| Objective: To evaluate the clinical efficacy and safety of Modified Dachaihu Decoction on nonalcoholic steatohepatitis with accumulation of damp-heat,and to explore its possible mechanism of action.Methods: This study intends to include 60 NASH patients who meet the criteria.The randomized controlled research method is used to randomly divide the 60 patients into a treatment group and a control group with 30 cases in each.Both groups were given basic treatment such as diet control and aerobic exercise.The control group was given oral silibinin capsules,and the treatment group was given oral modified Dachaihu decoction.The course of treatment in both groups was 12 weeks.Before and after treatment,liver function(ALT,AST,GGT,TBA),blood lipids(TC,TG),superoxide dismutase(SOD),insulin resistance index(HOMA-IR),and controlled attenuation parameter(CAP)were detected respectively.body mass index(BMI),liver B-ultrasound and evaluation of TCM symptom scores and other indicators.By arranging and analyzing the above data,the clinical efficacy of modified Dachaihu Decoction was evaluated,and its mechanism of action was discussed.Finally,its clinical safety was evaluated by three routines,renal function and electrocardiogram.Results: 1.Comparison of liver function between the two groups before and after treatment: the liver function of the two groups of patients after treatment decreased significantly compared with before treatment,and the difference was statistically significant(P<0.05);after treatment,there was no statistical difference in ALT and AST between the two groups After treatment,GGT and TBA in the treatment group were significantly lower than those in the control group,and the difference was statistically significant(P<0.05).2.Comparison of blood lipid between 2 groups before and after treatment:TG in 2 groups decreased significantly after treatment compared with before treatment,the difference was statistically significant(P<0.05);TC in the treatment group decreased significantly after treatment compared with before treatment,and the difference was statistically significant(P<0.05).The TC of control group after treatment was not significantly decreased compared with that before treatment,and the difference was not statistically significant(P>0.05).After treatment,TC and TG in the treatment group decreased significantly compared with the control group,with statistical significance(P<0.05).3.Comparison of HOMA-IR between 2 groups before and after treatment:Hom A-IR in 2 groups after treatment decreased significantly compared with before treatment,the difference was statistically significant(P<0.05);After treatment,HOMA-IR in the treatment group decreased significantly compared with the control group,and the difference was statistically significant(P<0.05).4.Comparison of SOD before and after treatment in 2 groups: SOD in 2groups increased significantly after treatment compared with before treatment,the difference was statistically significant(P<0.05);After treatment,SOD in the treatment group increased significantly compared with the control group,and the difference was statistically significant(P<0.05).5.Comparison of CAP values between 2 groups before and after treatment: CAP values in 2 groups after treatment decreased significantly compared with before treatment,with statistical significance(P<0.05);CAP value in the treatment group decreased significantly compared with the control group after treatment,and the difference was statistically significant(P<0.05).6.Comparison of BMI between 2 groups before and after treatment: BMI of 2 groups after treatment decreased significantly compared with before treatment,the difference was statistically significant(P<0.05);After treatment,BMI in the treatment group decreased significantly compared with the control group,and the difference was statistically significant(P<0.05).7.Comparison of TCM syndrome scores between the two groups of patients before and after treatment: after treatment,the patients in the treatment group had swelling pain in the flanks,whole body,abdominal distention or pain,sticky and unpleasant stools,yellow eyes,dry mouth and bitter taste,and TCM symptoms.The total score of syndromes decreased significantly compared with those before treatment,and the difference was statistically significant(P<0.05).The color of urine and the stickiness in the mouth were not significantly decreased compared with those before treatment,and the difference was not statistically significant(P>0.05).dry mouth and bitter taste,and the total score of TCM syndromes were significantly lower than those before treatment,and the difference was statistically significant(P<0.05).The yellowing of the body and eyes,the color of urine and the stickiness in the mouth were not significantly lower than those before treatment,and the difference was not statistically significant(P>0.05).Compared with the control group,the total score of Huang and TCM syndromes decreased significantly,and the difference was statistically significant(P<0.05).After treatment,the treatment group showed no significant decrease in flank fullness,whole body drowsiness,yellow urine,stickiness in the mouth and dry mouth and bitter taste compared with the control group,and the difference was not statistically significant(P>0.05).8.Comparison of TCM syndrome efficacy and B-ultrasound efficacy between the two groups after treatment: after treatment,TCM syndrome efficacy in the treatment group was significantly higher than that in the control group,the difference was statistically significant(P<0.05);After treatment,b-ultrasound efficacy in the treatment group was significantly higher than that in the control group,with statistical significance(P<0.05).Conclusions: 1.On the basis of controlling diet and aerobic exercise,modified Dachaihu decoction can significantly reduce blood lipid levels in NASH patients.It has certain effects in improving IR,oxidative stress injury,bile acid metabolism,and reducing CAP value and BMI.Its efficacy is comparable to that of silibinin capsules in improving liver function and reducing liver inflammation.2.In terms of the efficacy of TCM symptoms and B-ultrasound,Modified Dachaihu Decoction is better than Silibinin Capsules;in terms of improving abdominal distention or pain,sticky stool and yellowing of the body and eyes,Modified Dachaihu Decoction is better than silybin capsule.Silybinin capsules are remarkable.3.During the course of treatment,no obvious adverse reactions were found in the modified Dachaihu decoction,and the safety was good. |
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