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研究

Clinical Study of the Treatment of Ankylosing Spondylitis by Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ:IgG Fc Fusion Protein

目的评价重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白益赛普治疗强直性脊柱炎的疗效和安全性。方法应用益赛普治疗6例诊断为强直性脊柱炎的患者,剂量为50mg/次,皮下注射,每周1次,总疗程为12周,治疗前后对每位患者进行临床症状和体征以及实验室检查的评估。结果益赛普治疗后,BASDAI、BASFI、脊柱痛与夜间痛症状以及指地距与治疗前相比具有统计学意义(P<0.05)。益赛普治疗后,患者的ESR和CRP这两项炎性指标较前均显著下降,其结果具有统计学意义(P<0.05),治疗期间未出现严重不良反应。结论益赛普治疗强直性脊柱炎有显著疗效。

Objective To investigate the efficacy and safety of etanercept, a recombinant human tumor necrosis factor-α reeceptor Ⅱ ： IgG Fc fusion protein in the treatment of ankylosing spondyLitis Methods Six patients with ankylosing spondylitis received etanercept 50mg once a week for the treatment course of 12 weeks. The evaluation of clinical symptoms and signs and laboratory tests were taken before and after the treatment Results BASDAI, BASFI, degree of back pain and pain at night, finger to floor distance were significantly improved after treatment （ P 〈0.05 ） . ESR and CRP were also significantly reduced after treatment （ P 〈0.05 ） . No adverse event was observed during treatment Conclusion Etanercept has an obvious therapeutic effect on ankylosing spondylitis without serious adverse effects.