【摘要】 目的:评价肿瘤坏死因子α拮抗剂阿达木单抗短期治疗类风湿关节炎(RA)的临床疗效及安全性,同时检测治疗前后类风湿因子(RF)和抗环瓜氨酸肽抗体(抗CCP抗体)滴度的变化,为RA疗效评估寻找新的指标。方法:随机双盲平行试验,纳入40例活动性RA患者,按2∶2∶1的比例被随机分配到试验组或对照组,试验组分为80 mg阿达木单抗+甲氨喋呤(MTX)、40 mg阿达木单抗+MTX两组,对照组为安慰剂+MTX。受试者隔周接受皮下注射阿达木单抗或同等体积的安慰剂,并在试验第0,2,4,8,12周随访,评价疗效及不良事件收集。疗效采用ACR核心标准评定。次要疗效指标包括压痛和肿胀关节数、晨僵时间、疼痛视觉模拟评分(VAS评分)、健康评估问卷(HAQ)和CRP。基线时及12周治疗结束后检测RF、抗CCP抗体。结果:试验组32例,对照组8例。12周后试验组患者ACR20、ACR50和ACR70缓解的比例都显著高于对照组(P<0.01);试验组患者关节触痛数、关节肿胀数、晨僵持续时间、疼痛VAS评分及健康状况问卷(HAQ)、CRP等次要疗效指标均较基线时水平明显降低(P<0.05);试验组RF血清滴度和抗CCP抗体均较基线时水平显著降低(P<0.05),而对照组没有观察到RF和CCP抗体滴度的显著改变。总体上来说阿达木单抗不良反应轻微,耐受性较好。结论:阿达木单抗+MTX治疗RA的疗效明显优于单用MTX组,能迅速改善各项症状、体征和实验室炎性指标。RF和抗CCP抗体滴度的检测对监测TNF-α拮抗剂治疗的RA患者临床进程及疗效是有用的指标。更多还原

【Abstract】 Objective: To evaluate the efficacy and safety of human monoclonal anti-TNF-α antibody(adalimumab) in patients with rheumatoid arthritis(RA),and to analyze the relationship between efficacy and the titers of rheumatoid factor(RF) and anti-cyclic citrullinated peptide(anti-CCP) autoantibodies.Methods: In a double-blind,placebo-controlled prospective study,40 patients with active RA were enrolled and randomized to 3 groups.They were treated with 40 mg(n=16) or 80 mg adalimumab(n=16) in addition to a background treatment(stable doses of methotrexate),or with placebo+background treatment(n=8).Symptom improvements and adverse reactions were assessed at weeks 0,2,4,8 and 12.Serum RF and anti-CCP autoantibodies were detected at baseline and at 12 weeks of follow-up.Results: The proportion of achieving American College of Rheumatology(ACR) 20,50,and 70 response criteria were significant higher in adalimumab groups than in placebo group(P<0.01).Tender joint count,swollen joint count,duration of morning stiffness,VAS score,HAQ and CRP were significantly decreased 12 weeks after adalimumab treatment(P<0.05).Adalimumab induced a significant decrease in serum levels of RF and anti-CCP(P<0.05),and the decrease in antibody titers was not seen in placebo group.The titers correlated with the clinical response to the therapy.Adalimumab was well-tolerated;adverse effects were little and light.Conclusion: Treatment with adalimumab plus methotrexate is more effective than methotrexate alone in active RA patients;the onset of effect is rapid.The titers of RF and anti-CCP autoantibodies may be potentially useful indicators to assess the effect of anti-TNF-α treatment in RA patients.更多还原