| Objective:The purpose of this study was to objectively evaluate the efficacy and safety of Shugan Jianpi Method in the treatment of non-alcoholic steatitis(NASH)through clinical observation,to explore the essence of TCM syndrome in NASH,and to provide new treatment methods and ideas for clinical treatment of this disease.Methods:70 NASH patients who met the inclusion criteria were randomly divided into the treatment group and the control group using randomized controlled trials,with 35 cases in each group.In the control group,lifestyle intervention and oral administration of diammonium glycyrrhizinate enteric-coated capsules were performed;the treatment group,on the basis of the control group,prescription drug therapy with Shugan Jianpi method was added,and the course of treatment was 12 weeks.Observe and record two groups of patients with liver/spleen CT ratio,controlled attenuation parameter(CAP)and TCM syndrome score,serological indexes(ALT,AST,GGT,TC,TG),body mass index(BMI),waist hip ratio(WHR)and so on,before and after the treatment,the patients of treatment group and control group needs to be tested,include vital signs,blood routine,urine routine,stool routine + OB test,kidney function,electrocardiogram inspection,to evaluate the safety.SPSS software was used for analysis the above indexes and compare the clinical efficacy of the two groups.Results:1.Comparison of imaging indexes: after treatment,the CT ratio of liver/spleen increased significantly in both groups,and CAP value decreased significantly,with statistically significant difference(p < 0.05).After the treatment,the CT ratio of liver/spleen in the treatment group was significantly higher than that in the control group(p<0.05).CAP value of the treatment group was significantly lower than that of the control group,and the difference was statistically significant(p<0.05).2.Comparison of TCM syndrome points: after treatment,the total TCM syndrome points of patients in the treatment group(7.49± 4.62)were significantly reduced compared with those before treatment(14.94 ± 4.61).The total score of the control group(10.26 ± 4.35)was significantly lower than that before treatment(14.77 ± 4.69),and the difference was statistically significant(p<0.05).After treatment,the total score of the treatment group(7.49 ± 4.62)was significantly lower than that of the control group(10.26 ± 4.35),and the difference was statistically significant(p<0.05).3.Compared with the quantitative points of TCM syndromes,the quantitative points of rib distension and tightness,depression and discomfort,tiredness and fatigue,abdominal pain and diarrhea,abdominal distension and discomfort,loss of appetite,nausea and vomiting,good and excessive breath and other symptoms in the treatment group were significantly decreased after treatment,withstatistically significant differences(p<0.05).In the control group,only the quantitative scores of symptoms such as flank distension and tightness,depression and discomfort,abdominal distension and discomfort,inappetence,nausea and vomiting,and good breath decreased significantly compared with those before treatment,and the differences were statistically significant(p< 0.05).In addition,compared with the control group,the quantitative scores of flank distension and tightness,depression and malaise,abdominal pain and diarrhea,abdominal distension and discomfort in the treatment group decreased significantly,with statistically significant differences(p<0.05).4.Comparison of serological indexes : after 12 weeks of treatment,serum ALT,AST,GGT,TC and TG in the treatment group were significantly decreased compared with that before treatment,with statistically significant differences(p<0.05).Serum ALT,AST,GGT and TG in the control group decreased significantly after treatment compared with before treatment,and the difference was statistically significant(p<0.05).TC decreased compared with that before treatment,and the difference was not statistically significant(p>0.05).After treatment,serum ALT,AST,GGT,TC and TG in the treatment group were significantly decreased compared with the control group(p<0.05).5.Comparison of obesity index(BMI,WHR)showed that both BMI and WHR of the treatment group improved after treatment,and the difference was statistically significant(p<0.05).There was no significant difference in BMI and WHR between the control group before and after treatment(p > 0.05).After treatment,thedifference between the two groups was statistically significant(p<0.05).6.Overall efficacy comparison: after the end of treatment,the total effective rate of patients in the treatment group was85.71%;The total effective rate in the control group was71.42%.Compared between the two groups,the overall efficacy of the treatment group was higher than that of the control group,and the difference was statistically significant(p<0.05).7.Safety comparison: no serious adverse events or adverse reactions occurred during the treatment of patients in the two groups,and no clinically significant changes were found in safety indicators such as vital signs,blood routine,urine routine,stool routine,renal function and electrocardiogram.Conclusion:Shugan Jianpi Method has significant clinical efficacy and safety in the treatment of NASH,and can significantly improve the CT ratio of liver/spleen,TCM syndromes,liver fat content,liver function,blood lipid,waist-hip ratio and body mass index of NASH patients.The study revealed that qi stagnation and pathogenic obstruction is the pathogenesis of NASH,and Shugan Jianpi Method has the function of transforming qi and dispersing pathogenic factors,which is an important treatment method for this disease and deserves further study. |
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