| Purpose:Through retrospective analysis,to observe the clinical efficacy of compound Shengmai Yin in the treatment of patients with primary biliary cholangitis with both qi and Yin deficiency,in order to provide new ideas for the clinical treatment of patients with primary biliary cholangitis with both qi and Yin deficiency.Material and method:In this study,patients with primary biliary cholangitis with both qi and Yin deficiency in the liver disease clinic of the Affiliated Hospital of Liaoning University of Traditional Chinese Medicine from May 2018 to May 2021 were selected as research objects.64 patients with complete data and primary biliary cholangitis with deficiency of Qi and Yin were selected from the medical records according to the medication methods recorded in the medical records.Patients receiving ursodeoxycholic acid capsules alone were recorded as the control group,and patients receiving ursodeoxycholic acid capsules combined with compound Shengmayin were recorded as the treatment group.The medication methods were as follows:Control group was given ursodeoxycholic acid capsules(250mg/capsule from Losan Pharma GmbH,Germany)15mg/kg/day,orally divided into 3 times;Patients in the treatment group were also given compound Shengmai Yin on the basis of ursodeoxycholic acid(15mg/kg/day,orally divided into 3 times).The composition of compound Shengmai Yin is as follows:Radix pseudostellariae 10g,Radix ophiopogon 10g,Schisandra 10g,licorice 10g,Radix Paeoniae 15g,Radix Paeoniae 15g,Radix bupleurum 6g,Radix baicalensis 15g,Radix Astragalus 15g,Rhizome 10g,Radix atractyloides 10g,Radix angelica 10g,one dose a day,400ml decoction in water,warm in the morning and evening,for 12 weeks.The changes of liver function indexes,APRI value,FIB-4 value,PLT,IGM,TCM syndrome score and comprehensive efficacy of patients before and after treatment were observed,and the clinical efficacy of compound Shengmai Yin was objectively and systematically evaluated.Results:1.Comprehensive curative effect:in terms of TCM curative effect index and comprehensive curative effect,the treatment group showed significant advantages,compared with the control group,the difference was statistically significant(r<0.01),indicating that the overall curative effect of the treatment group was significantly higher than that of the control group.2.Serological indexes:After treatment,liver function indexes of the two groups were significantly improved by intra-group comparison,among which ALT,AST,ALP,GGT and TBA indexes were statistically significant(r<0.01),while intra-group comparison of TBIL group was statistically significant(r=0.007 in the control group and r=0.011 in the treatment group).After treatment,PLT and IGM were significantly improved in both groups,with significant statistical difference(r<0.01).After treatment,the indexes of ALT,ALP and GGT in the two groups were significantly better than those in the control group,and there were significant statistical differences between the two groups.ALT:r=0.024(r<0.05),ALP:r=0.014(r<0.05),GGT:r<0.01,The results showed that the treatment group was better than the control group in improving ALT,ALP and GGT.There was no significant difference in AST,TBIL and TBA between the two groups before and after treatment(AST:r=0.204,TBIL:r=0.564,TBA:r=0.589),indicating that there was no significant difference in the improvement of AST,TBIL and TBA between the two regiments.The IGM index of the two groups was significantly compared between the two groups(r=0.013),and the improvement of IGM index in the treatment group was significantly better than that in the control group.There was no significant difference in PLT index between the two groups(P=0.448(r>0.05),suggesting that there was no significant difference in improving platelet index between the two groups.3.Serum non-invasive diagnosis model:After treatment,APRI value and FIB-4 value in the two groups were significantly improved,with significant statistical difference(r<0.01);The comparison between groups showed that the treatment group was slightly lower than the control group,but there was no statistical difference(r>0.05).Conclusion:1.Compound Shengmai Yin can significantly reduce the TCM syndrome score of patients with primary biliary cholangitis with Qi and Yin deficiency,and the comprehensive effect is significant.2.Compound Shengmai Decoction can significantly improve liver function indexes and reduce IGM levels in patients with PBC.3.Compound Shengmai Decoction had no significant effect on APRI value and FIB-4 value of serum noninvasive diagnostic model. |