospital of Traditional Chinese Medicine.The total effective rate after 8 weeks of vapor therapy lipid regulation therapy was 85.53%.The patients’ TC,LDL-C and TG levels decreased significantly after treatment,and there was a statistically significant difference in the comparison of TC,LDL-C and TG before and after treatment(P<0.01),the increase in HDL-C levels was not significant after treatment,and there was no statistically significant difference in the comparison of HDL-C before and after treatment(P>0.05),and the AI values significantly decreased,and the difference between AI before and after treatment was statistically significant(P<0.01).The effective rate of improvement of TCM symptom score by vapour therapy and lipid regulation was 92.76%,and there was a statistically significant difference in TCM symptom score between patients before and after treatment(P<0.01).During the treatment,no patient developed allergies,burns and other skin injuries,and only one patient had mild abnormalities of glutathione transaminase.No abnormalities were found in ECG,blood routine,urine routine,CRP,renal function,electrolytes,LDH,CK and CK-MB.2.A total of 120 patients with dyslipidemia were included in this trial,60 cases each in the treatment and placebo groups,including 20 shedding cases,including 10 cases each in the treatment and placebo groups,and 100 final effective cases.There was no significant difference(P>0.05)in the comparison of baseline information(age,gender,BMI,heart rate,waist circumference,abdominal circumference,blood pressure,etc.)between the treatment and placebo groups before treatment.After 8 weeks of treatment,the total effective rate was 86.00%in the treatment group and 52%in the placebo group,and the total lipid-lowering effective rate in the treatment group was better than that in the placebo group(P<0.01).TC and LDL-C levels decreased significantly in the treatment group after treatment,and the comparison before and after treatment showed that the difference in TC and LDL-C was statistically significant(P<0.01),and the treatment group was better than the placebo control group in reducing TC and LDL-C(P<0.01),and the comparison of the decrease in blood lipid indexes before and after treatment showed that the decrease in TC and LDL-C in the treatment group was more significant,and the The difference between the treatment group and the placebo group was statistically significant(P<0.01).ApoB levels decreased significantly in the treatment group,and the difference before and after treatment was statistically significant(P<0.01)and better than that in the placebo group(P<0.01).The total effective rate of improving TCM symptom score was 98.00%in the treatment group and 88.00%in the placebo group.The difference in the total effective rate of improving TCM symptom score between the treatment and placebo groups was not significant(P>0.05).The safety analysis of the treatment and placebo groups showed that no patient developed skin allergy,burns and other skin injuries,and no significant abnormalities were found in ECG,blood routine,urine routine,CRP,liver and kidney function,electrolytes,LDH,CK and CK-MB.3.LC-MS untargeted metabolomics results showed that 19 differential metabolites were screened before and after treatment in the treatment group.KEGG enrichment pathway analysis showed that the most influential metabolic pathways were mainly 3,Linoleic acid metabolism,Pantothenate and CoA biosynthesis(Pantothenate and CoA biosynthesis,Nicotinate and nicotinamide metabolism,the main metabolites involved are Linoleic acid,12,13-DHOME,L-Cysteine Ureidopropionic acid,Succinic acid semialdehyde and 6-Hydroxynicotinic acid,all of which are closely related to lipid metabolism.A total of 17 differential metabolites were screened before and after treatment in the placebo group,and KEGG enrichment pathway analysis revealed four main metabolic pathways that had the greatest impact after treatment in the placebo group,namely Intestinal immune network for IgA production,Small cell lung cancer,Th17 cell differentiation and Gastric cancer.The main metabolites involved are all-trans-Histamine,all-trans-Retinoic acid,12-Keto-tetrahydro-leukotriene B4,and these metabolic pathways did not correlate significantly with lipid metabolism.A comparison of the KEGG pathway analysis between the treatment group and the placebo group showed that the mechanism of action of vapor therapy lipid modulation was mainly related to the lipid metabolism pathway,and that the vapor therapy lipid modulation method interfered with lipid metabolism pathways such as linoleic acid metabolism,pantothenate and coenzyme A biosynthesis,niacin and nicotinamide metabolism.Conclusion:1.It can improve the clinical symptoms associated with dampness and paralysis in patients with dyslipidemia and improve the quality of life of patients.2.The efficacy of vapor therapy and lipid regulating method is the result of the dual action of vapor water fumigation and moisture-lowering herbs,but the key link of the lipid-lowering effect of vapor therapy and lipid regulating method mainly lies in the moisture-lowering herbs.3.Vapor therapy can regulate the metabolism of linoleic acid,the biosynthesis of pantothenate and coenzyme A,and the metabolism of niacin and nicotinamide in patients with dyslipidemia,and the mechanism of action of vapor therapy for the treatment of dyslipidemia is related to its ability to regulate lipid metabolism pathways. |
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