Phase Ⅳ Clinic Trial On Huazhi Rougan Granules In Treatment Of 50 Cases Of Nonalcoholic Simple Fatty Liver Disease

Objective: To evaluate the safety and efficacy on Huazhi Rougan granules in treatment of nonalcoholic simple fatty liver disease(syndrome of dampness and heat obsructing the middle).Methods: From July 2020 to April 2021,50 patients with nonalcoholic simple fatty liver disease(syndrome of dampness and heat obsructing the middle)were selected from the gastroenterology outpatient clinic of the Second Affiliated Hospital of Heilongjiang University of Chinese Medicine.The group was treated with Huazhi Rougan granules for 24 weeks.The patient would out of the group if the ratio of liver-to-spleen CT ≥1.0 after 12 weeks,because it is the end point of clinical research.In the study,we have observed the ratio of liver-to-spleen CT,scores of traditional Chinese medicine syndrome,serological index and other safety indexes of the patients.Adverse events were recorded.The data were analyzed by SAS 9.4 software.Results: There were 30 adverse events in this trail,and the incidence of adverse events was 60%.The adverse reactions related to the experimental drug were judged to occur in 19 times of 15 patients,all of which were known general adverse reactions.The incidence of adverse reactions was 30%.According to systematic analysis,digestive system reaction was occured 18 times and fever reaction was occured 1 times.Combined with other medications was no significant difference in adverse drug reactions(p>0.05).After treatment,the ratio of liver-to-spleen CT showed that the total effective rate of FAS was 48.00%.The results of PPS and FAS showed the same trend.After treatment,the scores of TCM syndromes showed that the total effective rate of FAS was 80.00%.The results of PPS and FAS showed the same trend.The scores of TCM syndromes after treatment were significantly lower than those before treatment(p<0.05).The results of PPS were consistent with those of FAS.The scores of the single symptom of TCM syndrome after treatment were lower than those before treatment.Except the symptoms of anorexia,the difference of other 4 symptoms was statistically significant.The results of PPS were consistent with those of FAS(p<0.05).The clinical controllable rate of ALT,AST,γ-GGT,TBIL were 23.81%,66.67%,23.08%and 71.43% respectively.The total effective rate of blood fat was 59.52%.The results of PPS and FAS showed the same trend.Conclusion: Huazhi Rougan granules in treatment of nonalcoholic simple fatty liver disease(syndrome of dampness and heat obsructing the middle)can effectively increase the ratio of liver-to-spleen CT,serological index and the clinical symptoms of patients.It has a slightly adverse reaction of clinical use and the clinical efficacy and safety is good.