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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。
Objective To study the clinical efficacy and immunological effects of recombinant human TNF-α receptor-Fc fusion protein in the treatment of juvenile idiopathic arthritis (JIA). Methods From April 2011 to August 2013, 52 children with non-systemic JIA hospitalized in Wuhan Children’s Hospital were divided into treatment group (32 cases) and control group (20 cases). The treatment group was subcutaneously injected with recombinant human TNF receptor-Fc fusion protein, methotrexate (MTX) and non-steroidal anti-inflammatory drugs (NSAIDs). The control group received oral MTX and NSAIDs simultaneously. One, three and six months after treatment, the ACR Pedi score was used to evaluate the curative effect. Radiographic changes and changes in immunological parameters were compared. Side effects are also recorded. Results The ACR Pedi 30 at 1 month after treatment in the treatment group was significantly higher than the control group (P <0.05) at 3 months and 6 months after treatment. The CRP and ESR of the treatment group at one, three and six months after treatment were significantly lower than those before treatment (P <0.05). The levels of CD4, CD4 / CD8, TNF-α, 3 (MMP-3), Ig G, Ig M and Ig A were lower than those before treatment and control group (P <0.05). The expressions of CD8, CD16CD56, CD4 CD25, IL-10 and TGF- (P <0.05). The Poznanski value at 6 months after treatment was significantly improved compared with that before treatment (P <0.05). The CRP and ESR of the treatment group at 1 month and 3 months after treatment were significantly lower than those of the control group (P <0.05). The CRP of the treatment group at 6 months after treatment was significantly lower than that of the control group (P <0.05) Light (P <0.05). Six months after treatment, CD4CD25, IL-10 and TGF-β in treatment group were significantly higher than those in control group (P <0.05). Conclusion The recombinant human TNF-α Fc receptor-Fc fusion protein combined with traditional medicine has good safety and efficacy in the treatment of non-systemic JIA. The clinical efficacy is better than pure traditional treatment, which can reduce the inflammatory index more quickly and effectively. Can reduce radiological changes, significantly improve JIA cell and humoral immune disorders.