重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白治疗幼年特发性关节炎二年临床随访观察研究  

A 2-year follow-up study on the recombinant human tumor necrosis factor receptor-Fc fusion protein treatment of juvenile idiopathic arthritis

作　　者：曾萍 谢颖 唐盈 李丰 孙广超 杨艳红 曾华松 

机构地区：[1]广州市妇女儿童医疗中心广州市儿童医院风湿免疫科,510120

出　　处：《中华风湿病学杂志》2014年第2期95-99,共5页Chinese Journal of Rheumatology

基　　金：国家人事部留学归国人员基金（200499）;广东省自然科学基金（9151026003000004）

摘　　要：【摘要】目的对接受重组人Ⅱ型肿瘤坏死因子受体一抗体融合蛋白（rhTNFR：Fc）治疗的幼年特发性关节炎（JIA）患儿进行2年的临床观察随访，探讨rhTNFR：Fc的远期疗效、安全性及影响治疗效果的相关因素。方法57例接受rhTNFR：Fc治疗的JIA患儿进行了为期2年的临床随访，包括发病的年龄、时间，开始接受rhTNFR：Fc治疗的时间，疾病活动度的判断，治疗前的用药，治疗后每3个月进行随访登记1次，包括疾病活动度的评估，药物运用的剂量，感染或任何不良反应的发生。采用Pearson，检验，Logistic回归模型进行统计学分析。结果①22例患儿在医生的指导下，完成2年rhTNFR：Fc治疗观察，并在逐渐撤药过程中，其中8例达ACRPedi50．14例达ACRPedi70，纳入临床治疗有效组；35例患儿因病情好转或变化，治疗疗程不满2年，其中7例因病情好转，持续评估达ACRPedi70，在医生指导下撤药成功，继续其他DMARDs用药维持治疗，病情稳定，纳入治疗有效组；19例因临床评估无效（不达ACRPedi30），在医生指导下停药，纳入治疗无效组；7例失访患儿。②全身型JIA患儿rhTNFR：Fc治疗2年有效率（达ACRPedi50，70）为33％；少关节炎型有效率60％；多关节炎型有效率79％；治疗有效和无效2组患儿的临床特点统计分析显示，JIA不同分型和RF阳性率的情况在rhTNFR：Fc治疗有效组和无效组中的比例差异有统计学意义（矿=31．6，P〈O．05；5．488，P〈O．05），其余年龄、病程、性别、AKA阳性率、抗CCP抗体阳性率、ANA阳性率在2组中差异无统计学意义（P〉0．05）。③二分类Logistic回归分析显示JIA分型和RF与rhTNFR：Fc的疗效相关；JIA分型的相对危险度OR值为2．983（P〈O．05）；RF阳性率与疗效评估呈反向变化，RF阴性是治疗效果的保护因素，OR值为0．029（P〈0．05）。④8例患儿（2％）在治疗过程中出Objective To analyze the outcome of children with juvenile idiopathic arthritis （JIA） treated with recombinant human tumor necrosis factor receptor antibody fusion protein （rhTNFR： Fc） for 2 years, and to evaluate the long-term efficacy and safety as well as the related factors that affect the curative effect of rhTNFR：Fc. Methods Fifty-seven JIA patients treated with rhTNFR： Fc were followed up for 2 years. Clinical data were registered including age of onset, disease duration before rhTNFR： Fc treatment,disease activity assessment, medication before treatment, dosage regimen of infection or adverse reactions. Pearson Chi-Square statistical test and Logistic regression model of binomial classification were used for statistical analysis. Results 1 Twenty-two JIA cases completed 2-year therapy. Some were in the process of dosage tapering. Eight cases reached ACR Pedi 50, 14 cases reached ACR Pedi 70. All of them were included in the clinical effectiveness analysis. Thirty-five cases withdrawal in 2 years because of disease remission or treatment failure or side effects or infection. Seven who withdrew and then maintained with DMARDs under the supervision of doctors were evaluated by assessment of ACR Pedi 70. They were stable at the end of 2 years, and were included for the clinical effectiveness analysis group. Nineteen cases were withdrew by the doctor because they failed to reach ACR Pedi 30 within 3 months. They were included in the treatment failure analysis. Seven cases were lost during the tbllow up. 2 The remission rate （ ACR Pedi 50, 70） of SO-JIA in 2 years was 33%. Oligoarthritis rate was 60%, while that of polyarthritis rate was 79%. The statistical analysis showed that different categories and RF level were significantly different in effectiveness and treatment failure X2=31.6, P〈0.05; X2=5.488, P〈0.05）. There was no significant difference in age, sex, duration before treatment, AKA, CCP, ANA between the two groups （P〉0.05）. 3 Logistic regression analysis showed that di

关 键 词：关节炎 幼年型类风湿 随访研究 rhTNFR FC 

分 类 号：R725.9[医药卫生—儿科]