重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白治疗强直性脊柱炎的临床观察

Clinical observation of recombinant human type Ⅱ tumor necrosis factor receptor-antibody fusion protein in the treatment of ankylosing spondylitis

目的:评价重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白治疗强直性脊柱炎的临床疗效和安全性。方法:选取2007年1月-2011年12月,本科收治的强直性脊柱炎活动性患者56例,随机分为治疗组与对照组,每组28例患者。治疗组患者予以依那西普(50mg,1次/周皮下注射)治疗;对照组患者给予甲氨蝶呤(10～15mg/周)和柳氮磺吡啶(1.5～2.0g/d)联合治疗,两组均同时给予非甾体类抗炎药(NSAIDs)治疗。疗程12周后评价腰痛发生率、腰部晨僵时间、实验室炎症反应指标:红细胞沉降率(ESR)和C反应蛋白(CRP)、血小板计数(PLT)及BASDAI、BASFI评分等,随时记录观察期间不良事件。结果:两组治疗12周后与各自基线相比,腰痛发生率明显降低(P<0.05),腰部晨僵时间明显缩短(P<0.05),BASDAI、BASFI评分明显改善,ESR、CRP、PLT明显降低(P<0.05);治疗组各项临床指标改善程度均明显优于对照组(P<0.05);两组患者不良反应发生率比较差异无统计学意义(P>0.05)。随访过程中,治疗组患者降低依那西普用药频率继续使用,病情维持稳定。不良反应均为轻度,未发现结核、病毒性肝炎感染等情况。结论:依那西普治疗强直性脊柱炎的临床疗效显著,且安全性较高。

Objective： To evaluate the clinical efficacy and safety of recombinant human type II tumor necrosis factor receptor-antibody fusion protein （etanercept） in the treatment of ankylosing spondylitis. Methods： Fifty-six patients with ankylosing spondylitis hospitalized in our department from January 2007 to December 2011 were randomly divided into either a treatment group or a control one with 28 patients each. The patients in the treatment group were subcutaneously injected 50 mg of etanercept once a week while the patients in the control group were administrated with methotrexate （10-15 mg/week） and sulfasalazine （1.5-2.0 g/d）. Besides, all patients had the addition of non-steroidal anti-inflammatory drugs （NSAIDs）. The incidence of lumbago, duration of morning stiffness of waist, inflammatory markers and so on were evaluated at baseline after 12 week treatment and the adverse events were recorded during the observation period. Results： The improvement of clinical indicators was significantly better in the treatment group than in the control group （P〈0.05）. The incidence of adverse reactions in two groups showed no significant difference （P〈0.05）. Conclusion： Etanercept is safe and effective in the treatment of ankylosing spondylitis.