RESUMO
Objective To evaluate the clinical efficacy and safety of methotrexate(MTX),cyclophosphamide(CTX)and MTX plus CTX in patients with active rheumatoid arthritis(RA).Methods In a randomized,single-blinded,controlled study,90 patients were randomly assigned to receive MTX(10～15 mg/w)or CTX(400 mg/2～3 w)or MTX plus CTX(MTX 10～15 mg/w+CTX 400 mg/2～3 w).The primary end point was the proportion of patients meeting the American College of Rheumatology 20% improvement criteria(achieving an ACR20 response,)at week 24.The secondary end points were responses of the ACR50 and ACR70 improvement criteria,and the European League Against Rheumatism(EULAR)response criteria.The change from baseline in duration of pain,patient's global assessment,physician's global assessment,tender joint count/index,swollen joint count/index,health assessment questionnaire(HAQ),erythrocyte sedimentation rate(ESR)were also evaluated.The clinical efficacy and safety were analyzed at baseline,6,12 and 24 weeks respectively.Results The ACR response rate was significantly higher in the MTX plus CTX treatment group compared with MTX or CTX group at week 24.The MTX plus CTX group,MTX group and CTX group showed 81%,56% and 35% in ACR20,58%,41% and 12% in ACR50 and 19%,11% and 0 in ACR70,.respectively.At week 24,the proportion of patients achieving the EULAR moderate response in those who received combination treatment were significantly higher than those who received either MTX or CTX.The incidence of adverse events(AEs)was not significantly higher in MTX plus CTX group than MTX or CTX group.Conclusion MTX plus CTX effectively reduces the signs and symptoms of RA and is generally well tolerated by patients without significant increase in the rate of adverse events compared with monotherapy.
