The Effect Of Qingying Lidan Recipe Combined With UDCA On The Biochemical Response Rate Of Primary Biliary Cholangitis And The Experimental Study On TGF-?1 And Smad3

Part 1Objective:To observe the UDCA response of Qingyinglidan Formula combined with UDCA in the treatment of PBC patients and the effect on serum TGF-?1 and Smad3.Methods:a randomized controlled study was used to include 71 cases of PBC patients in Shuguang Hospital.They were randomly divided into UDCA control group and Qing Ying Lidan Formula combined with UDCA treated group?32 cases each?.The changes of UDCA response,liver biochemical indexes,TCM symptom score and serum TGF-?1and Smad3,were observed before and after 12 months treatment.Results:1.After treatment,The number of UDCA response cases in the treatment group was 28,and the response rate was 87.5%;The number of UDCA response cases in the control group was 20,and the response rate was 62.5%;the difference was statistically significant?P<0.05?;2.After treatment,the ALT,AST,GGT and ALP in the treatment group decreased compared with the control group,the difference was statistically significant?P<0.05?;3.After treatment,the TCM syndrome score in the treatment group decreased compared with the control group,the difference was statistically significant?P<0.05?;4.After treatment,APRI in the treatment group decreased compared with the control group,the difference was statistically significant?P<0.05?;5.After treatment,serum TGF-?1 and Smad3 in the treatment group decreased compared with the control group,the difference was statistically significant?P<0.05?.Conclusion:The Qingyinglidan formula combined with UDCA is superior to UDCA monotherapy in the treatment of PBC.The Qingyinglidan formula may increase the UDCA response and decrease the ALT,AST,GGT,ALP,APRI,the TCM syndrome score and serum TGF-?1 and Smad3.Part 2Objective:To explore the regulatory effects of TGF-?1 and Smad3 in liver in DDC fed mice model treated by Qingyinglidan Formula.Methods:DDC fed cholestasis mice model was established.C57BL6 mice were randomly divided into the normal group,the model group,the UDCA group(0.1g/kg^-1d^-1)as a positive control,the low dose of Qingyinglidan Formula group(1.9g/kg^-1d^-1),the middle dose of Qingyinglidan Formula group(3.8g/kg^-1d^-1)and the high dose of Qingyinglidan Formula group(7.6g/kg^-1d^-1).After 2 weeks of treatment,the serum ALP,TBil,ALT were detected,TGF-?1 and Smad3 in liver detected by ELISA test.Results:1.Compared with the normal group,the TBil,ALT and ALP were increased in the model group.Compared with the model group The ALP,TBil and ALT were decreased in the Qingyinglidan Formula group and UDCA group.2.In the model group,Liver showed inflammatory cell activity and fibrous tissue proliferation and other pathological changes.Compared with the model group,the pathological damage in the UDCA group and the Qingyinglidan Formula group were obviously improved.3.In the model group,the levels of TGF-?1 and Smad3 in liver were higher.The levels of TGF-?1 and Smad3 in liver were significantly decreased in the Qingyinglidan Formula group and UDCA group.Conclusion:The Qingyinglidan Formula can effectively improve the biochemical indexes of DDC mice,reduce hepatic cholestasis and fibrosis around the portal area.The Qingyinglidan Formula may reduce bile stasis liver fibrosis by down-regulating the levels of TGF-?1 and Smad3 in the liver.