Objective:To observe the clinical efficacy of Shenqi Jiangzhi decoction in the treatment of metabolic-associated fatty liver disease(MAFLD)with internal stagnation of dampness and turbidity,and to evaluate the therapeutic effect and safety.Methods: A total of 60 patients with MAFLD who met the inclusion criteria in Xiangyang Hospital of Traditional Chinese Medicine were randomly divided into treatment group and control group,with 30 cases in each group.All patients received conventional treatment(diet therapy and physical exercise),and the control group was treated with polyene phosphatidylcholine capsules on the basis of conventional treatment.The treatment group was treated with Shenqi Jiangzhi decoction on the basis of conventional treatment.The course of treatment in both groups was 12 weeks.The changes of Body Mass Index(BMI),liver function,blood lipid,Controlled attenuation parameters(CAP),liver color Doppler ultrasound grade and TCM symptom score before and after treatment were compared between the two groups.Statistical software SPSS26.0 was used to analyze the observed data and evaluate the efficacy of the two methods.Results :(1)Both treatments could significantly improve BMI.The improvement of BMI in the experimental group was significantly better than that in the control group(P < 0.05).(2)ALT,AST and GGT were significantly improved in both groups.The improvement of liver function(ALT,AST,GGT)in the experimental group was significantly better than that in the control group(P < 0.05).(3)Both treatment regimens could significantly improve TC,TG,LDL-C(P < 0.05),but not HDL-C(P > 0.05).The improvement of TC,TG and LDL-C in the experimental group was significantly better than that in the control group(P < 0.05),but the improvement of HDL-C in the two groups was similar(P > 0.05).(4)Both treatments could significantly improve CAP and reduce the grade of liver color Doppler ultrasound.The improvement of imaging indicators(CAP,liver color Doppler ultrasound grade)in the experimental group was significantly better than that in the control group(P < 0.05).(5)Both treatments could significantly improve the TCM symptoms of patients.Compared with the experimental group,the experimental group significantly improved the discomfort or fullness of the right flank,body obesity,body weight,chest and stomach fullness,fatigue and weakness(P < 0.05),and the improvement of sticky stool,loss of appetite,dizziness and nausea was particularly significant(P < 0.01).(6)The effective rate of TCM syndrome in the experimental group was 90%.The effective rate of TCM syndrome in the control group was 58.6%,and the difference between the two groups was significant(P < 0.01).(7)The total effective rate was 86.7% in the experimental group and 58.7% in the control group.There was significant difference between the two groups(P < 0.05).(8)There were no abnormal changes in the basic vital signs and safety indicators before and after treatment in the two groups,and the overall safety was observed.Conclusion: Shenqi Jiangzhi decoction is much better than polyene phosphatidylcholine capsules in relieving the TCM symptoms,regulating liver function and blood lipids,and reducing the degree of fatty liver in patients with metabolic related fatty liver disease of dampness and turbidity stopping syndrome.In this clinical study,there were no obvious adverse reactions and good safety,which is worthy of promotion. |