CAJ | 학술논문

目的评价甲氨蝶呤(MTX)联合环磷酰胺(CTX)及单独应用MTX、单独应用CTX治疗类风湿关节炎(RA)的疗效和安全性.方法本研究为随机、单盲、对照的临床试验.符合纳入及排除标准的RA患者随机分为单用MTX(10～15 mg/周)、单用CTX(400 mg/2～3周)及MTX联合CTX治疗组(MTX10～15 mg/周+CTX 400 mg/2～3周).疗程24周,在基线、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ACR20为主要疗效指标,ACR50、ACR70、欧洲抗风湿联盟(EULAR)疗效指标、疼痛目视模拟测试表(VAS)评分、患者对自身健康状况的总体评估(PGA)、医生总体评价、压痛关节数(TJC)、压痛关节指数(TJI)、肿胀关节数(SJC)、肿胀关节指数(SJI)、健康评估问卷(HAQ)为次要疗效指标.结果在第24周,MTX+CTX组达ACR20改善的患者比例(81%)高于MTX组(56%)及CTX组(35%),差异有统计学意义(P＜0.05).24周时MTX+CTX组达ACR50改善的患者比例高于CTX组(P＜0.05).与MTX组之间差异无统计学意义(P＞0.05).在第24周,MTX+CTX组达到EULAR有效的患者比例(77%)高于MTX组(48%)及CTX组(35%),差异有统计学意义(P＜0.05).24周时MTX+CTX组在TJC/TJI、SJC/SJI疼痛VAS评分、ESR的改善程度高于MTX组(P＜0.05).在压痛关节数脂数、肿胀关节数/指数、疼痛VAS评分、PGA、医生总体评价、HAQ、ESR的改善程度高于CTX组(P＜0.05).3组之间不良反应发生率差异无统计学意义.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MTX及单用CTX.两者联合治疗安全耐受性好,与单用MTX及单用CTX相比,并不增加不良反应的发生率.
목적 평개갑안접령(MTX)연합배린선알(CTX)급단독응용MTX、단독응용CTX치료류풍습관절염(RA)적료효화안전성.방법 본연구위수궤、단맹、대조적림상시험.부합납입급배제표준적RA환자수궤분위단용MTX(10～15 mg/주)、단용CTX(400 mg/2～3주)급MTX연합CTX치료조(MTX10～15 mg/주+CTX 400 mg/2～3주).료정24주,재기선、6、12、24주진행료효급안전성평고.이미국풍습병학회(ACR)료효평개지표ACR20위주요료효지표,ACR50、ACR70、구주항풍습련맹(EULAR)료효지표、동통목시모의측시표(VAS)평분、환자대자신건강상황적총체평고(PGA)、의생총체평개、압통관절수(TJC)、압통관절지수(TJI)、종창관절수(SJC)、종창관절지수(SJI)、건강평고문권(HAQ)위차요료효지표.결과 재제24주,MTX+CTX조체ACR20개선적환자비례(81%)고우MTX조(56%)급CTX조(35%),차이유통계학의의(P＜0.05).24주시MTX+CTX조체ACR50개선적환자비례고우CTX조(P＜0.05).여MTX조지간차이무통계학의의(P＞0.05).재제24주,MTX+CTX조체도EULAR유효적환자비례(77%)고우MTX조(48%)급CTX조(35%),차이유통계학의의(P＜0.05).24주시MTX+CTX조재TJC/TJI、SJC/SJI동통VAS평분、ESR적개선정도고우MTX조(P＜0.05).재압통관절수지수、종창관절수/지수、동통VAS평분、PGA、의생총체평개、HAQ、ESR적개선정도고우CTX조(P＜0.05).3조지간불량반응발생솔차이무통계학의의.결론 MTX연합CTX치료능현저개선RA적증상、체정화실험실염성지표,료효우우단용MTX급단용CTX.량자연합치료안전내수성호,여단용MTX급단용CTX상비,병불증가불량반응적발생솔.
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.