| Purpose:To observe the clinical efficacy of Jueming prescription in the treatment of non-alcoholic steatohepatitis(dampness-heat complicated hepatophile),and to explore and analyze the therapeutic effect of traditional Chinese medicine in the treatment of non-alcoholic steatohepatitis by establishing a rat model of non-alcoholic steatohepatitis..MethodClinical observation:60 patients with non-alcoholic steatohepatitis who met the criteria of damp-heat syndrome were selected and randomly included into the observation group or control group.The observation group was treated with Jueming prescription(1 dose per day,divided in the morning and evening),and the control group was treated with enteric soluble capsules of diammonium glycyrrhizinate(150mg/time,3 times per day)for 1 month.After the treatment,the results of BMI,TCM syndrome score,efficacy index,liver function,blood lipid and liver b-ultrasound were compared between the two groups.Experimental study:45 healthy male SD rats were selected for normal drinking,foraging and daily activities.After 7 days of adaptive feeding,they were randomly divided into a blank group of 8 rats and a model group of 37 rats.The blank group was fed with normal feed,while the model group was fed with high-fat feed.At the end of 8 weeks,1 rat in the blank group and 2 rats in the model group were randomly selected and put to death.Liver tissues were taken for HE staining and comparison.The success of modeling in the model group was determined by the degree of fatty change and inflammation in the liver tissue.The liver function(ALT,AST)and blood lipid of all the rats was measured by weighing and collecting blood after successful modeling.Then,35 rats in the model group were randomly divided into 5 groups(control group,positive drug group,low,medium and high dose group of Jueming prescription),with 7 rats in each group.Normal saline was administered to the blank group and the control group.The positive group was given enteric capsule suspension of diammonium glycyrrhizinate by gavage of 75mg/kg.In the other groups,the drugs were given by gavage with low,medium and high concentration of Jueming prescription(3.17,6.34,12.68 g crude drug/kg),respectively.The gavage volume of all the above rats was 10ml/kg,twice per day,continuously for 6 weeks.After fasting for 12h at the end of the experiment,they were all put to death after weighing and recording.The liver was weighed and abdominal aortic blood was taken,serum was separated,and ALT,AST,TCHO,TG,HDL-C,LDL-C,and GLU were detected with automatic biochemical analyzer.Result:1.There was no statistically significant difference in the general data(sex ratio,age)of the clinical observation patients,and the comparison was comparable(P>0.05).The comparison of total effective rate of clinical efficacy showed that the observation group(86.67%)was higher than the control group(70%),and the comparison between the two groups was statistically significant(P<0.05).2.Body mass index:There was no statistical difference between the two groups before treatment(P>0.05),and both groups improved after treatment(P<0.05).Comparison between the two groups(P>0.05)suggested that there was no significant difference in the improvement effect.3.There was no significant difference in TCM syndrome score before treatment(P>0.05),but differences in scores were found in the two groups after treatment(P<0.01),suggesting that the TCM symptoms of patients in the two groups were improved compared with those before treatment.The comparison between the two groups after treatment was P<0.05,indicating that there was a statistical difference in the efficacy improvement effect between the two groups.Besides,the total effective rate of the observation group(76.67%)was higher than that of the control group(63.33%).In other words,the improvement effect of observation group on TCM symptoms(especially flank swelling pain and dry mouth pain)was more obvious than that of control group(P<0.05).4.Biochemical indicators:Before treatment,AST,ALT,GGT,TCHO,TG and other indicators in the observation group and control group were not statistically significant(P>0.05).After treatment,liver enzymes(AST,ALT,GGT)decreased in both groups(P<0.05).The comparison between the two groups suggested that the effect of reducing abnormal ALT in the observation group was better than that in the control group(P<0.05),while the effect of reducing AST and GGT in the two groups was similar.After the review of blood lipid(TCHO,TG),the comparison between the observation group(P<0.05)and the control group(P<0.05)also had the effect of lowering blood lipid,while the comparison between the two groups(P<0.05)suggested that the improvement effect of the observation group and the control group was inconsistent,and the observation group was better from the data.5.Ultrasound imaging:Before treatment,14 cases of mild fatty liver,14 cases of moderate fatty liver and 2 cases of severe fatty liver in the observation group;In the control group,there were 15 cases of mild fatty liver,12 cases of moderate fatty liver and 3 cases of severe fatty liver.By the rank sum test,P>0.05,showing no statistical significance.After treatment,3 patients in the observation group changed from moderate to mild.In the control group,1 severe patient became moderate and 1 moderate patient became mild.There was no significant change in b-ultrasound in other patients.After treatment,there was no statistical significance in the comparison between the two groups(P>0.05).6.Experimental study:Compared with the blank group,the model group not only increased significantly in weight,but also suffered liver injury(P<0.01).Compared with the control group,the high-dose group of Jueming prescription could significantly reduce the weight and liver wet weight of the rats,reduce the abnormally elevated liver enzyme AST and AST,reduce the indicators of TCHO,TG and GLU,and reduce the LDL-C as well as the HDL-C content(P<0.05).The difference was statistically significant.7.Safety:The patient did not show any obvious discomfort symptoms during the clinical observation;Rats in the model group had occasional loose stool stool,but no obvious abnormality was observed.Conclusion:Jueming prescription has a good therapeutic effect on non-alcoholic steatohepatitis(dampness-heat complicated hepatopathy),can improve clinical symptoms,reduce abnormal liver enzymes and blood lipid,and is beneficial to BMI,with no obvious adverse reactions.Experimental study also shows that Jueming prescription has the function of protecting the liver,but also has the function of lowering lipid,lowering blood sugar and so on to improve metabolic disorders.Its curative effect is reliable,no obvious toxic and side effects,in clinical worthy of promotion and application. |
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