依那西普治疗难治性类风湿关节炎临床观察

Efficacy of etanercept in the treatment of refractory rheumatoid arthritis

目的:评价肿瘤坏死因子抑制剂(依那西普)治疗难治性类风湿关节炎(RA)的临床疗效和安全性。方法:75例难治性RA患者分为治疗组和对照组,治疗组40例,对照组35例。治疗组在每周口服甲氨蝶呤(MTX)15mg基础上联合应用依那西普,每周皮下注射2次,每次25mg;对照组口服相同剂量的MTX联合应用其他改变病情药(DMARDs),如柳氮磺胺吡啶或来氟米特。疗程均为12周。疗效采用美国风湿病学会(ACR)标准评定。结果:治疗6周后,治疗组和对照组的临床症状和实验室指标均有改善,ACR20%改善标准(ACR20)有效率分别为37.5%和17.1%(P<0.01),ACR50%改善标准(ACR50)有效率为17.5%和2.8%(P<0.01)。治疗12周后各项指标进一步改善,治疗组和对照组的ACR20有效率分别为65.0%和37.1%(P<0.01),ACR50有效率为47.5%和11.4%(P<0.01)。进一步比较两组治疗前后简明疾病活动评分(DAS28)的变化,发现治疗组患者DAS28下降更明显,治疗后两组DAS28差异有显著性(P<0.05)。治疗组最常见的不良反应主要是注射部位反应和上呼吸道感染。结论:依那西普是安全有效的治疗RA的药物,尤其适合对MTX等DMARDs疗效不佳的患者。

Objective To evaluate the efficacy and safety of the tumor necrosis factor-α （TNF-α） inhibitor etanercept in the treatment of patients with refractory rheumatoid arthritis（RRA）. Methods We retrospectively analyzed 75 cases of RA. In etanercept treatment group, 40 patients were treated with etanercept （25 mg, twice a week） combined with weekly oral methotrexate（MTX）（15mg per week） for 12 weeks. 35 patients receiving the same dosage MTX combined with salicylazosulfapyridine （SASP） or leflunomide for 12 weeks were observed as a control group. Clinical assessments used the American College of Rheumatology criteria （ACR）. Results All patients completed treatment. As compared with the control group, the etanercept treatment group had a more rapid improvement in ACR20 and ACR50 in disease activity during the first 6 weeks （37.5% vs 17.1%, 17.5% vs 2.8%, P 〈 0.01, respectively）. At the end of 12 week treatment, the etanercept treatment group also had significant improvement in ACR20 and ACR50 when compared with the control group （65.0% vs 37.1%, 47.5% vs 11.4%, P 〈 0.01, respectively）. Compared with the control group, the etanercept treatment group had a more obviously decrease of the DAS28 score, and there was also significant difference between the etanercept group and the control group after 12 weeks （P 〈 0.05）. The most common adverse events of etanercept included injection site reaction and upper respiratory infection in our study. Conclusion Etanercept is a safe and effective drug for RA patients, especially for the ones who have little reaction to the disease-modifying anti-rheumatic drugs as MTX.