| Objective:This study objectively evaluated the clinical efficacy and safety of Shuganhewei Decoction in the treatment of nonalcoholic fatty liver disease(NAFLD)through clinical observation and study,and explored its possible mechanism of action through animal experiments.providing practical theoretical basis for the clinical treatment of NAFLD.Methods:○1 Clinical observation: 62 patients who met the inclusion criteria for NAFLD were randomly divided into two groups,the Chinese medicine group and the Western medicine group,with 31 cases in each group.The traditional Chinese medicine group was given Shugan Hewei Decoction(Shugan Hewei Decoction was prepared by Liuzhou Hospital of Traditional Chinese Medicine in strict accordance with the proportion requirements),twice a day,2 doses each time;the western medicine group was given vitamin E soft capsules,100 mg each time,3 times a day.The treatment cycle of both groups was 12 weeks.The clinical effect of Shugan Hewei Decoction on NAFLD was objectively evaluated by comparing the changes of TCM syndrome score,blood lipid,liver function,liver hardness and fat attenuation in patients with NAFLD before and after treatment between the TCM group and the western medicine group.○2 Animal experiments: 34 SPF grade SD male rats,weighing220±20g,were randomly divided into 6 rats as blank group and fed with ordinary diet.The remaining rats were prepared according to NAFLD model and fed high fat diet for 8 weeks.At the end of the 8th week,4 rats were selected to verify the success of modeling.After the success of the model,the remaining 24 rats in the high fat diet group were randomly divided into model group,Shugan He Wei decoction low-dose,medium-dose and high-dose groups,with 6 rats each.The Shugan He Wei groups were given Shugan Hewei decoction at low,medium and high doses by gavage for 4 weeks,and the serum and liver samples were collected until the end of the 12 th week.The serum liver function and blood lipid levels of the rats in each group were detected by automatic biochemical instrument.The pathological sections of liver tissue were stained and the pathological morphology was observed by optical microscope.The levels of UCP2,SOD and MDA in serum were detected by ELISA,and the expression levels of AMPK,SIRT1 and PCG-1αwere detected by Western Bolt.Results:(1)Clinical trials: A total of 60 effective cases were included in clinical observation.After 12 weeks of intervention with Shugan Hewei Decoction or Vitamin E soft capsule,statistical analysis and comparison showed that the clinical efficacy,TCM syndrome score,liver function,blood lipid,liver hardness and liver cell fat attenuation indexes of the two groups were significantly improved after treatment(P < 0.05),and the differences were statistically significant.Compared with western medicine group,the above indexes in Shugan Hewei groups improved significantly(P < 0.05).(2)Experimental study: After 4 weeks of intervention with Shugan He Wei Decoction,the general condition of rats in each Shugan He Wei Decoction group was improved compared with that before treatment.Histopathology: Pathological sections of model group rats showed structural disorder of hepatocytes,infiltration of a large number of adipose vacuoles and fusion of adipose vacuoles.Compared with the pathological slices of liver in the model group,the adipose vacuoles of liver tissue cells in each treatment group were reduced to varying degrees,and the cell structure was restored to varying degrees,and the high dose group had the best improvement effect.In terms of liver function,ALT and AST were significantly increased in model group compared with blank group(P < 0.01).Compared with model group,the serum ALT and AST levels in Shugan and stomach groups were decreased to varying degrees,and the high dose group had the best effect in improving liver function(P < 0.01).Blood lipid indexes(TG,TC,LDL-C)in model group were significantly increased compared with blank group(P < 0.05),while HDL-L in model group was decreased compared with blank group,and the difference was statistically significant.After Shugan Hewei Decoction intervention,blood lipid indexes in all TCM groups were improved compared with model group(P < 0.05).The SOD and UCP2 levels in serum of model group were significantly decreased compared with blank group(P < 0.01).Compared with model group,SOD and UCP2 in Shugan He Wei Decoction treatment groups were not increased to some extent,and the increase was the most obvious in high dose group(P < 0.01).Compared with blank group,MDA in serum of model group was significantly increased(P < 0.01).The serum MDA in all treatment groups decreased to different degrees,and the decrease was most obvious in Shugan Hewei Decoction high-dose group(P <0.01).The expressions of AMPK,SIRT1 and PGC-1α in liver tissues of all groups were compared,and the expressions of AMPK,SIRT1 and PGC-1α in model group were significantly down-regulated compared with blank group(P < 0.01).The expressions of AMPK,SIRT1 and PGC-1α in Shugan He Wei Decoction groups were up-regulated to varying degrees compared with model groups,and the up-regulation was most significant in Shugan He Wei Decoction high-dose groups(P < 0.05).Conclusion:(1)Clinical observation: Shugan Hewei Decoction has good safety and clinical efficacy in the treatment of NAFLD by improving clinical symptoms and reducing liver function,blood lipid,liver hardness,fat attenuation and other indicators.(2)Animal experiments showed that Shugan Hewei Decoction could improve hepatic steatosis,inhibit oxidative stress,and promote lipid metabolism in NAFLD rats.This protective effect may be related to the activation of AMPK/SIRT1/PGC-1α.And promote lipid metabolism in NAFLD rats.This protective effect may be related to the activation of AMPK/SIRt1 /PGC-1α signaling pathway,thus inhibiting oxidative stress injury and fat hoarding. |
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