OBJECTIVE:To observe the effects of Xinfeng capsule on the apoptosis of peripheral blood CD4 + T lymphocytes and changes in the Fas/FasL-mediated apoptotic pathway in patients with rheumatoid arthritis (RA).METHODS:A total of 28 RA patients were included in the study;they were randomly divided into the Xinfeng capsule (XFC) group (3 capsules,3 per day)and the leflunomide (LEF) group (1 pellet,once per night).The treatment course in each groups was 12 weeks.The normal control (NC) group consisted of 10 healthy people.The apoptotic rate was examined using flow cytometry.Fas,FasL,caspase 8,caspase 3,bcl-2,and bax mRNA were examined using qRT-PCR.Apoptotic proteins Fas,FasL,caspase 8,and caspase 3 were examined using west blotting.RESULTS:After treatment,patients in the two groups all showed some trend of improvement.Disease activity indexes,joint ming stiffness time,joint swelling/tendess number,health assessment questionnaire (HAQ) score,RA quality of life (RAQOL) questionnaire,and self-rating anxiety scale (SAS),as well as all apoptotic related indicators were reduced in both groups after treatment with no significant difference between groups.But the improvement in terms of the self-rating depression scale (SDS) in the XFC group was better than in the LEF group.RA patients showed lower apoptotic rates in CD4+ T cells,lower bax,Fas,caspase 8,and caspase 3 mRNA,and less protein expression of Fas,caspase 8,and caspase 3 than in the NC group.These indicators increased after treatment.However,the level of Bcl-2 mRNA was higher in the XFC group than in the NC group before treatment,and it subsequently decreased.The XFC group expressed lower Bcl-2 mRNA than the LEF group.Negative correlations were found between ESR and the apoptotic rate in CD4+ T cells,Fas,and caspase 3;CRP and Fas;and,swollen joint count and Bax,while positive correlations were found between ESR and Bcl-2.CONCLUSION:XFC can regulate the Fas/FasL system and promote CD4+ T cell apoptosis and thus reduce the abnormal immune response,which can improve symptoms in RA patients.