强克治疗幼年特发性关节炎48例对照观察

Efficacy and safety of recombinant human TNF receptor-Ig fusion protein for injection as the first and second biologic agent in juvenile idiopathic arthritis

目的:探讨注射用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白(强克)治疗幼年特发性关节炎的疗效和安全性。方法:将48例幼年特发性关节炎患儿分为两组,观察组26例仅使用强克进行治疗,对照组22例给予口服非甾体类抗炎药+改善病情的抗风湿药,依照美国风湿病学会ACR Pedi 30、50、70、90分标准评估疗效;并且评估不良事件和安全性。结果:治疗后第12个月,对照组有63.4%的患者达到ACR Pedi 30分。61.0%的患者达到ACR Pedi 50分,44.3%的患者达到ACR Pedi 70分,30.2%的患者达到ACR Pedi 90分。观察组72.6%的患者达到ACR Pedi 30分,63.2%的患者达到ACR Pedi 50分,48.8%的患者达到ACR Pedi 70分,34.2%的患者达到ACR Pedi 90分。观察组发生不良反应4例,严重不良反应1例;无恶性肿瘤,无机会性感染,无脱髓鞘疾病,无红斑反应。结论:强克治疗幼年特发性关节炎疗效显著,优于传统药物治疗,不良反应发生率低,安全性好。

Objective：To evaluate the efficacy and safety of recombinant human TNF receptor-Ig fusion protein for injection in patients with juvenile idiopathic arthritis（JIA）.Methods：Baseline demographic and clinical characteristics and disease activity parameters were prospectively documented.Efficacy was determined using the American college of rheumatology ACR Pedi response criteria.Safety assessments were based on adverse event reports from the responsible physician.Results：ACR Pedi 30,50,70,and 90 scores were achieved in 63.4%,61.0%,44.3%,and 30.2% of biologics naive patients,respectively,at12 months of treatment,while ACR Pedi 30,50,70,and 90 scores were achieved in 72.6%,63.2%,48.8% and 34.2% of biologic-switcher patients,respectively.No malignancies were observed during adalimumab exposure.Conclusion：Recombinant human TNF receptor-Ig fusion protein for injection appears to be highly effective in children and adolescents with JIA who have been previously treated with biologic agents and in children and adolescents who switched biologic agents.The treatment is safe and its efficacy is similar to that of other biologic agents used to treat JIA.Few patients discontinued therapy due to intolerance or inefficacy.