【摘要】 目的研究重组人Ⅱ型肿瘤坏死因子(TNF)受体-抗体Fc融合蛋白治疗幼年特发性关节炎(JIA)的临床疗效及免疫学效应。方法 2011年4月至2013年8月武汉市儿童医院住院的52例非全身型JIA患儿分为治疗组32例和对照组20例。治疗组皮下注射重组人Ⅱ型TNF受体-抗体Fc融合蛋白,同时合并使用甲氨蝶呤(MTX)及非甾体类抗炎药(NSAID);对照组口服MTX,同时合并使用NSAID。治疗后1、3、6个月采用ACR Pedi评分进行疗效评估,比较放射学改变及免疫学指标改变情况。同时记录副反应。结果治疗组治疗后1个月ACR Pedi 30,治疗后3个月、6个月ACR Pedi 30、50、70达标率均显著高于对照组(P<0.05)。治疗组治疗后1个月、3个月、6个月的CRP、ESR均较治疗前明显降低(P<0.05);治疗后6个月的CD4、CD4/CD8、TNF-α、基质溶解素3(MMP-3)、Ig G、Ig M、Ig A较治疗前及对照组均降低(P<0.05);CD8、CD16CD56、CD4CD25、IL-10、转化生长因子-β(TGF-β)则较治疗前升高(P<0.05);治疗后6个月的Poznanski值较治疗前明显改善(P<0.05)。治疗后1个月、3个月治疗组CRP、ESR较对照组明显降低(P<0.05),治疗后6个月治疗组CRP较对照组明显降低(P<0.05),放射学改变较对照组轻(P<0.05)。治疗后6个月治疗组,CD4CD25、IL-10、TGF-β较对照组升高(P<0.05)。结论重组人Ⅱ型TNF受体-抗体Fc融合蛋白联合传统药物治疗非全身型JIA具有良好的安全性和有效性,临床疗效优于单纯传统治疗,能更快、更有效降低炎性指标,并能减轻放射学改变,明显改善JIA细胞及体液免疫紊乱。更多还原

【Abstract】 Objective To evaluate the clinical and immunologic effectiveness of recombinant human necrosis factor receptor type Ⅱ-Fc fusion protein antibody(rh TNFR:Fc)in the treatment of juvenile idiopathic arthritis. Methods Fifty-two non-systemic JIA subjects were included into this study. All JIA patients were divided into treatment and control groups randomly. The treatment group consisted of thirty-two patients on a regimen of rh TNFR:Fc subcutaneously injected,permitting to combine NSAID and MTX. The control group contained twenty patients on a regimen of MTX orally taken,permitting to combine NSAID. Follow-up was conducted at baseline,1 month,3 months and 6 months after treatment. Clinical efficacy was evaluated based on ACR Pedi 30/50/70 score. The changes of radiographic progression and changes of immunological indexes after treatment were compared. Side effects were recorded. Results In the treatment group,at 1 month after treatment,the ACR Pedi 30 compliance rate was higher than that in the control group(P<0.05).At 3 months and 6 months,the ACR Pedi 30/50/70 compliance rates were higher than those in the control group(all P<0.05).In the treatment group,at 1 month,3 months and 6 months after treatment,the values of CRP and ESR were lower than pretherapy(all P<0.05). At 6 months after treatment,the values of CD4,CD4/CD8,TNF-α,MMP-3,Ig G,Ig M and Ig A were lower than pretherapy(all P<0.05),while the values of CD8,CD16CD56,CD4CD25,IL-10 and TGF-β were higher than pretherapy(all P<0.05);the value of Poznanski was ameliorated than pretherapy(P<0.05).In the treatment group,at 1 month and 3 months after treatment,the values of CRP and ESR were lower than those in the control group(all P<0.05). At 6 months,the value of CRP was lower than that in the control group(P<0.05);the radiographic damage was slighter than that in the control group(P<0.05);the values of CD4,CD4/CD8,TNF-α,MMP-3,Ig G,Ig M and Ig A were lower than those in the control group(all P<0.05),while the values of CD4CD25,IL-10 and TGF-β were higher than those in the control group(all P<0.05). Conclusion Recombinant human necrosis factor receptor type Ⅱ-Fc fusion protein antibody is safe and has a favorable effect in the treatment for non-systemic JIA. The clinical efficacy is superior to traditional therapy,and the inflammatory indexes decrease faster and more effective,meanwhile,it can ameliorate the radiographic progression and obviously improve the cell and humoral immunity disorder in JIA.更多还原