摘要
目的评价甲氨蝶呤(MTX)联合环磷酰胺(CTX)治疗类风湿关节炎(RA)的疗效和安全性。方法将152例RA患者随机分为单用MTX组56例、单用CTX组40例及MTX联合CTX组56例,疗程24周,在0、6、12、24周进行疗效及安全性评估,以美国风湿病学会(ACR)疗效评价指标和欧洲抗风湿病联盟(EULAR)疗效指标等进行疗效评价。结果在24周,联合组达ACR20改善的患者为42例(81%),高于MTX组30例(56%)(30/54)及CTX组12例(35%)(12/54),差异有统计学意义(P<0.05);联合组达ACR50改善的患者为22例(41%),高于CTX组4例12%(4/34)(,P<0.05),与MTX组22例(41%)(22/54)之间差异无统计学意义(P>0.05)。结论 MTX联合CTX治疗能显著改善RA的症状、体征和实验室炎性指标,疗效优于单用。
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 180 patients were randomly assigned to receive MTX（7.5mg/w） or CTX（400mg/2w） or MTX plus CTX（MTX 7.5mg/2＋CTX 400mg/2w）.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/indes,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 was not significantly higher in MTX plus CTX group than others.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.
出处
《中国医药指南》
2011年第8期15-16,共2页
Guide of China Medicine
关键词
关节炎
类风湿
甲氨蝶呤
环磷酰胺
Arthritis
rheumatoid
Methotrexate
Cyclophosphamide
