A Comparative Study Of Efficacy And Safety Of Iguratimod Combined With Methotrexate And Monotherapy For Rheumatoid Arthritis

Objective:To compare the efficacy and safety of the Iguratimod alone,methotrexate alone,and combination therapy of iguratimod and methotrexate in patients with rheumatoid arthritis,and to evaluate the efficacy and safety of the combination therapy.Methods:Participants who met the inclusion criteria accepted by the Rheumatology and Immunology Division of Tai’an Central Hospital and Feicheng People’s Hospital from January 2016 to December 2016 were randomly divided into the Iguratimod group and methotrexate group and combination treatment group.At the time of screening for the subjects,at the 4th,12 th,and 24 th weeks after the start of treatment,the number of tender joints,swollen joints,C-reactive protein,erythrocyte sedimentation rate,rheumatoid factor,and anti-loop were collected.Citrulline polypeptide antibody,immunoglobulin G,immunoglobulin M,immunoglobulin A,pain visual analog score,overall patient visual analog score,physician overall visual analogue scale,DAS28-ESR,DAS28-CRP,morning stiffness time,HAQ and other efficacy indicators,and calculate the differences between the indicators and baseline levels,and then analyze the differences between groups.Before and after treatment,blood group and blood biochemical safety indicators were collected for each group of subjects to compare the incidence of adverse reactions before each group.Results:At the 4th week after the start of treatment,the rate of erythrocyte sedimentation in the iguratimod combined with methotrexate group subjects(35.66±25.71 vs 63.38±31.77;P<0.01),anti-cyclic citrullin polypeptide antibody(27.7± 7.6 vs 32.6±8.6;P<0.05)and DAS28-ESR(6.48±0.45 vs 6.68±0.32;P<0.05)were all significantly lower than that of methotrexate group;the rate of erythrocyte sedimentation(47.69±28.78 vs 63.38;P<0.05)and DAS28-ESR(6.51±0.29 vs 6.68±0.32;P<0.05)of the iguratimod group were significantly lower than that of methotrexate group.The number of swollen joints in the iguratimod combined methotrexate group(5.62 ± 1.21 vs 5.01 ± 1.07,P<0.05),C-reactive protein(35.48±14.53 vs 22.22±9.84,P<0.01),erythrocyte sedimentation rate(42.58±19.85 vs 18.15±9.12,P<0.01,Rheumatoid factor(13.7 ± 7.2 vs 10.0 ± 6.5,P <0.05),Anti-cyclic citrullin polypeptide antibody(10.2±5.4 vs 3.9±1.7,P<0.01),Immunoglobulin Protein G(17.8 ± 6.2 vs 2.7 ± 1.9,P<0.01),Immunoglobulin A(3.7±2.4 vs 2.3±1.9,P<0.05),DAS28-ESR(1.16±0.21 vs 1.06±0.17,P<0.05)The decrease of DAS28-CRP(1.28± 0.46 vs 1.06±0.25,P<0.05)and other indicators were significantly greater than that of the methotrexate group.At the 12 th week after the start of treatment,except for immunoglobulin G,immuneoglobulin M,and immunoglobulin A,the difference between the other indicators and indexes of the iguratimod combined methotrexate group and the baseline level was significantly better than that of methylamine group(P<0.05 or P<0.01).Compared with the Iguratimod group,except for the number of tender joints,number of swollen joints,rheumatoid factor,immunoglobulin G,immunoglobulin M,immunoglobulin A,morning freezing time and morning freezing time,and the difference between baseline levels In addition,other indicators of the iguratimod combined methotrexate group were lower than the iguratimod group,and the difference between the index and the baseline level was greater than that of the iguratimod group(P<0.05 or P<0.01).The number of swollen joints,C-reactive protein,erythrocyte sedimentation rate,anti-cyclic citrullinated peptide antibody,patient’s overall visual analog score,physician’s visual analog scale,DAS28-ESR,and DAS28-CRP were significantly lower in the IGU group than in the MTX group(P<0.05 or P<0.01).At the 24 th week after the start of treatment,except for immunoglobulin G,immuneoglobulin M,and immunoglobulin A,the difference between other indicators and indicators of the iguratimod combined methotrexate group and the baseline level was significantly better than that of methylamine The pterin group(P<0.05 or P<0.01).Comp-ared with the iguratimod group,except for morning stiffness,morning stiffness and baseline differences and other indicators of the iguratimod combined with methotrexate were lower than Ira In the Mod group,the difference between the index and the baseline was greater than that in the Iguratimod group(P<0.05 or P<0.01).The number of tender joints,the number of swollen joints,C-reactive protein,erythrocyte sedimentation rate,pain visual analogue scale,overall visual analog scale of patients,overall visual analog scale of physicians,DAS28-ESR,DAS28-CRP,and HAQ were significantly lower in the IGU group than in the MTX group.The incidence of liver injury and gastrointestinal adverse reactions was significantly higher in the methotrexate group than in the ilamidine group(P<0.05 or P<0.01).Conclusion:The results of this study indicate that the combination of iguratimod and methotrexate for rheumatoid arthritis has significant therapeutic advantages over iguratid and methotrexate alone.Adverse reactions rates were also lower than methotrexate alone.Therefore,the combination of Iguratimod and methotrexate is recommended for the treatment of rheumatoid arthritis.