甲氨蝶呤联合传统DMARDs与联合生物制剂治疗RA的疗效比较

Methotrexate Combined with Conventional DMARDs or Biological Agents for Rheumatoid Arthritis

目的比较甲氨蝶呤联合传统改善病情的抗风湿药(DMARDs)与联合生物制剂治疗类风湿关节炎(RA)的临床疗效。方法将单用甲氨蝶呤治疗3个月失败的46例RA患者按随机数字表法分为A组(21例)和B组(25例)。A组给予甲氨蝶呤片联合传统DMARDs(来氟米特片+羟氯喹片)治疗,B组给予甲氨蝶呤片联合生物制剂(注射用重组人Ⅱ型肿瘤坏死因子受体)治疗。观察2组治疗前和治疗3、6个月后晨僵持续时间,关节肿胀数、关节压痛数、静息痛次数,美国健康评估问卷(HAQ)评分、28个关节疾病活动度评分系统(DAS28)评分,患者对目前疾病总体状况的自我评价评分、医生对患者疾病总体状况的评分及实验室指标[(WBC)计数,血清丙氨酸氨基转移酶(ALT)、肌酐(Cr)、红细胞沉降率(ESR)、C-反应蛋白(CRP)]的变化。结果 2组治疗3个月后WBC计数,血清ALT、Cr、CRP水平与治疗6个月后比较差异无统计学意义(P>0.05)。与同组治疗3个月后比较,A、B 2组治疗6个月后晨僵持续时间缩短,关节肿胀数、关节压痛数、静息痛次数均明显减少,HAQ评分、DAS28评分、患者对目前疾病总体状况的自我评价评分、医生对患者疾病总体状况的评分及血清ESR水平均明显降低(均P<0.05);与A组比较,B组治疗3、6个月治疗后晨僵持续时间显著缩短,关节肿胀数、关节压痛数、静息痛次数均明显减少,HAQ评分、DAS28评分、患者对目前疾病总体状况的自我评价评分、医生对患者疾病总体状况的评分及血清ESR水平均明显降低(均P<0.05)。结论甲氨蝶呤联合传统DMARDs与联合生物制剂对单用甲氨蝶呤治疗3个月失败的患者均有效果,但甲氨蝶呤与联合生物制剂治疗效果更优于联合传统DMARDs。

Objective To compare the clinical effects of methotrexate(MTX)combined with traditional disease-modifying antirheumatic drugs(DMARDs)and MTX combined with biologic agents on rheumatoid arthritis(RA).Methods Forty-six RA patients failed to respond to the treatment with MTX alone for 3 months were randomly divided into two groups.The group A(21 cases)was given MTX tablets combined with DMARDs(leflunomide tablets+hydroxychloroquine tablets).The group B(25 cases)was treated with MTX combined with biologic agents(recombinant human typeⅡtumor necrosis factor receptor).Morning stiffness duration,swollen joint count,tender joint count,resting pain frequency,American health assessment questionnaire(HAQ)score,28-joint disease activity score(DAS28),patient’s self-evaluation score of overall condition,doctor’s rating score of patient’s overall condition,and laboratory indexes(white blood cell(WBC)count,alanine aminotransferase(ALT),creatinine(Cr),erythrocyte sedimentation rate(ESR)and C-reactive protein(CRP))were determined before and after treatment for 3 and 6 months.Results The WBC count and serum ALT,Cr and CRP levels measured after treatment for 3 months were not significantly different from those measured after treatment for 6 months in both groups(P>0.05).However,compared with those measured after treatment for 3 months,morning stiffness duration,swollen joint count,tender joint count,resting pain frequency,HAQ score,DAS28 score,patient’s self-evaluation score of overall condition,doctor’s rating score of patient’s overall condition,and serum ESR level obviously decreased after treatment for 6 months in both groups(P<0.05).Furthermore,these indexes significantly reduced in group B,compared with group A(P<0.05).Conclusion Both MTX combined with conventional DMARDs and MTX combined with biological agents are effective for RA in patients failed to respond to the treatment with MTX alone for 3 months,but the latter is more effective than the former.