| Objective:Observing and comparing the clinical efficacy of Ursodeoxycholic acid(UDCA)combined with Hydrochlorochloroquine(HCQ),Ursodeoxycholic acid combined with Total glucosides of paeony(TGP)for the treatment of refractory Primary biliary cholangitis(PBC),to provide effective combination treatment regimens for the treatment of refractory PBC.Methods:Collecting the clinical data of 67 patients with refractory PBC who visited the Second Hospital of Shanxi Medical University during January 2014 to December 2017,and who did not respond well to the Paris I criteria.Sixty-seven patients with refractory PBC were divided into groups A,B,and C according to the difference of the treatment regimens.Group A continued to take the original dose of ursodeoxycholic acid(22 cases),group B combined with HCQ(22 cases)on the basis of the original dose of ursodeoxycholic acid,and group C combined with TGP on the basis of the original dose of ursodeoxycholic acid(23 cases),treating for 1 year.Collecting and comparing the following data of the three groups before and after treatment:The number of patients in each group meeting the criteria of Barcelona at 12 weeks,24 weeks,36 weeks,and 48 weeks and the corresponding response rate,the hepatic fibrosis index,the fatigue scores,the pruritus scores,the percentage of Treg and Th17 cell,the ratio of Th17/Treg,the occurence of side effects.In addition,collecting the index of liver fibrosis,the percentage of Th17 and Treg cell and the ratio of Th17/Treg of 22 healthy volunteers who matching with the three groups at gender composition and age for serving ascontrol.The above data using SPSS22.0 software for statistics and analysis.Results:1.Peripheral blood Th17 、 Treg cell percentage and Th17/Treg ratio: Before treatment,the percentage of Th17 and Th17/Treg ratio in the three groups were higher than the normal control group(P<0.001),the percentage of Treg cell was significantly lower than the normal control group(P<0.001);Comparison among the three groups,there were no statistical difference(P>0.05),three groups were comparable.After 1 year of treatment,group A compared with before treatment,there were no statistical difference(P>0.05);the percentage of Th17 cell in groups B and C decreased compared with before treatment(P<0.05),the percentage of Treg cell increased significantly compared with before treatment(P < 0.001),Th17/Treg ratio decreased significantly than before treatment(P<0.001).After 1 year of treatment,comparison between group A and B,the percentage of Th17 cell in group B was lower than group A(P<0.05),the percentage of Treg cell was higher than group A(P<0.05),Th17/Treg ratio was significantly lower than group A(P<0.001);comparison between group A and C,there were no statistical difference in the percentage of Th17 cell(P>0.05),the percentage of Treg cell was higher than group A(P<0.05),Th17/Treg ratio was significantly higher than group A(P<0.001).2.Liver fibrosis index: Before treatment,compared with the normal control group,the PCIII,IVC,HA and LN increased significantly in the three groups(P <0.001).Before treatment,there were no statistical difference among the three groups in PCIII,IVC,HA and LN(P > 0.05),three groups were comparable.After 1 year of treatment,group A compared with before treatment,IVC and HA decreased compared with before treatment(P<0.05),PCIII and LN decreased significantly compared with before treatment(P < 0.001);B,C groups compared with before treatment,PCIII,IVC,HA,and LN decreased significantly(P<0.001).After 1 year of treatment,comparison between group A and B,there were no statistical difference between group A and B in PCIII,IVC,HA and LN(P>0.05);comparison with group A,PCIII and IVC decreasedsignificantly in group C(P<0.001),HA decreased compared with group A(P<0.05),there was no statistical difference in LN(P>0.05)。3.Fatigue,Pruritus score: Before treatment,there were no statistical difference among the three groups in fatigue and itch score(P > 0.05),three groups were comparable.After 1 year of treatment,three groups compared with before treatment,fatigue and itch scores were decreased than before treatment,but there were no statistical difference(P>0.05).4.Response rate: Treatment for 12 weeks,there were no statistical difference among the three groups in response rates(P>0.05).Treatment for 36 weeks,48 weeks,the response rates of group B were higher than group A(P<0.05);treatment for 24 weeks,36 weeks,48 weeks,the response rates of group C were higher than group A(P <0.05).Comparison of response rate in groups B and C,there were no statistical difference(P>0.05).Treatment for 48 weeks,the response rates of groups A,B,and C were13.64%,40.91%,and 47.82%,respectively.5.Adverse reactions:The three groups were well tolerated,and no serious adverse reactions occurred.Conclusion:1.Ursodeoxycholic acid combined with Hydroxychloroquine or Total glucosides of paeony can effectively improve the biochemical response rate of refractory PBC,and lessside effect,well tolerance.2.Hydroxychloroquine and Total glucosides of paeony have the effect of regulating the immune imbalance of Th17/Treg in PBC patients.3.Hydroxychloroquine and Total glucosides of paeony have no the function for relieving pruritus and fatigue in PBC patients4.The Total glucosides of paeony can improve the liver fibrosis of PBC patients. |
PDF Full Text Request