Clinical Study Of Yexiazhu Capsule In The Treating Dampness-heat Intrinsic Type Of Non-alcoholic Fatty Liver

Objective:To evaluate the effectiveness of Ye Xia Zhu capsule in the treatment of damp-heat syndrome of non-alcoholic fatty liver disease,and observe its safety,so as to provide clinical trial data and selection basis for TCM treatment of non-alcoholic fatty liver disease.Methods:A total of 72 observers meeting the inclusion criteria were randomly selected and divided into treatment group and control group,36 in each group.Control group: Yishanfu2 capsules(456mg)each time,Vitamin E soft capsule 1 capsule(100mg)each time,orally,three times a day;Treatment group: Ye Xia Zhu Capsule,oral,3 capsules(0.75g)each time,three times a day.The treatment course was 3 months and the follow-up was 3 months.All participants were instructed to reduce the intake of high lipid diet,refrain from overeating and alcohol,take appropriate physical exercise,and suspend the use of other drugs that may affect the observation during treatment.After the observation,laboratory indicators,TCM syndrome scores,drug safety and effectiveness data of subjects in the two groups were collected for statistical analysis,evaluation and comparison,and conclusions were drawn.Results:1.Before treatment: TCM syndrome scores,disease course,liver function(ALT,AST,GGT),blood lipid(TG),body mass index(BMI),interleukin-6(IL-6)and data analysis results of the two groups were not statistically significant(P > 0.05),indicating comparability.2.Before and after treatment: The results of liver function(ALT,AST,GGT),blood lipid(TG),body mass index(BMI),interleukin-6(IL-6)TCM syndrome scores of the two groups before and after treatment were compared with those before and after treatment(P< 0.05).3.After treatment:(1)There were no significant differences in liver function(ALT,AST,GGT),blood lipid(TG),body mass index(BMI)and interleukin-6(IL-6)between 2groups(P > 0.05);(2)TCM syndrome score between groups: there was statistical significance(P < 0.05);(3)The curative effect of TCM syndrome between groups: there was statistical significance(P < 0.05);(4)Comprehensive efficacy and effective rate:According to the laboratory test results and clinical symptom scores of the two groups,the comprehensive efficacy was determined.The effective rate of the treatment group and the control group was 93.30% and 90.00%,with no statistical significance(P > 0.05).(5)Liver B-ultrasound: the effective rate of the treatment group and the control group were 76.66%and 83.33%,with no statistical significance(P > 0.05).4.Safety evaluation:(1)There was no statistical significance in blood routine and renal function between 2 groups before and after the test(P > 0.05);(2)During the trial,there were no significant abnormalities in the patients’ vital signs,routine bowel movements and12-lead electrocardiogram,and no adverse reactions related to experimental drugs.Conclusion:Ye Xia Zhu Capsule has a significant effect on improving TCM syndromes of patients,and can reduce liver function(ALT,AST,GGT),blood lipid(TG),body mass index(BMI),interleukin 6(IL-6)levels of patients,reduce inflammation,and protect the liver.At the same time,no obvious adverse reactions were found during the observation and follow-up,which is relatively safe.