| Objective:The use of steam therapy lipid modulation method for the treatment of hyperlipidemia patients with wet turbidity obstruction was used,and atorvastatin calcium was used as the control group to observe the clinical efficacy and safety of autotherapy lipid regulation method compared with statins in the treatment of hyperlipidemia,which provided a new TCM method for the clinical treatment of hyperlipidemia.Methods:This trial adopts a multicenter,randomized,single-blind,non-inferior,statin parallel controlled study design,using the formula of non-inferiority test sample size,the δ is determined to be 0.15,and a total of 240 patients with wet turbidity obstruction hyperlipidemia from May 2021 to June 2022 from Guang Anmen Hospital of the Chinese Academy of Chinese Medical Sciences,Qingdao Traditional Chinese Medicine Hospital,Linyi Central Hospital,and Linyi Traditional Chinese Medicine Hospital outpatient clinics and wards were selected as the research subjects.They were randomly divided into treatment and control groups,with 120 patients in each group.Central randomization and data management were undertaken by a third party,random sequences were generated by SAS 9.2 software,and statistical analysts were blinded in this study.The treatment group was treated with steam therapy lipomodulation(steam therapy lipid adjustment formula:Zexie,Cangzhu,Danshen,Bohe,Tougucao,Shiliuqi,etc.)for 8 weeks,and the control group was given oral atorvastatin calcium 20mg(Pfizer Pharmaceuticals Limited)every night with a treatment period of 8 weeks.The efficacy and safety of the two groups before and after treatment were observed.The efficacy indexes included the main efficacy indicators and the secondary efficacy indicators,the main efficacy indicators were:total lipid-lowering effective rate,total cholesterol,low-density lipoprotein,triglycerides,high-density lipoprotein,atherosclerotic index;Secondary efficacy indexes included:ApoA1,ApoB,LP(a),TCM syndrome points;Safety indicators include:liver function,renal function,muscle enzymes,ALP and LDH,electrolytes,and blood count.The data analysis is carried out by SAS9.2 software,according to the characteristics of data distribution,the comparison between numerical data is t-test,ANOVA,rank sum test,grade data comparison is used rank sum test,and counting data comparison is used chi-square test.Results:A total of 240 patients were admitted in this trial,216 patients completed 8 weeks of treatment,and 24 cases were shed,including 109 patients in the treatment group and 107 cases in the control group.1.Comparison of the main efficacy indicators:(1)After 8 weeks of treatment,the total effective rate of lipid lowering in the treatment group was 91.74%,the total effective rate of lipid lowering in the control group was 96.26%,the difference between the treatment group and the control group was not statistically significant(P>0.05),and the difference in the total lipid-lowering effective rate between the treatment group and the control group was less than 15%;(2)Both the treatment group and the control group could reduce total cholesterol,and after 8 weeks of treatment,the numerical difference between the treatment group and the control group was significant(P<0.01),the control group was significantly lower than that of the treatment group,the effective rate of reducing total cholesterol in the treatment group was 74.31%,the effective rate of reducing total cholesterol in the control group was 88.79%,the difference between the treatment group and the control group was statistically significant(P<0.01),and the difference in effective rate between the treatment group and the control group was less than 15%;(3)Triglycerides could be reduced in both the treatment group and the control group,and after 8 weeks of treatment,the numerical difference between the treatment group and the control group was statistically significant(P<0.05),the effective rate of reducing triglycerides in the treatment group was 52.29%,the effective rate of reducing triglycerides in the control group was 59.81%,the difference in response rate between the treatment group and the control group was not statistically significant(P>0.05);(4)Both the treatment group and the control group can reduce LDL,8 weeks of treatment,the numerical difference between the treatment group and the control group is significant(P<0.01),the control group is significantly lower than the treatment group,the effective rate of reducing LDL in the treatment group is 49.54%,and the effective rate of reducing LDL in the control group is 80.37%,And the difference in response rate between the treatment group and the control group was statistically significant(P<0.01);(5)The treatment group and the control group had a certain effect on increasing HDL,and after 8 weeks of treatment,the numerical difference between the treatment group and the control group was not statistically significant(P>0.05),the effective rate of increasing HDL in the treatment group was 37.61%,and the effective rate of increasing HDL in the control group was 32.71%,There was no significant difference in response rates between treatment and control groups(P>0.05).(6)Both the treatment group and the control group could reduce the atherosclerosis index(AI),and after 8 weeks of treatment,the effective rate of reducing the atherosclerosis index in the treatment group was 71.56%,the effective rate of reducing the atherosclerosis index in the control group was 84.11%,the difference in the effective rate between the treatment group and the control group was statistically significant(P<0.01).2.Comparison of secondary efficacy indicators:(1)The effective rate distribution of medical symptom improvement in the two groups was compared,8 weeks of treatment,the effective rate of the treatment group was 85.32%,the effective rate of the control group was 42.99%,and the effective rate of treatment to improve the TCM syndrome score was significantly higher than that of the control group.The difference was statistically significant(P<0.01);(2)After treatment between the treatment group and the control group,the level of ApoAl index before and after treatment and the level of ApoA1 index between the two groups were compared,and the results showed no significant statistical significance(P>0.05);(3)After treatment between the treatment group and the control group,the level of ApoB1 index between the two groups and the level of ApoB1 index in the treatment group showed no significant statistical significance(P>0.05),and the comparison between the control group before and after treatment was statistically significant(P<0.01);(4)after treatment The level of LP(a)index before and after treatment and the level of LP(a)index between the two groups were compared,and the results showed no significant significance(P>0.05).3.Safety indicators:(1)There was 1 case of ALT elevation in the treatment group,no AST elevation,6 cases of ALT elevation and 4 cases of AST elevation in the control group,and the abnormal rate of ALT and AST between the two groups was compared.There were significant differences(P<0.01);(2)there was 1 case of Cr increase in the treatment group,no Cr increase in the control group,no significant increase in the two groups(P>0.05),and no BUN increase in the treatment group and control group;(3)4 cases of CK abnormality in the treatment group and 1 case of CK abnormality in the control group,no statistical difference between the two groups(P>0.05);1 case of CK-MB abnormality in the treatment group,no CK-MB abnormality in the control group,no statistical difference between the two groups(P>0.05);(4)There was no lactate dehydrogenase and alkaline phosphatase elevation in the treatment group and the control group;(5)1 case K in the treatment group+abnormal,there was no K+abnormality in the control group,no statistical difference between the two groups(P>0.05),and no Na+and Cl-abnormalities were seen in the two groups;(6)There was 1 case of hemoglobin(HGB)abnormality in the control group,and there was no significant difference between the two groups(P>0.05);1 case of platelet(PLT)abnormality in the treatment group,no PLT abnormality in the control group,no statistical difference between the two groups(P>0.05),and no white blood cell(WBC)or red blood cell(RBC)abnormalities in both groups.Conclusion:The effect of steam therapy lipid modulation in the treatment of hyperlipidemia is obvious,and its total lipid-lowering effective rate is non-inferior to atorvastatin calcium.The treatment of hyperlipidemia by steam therapy lipid adjustment method is green and safe,and there is no obvious liver and kidney function damage;Steam therapy lipid modulation can effectively improve the clinical symptoms of patients with hyperlipidemia. |
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