| Objective:To investigate the efficacy and safety of iguratimod combination with tofacitinib in patients with refractory moderate and severe rheumatoid arthritis(RA).Methods:The patients with refractory RA who attended Fenyang Hospital of Shanxi Province(Rheumatology and Immunology Department)from September 2021 to June 2022 and met the enrollment criteria were selected for the clinical study.The combination regimen of disease-modifying anti-rheumatic drugs was changed to iguratimod combination with tofacitinib for 12 w.Clinical data were collected before treatment,at 4w,8w and 12w:swollen joints count(SJC),tender joints count(TJC),duration of morning stiffness,clinical disease activity index(CDAI),health status assessment questionnaire(HAQ),28-joint disease activity score(DAS28)was taken,as well as laboratory tests: erythrocyte sedimentation rate(ESR),C-reactive protein(CRP),platelet(PLT),rheumatoid factor(RF),globulin and anti-cyclic citrullinated peptide antibody(ACPA).The patient’s medication was also recorded.The patients were followed up for any adverse drug reactions during the treatment period.Patients were compared for improvement at 4w,8w and 12 w of treatment and adverse effects were recorded.Results:(1)There were statistical differences(P<0.05)in ESR,CRP,RP,PLT,SJC,TJ C,DAS28,morning stiffness time,HAQ,CDAI,ACPA before and after treatment(before treatment,4 weeks of treatment,8 weeks of treatment,12 weeks of treatme nt);There was no statistically significant difference in globulin levels before and after treatment(pre-treatment,4 weeks of treatment,12 weeks of treatment)(P<0.05).(2)At 4w of treatment,patients showed the improvement of condition,and remission disease with a composition ratio of 23.33%(7/30);at 12 w of treatment,2cases were in moderate disease activity and the rest had achieved remission or low disease activity with a composition ratio of 93.33%(28/30);compared to pre-treatment,4w of treatment(Z=-3.491,P<0.05)and 12 w of treatment(Z=-6.704,P<0.05),the difference in patients disease activity composition ratio was statistically signifiant(P<0.05).(3)Medication use was recorded during follow-up and patients were found to be on a gradual reduction of oral prednisone and non-steroidal anti-inflammatory drugs(NSAIDs);prednisone was discontinued in 5 patients at 12 w,prednisone was reduced in 14 patients,NSAIDs were reduced in 14 patients,and oral NSAIDs were intermittently taken in 4 cases.(4)No serious adverse reactions such as leukopenia,significant elevation of liver enzymes and allergy occurred in all patients during treatment with iguratimod combination with tofacitinib.Conclusion:In patients with refractory moderate and severe RA,the therapy of tofacitinib combined with iguratimod can effectively relieve recently clinical symptoms and reduce inflammatory indicators,and is safe and reliable. |