英夫利昔单抗治疗幼年特发性关节炎的疗效

Clinical study of infliximab in treatment of patients with juvenile idiopathic arthritis

目的研究英夫利昔单抗治疗幼年特发性关节炎（JIA）患儿的临床疗效、不良反应及转归。方法32例英夫利昔单抗组JIA患儿于0、2、6、ld、22、30周静脉输注英夫利昔单抗3～8mg／（kg·次），按治疗剂量不同分为≥5mg／（kg·次）大剂量治疗组和〈5mg／（kg·次）小剂量治疗组。比较英夫利昔单抗组和30例JIA常规治疗（对照组）患儿压痛关节数（TJC）、肿胀关节数（SJC）、红细胞沉降率（ESR）、C-反应蛋白（CRP）、患者自身综合评分（GH）、疾病活动度评分（DAS）28评分和不良反应，分析英夫利昔单抗的疗效、不良反应和预后。结果英夫利昔单抗治疗可改善JIA患儿TJC、SJC、ESR、GH、CRP和DAS28评分。英夫利昔单抗组JIA患儿的SJC在2周最先开始下降，6周时TJC、ESR、GH和DAS28评分开始下降，TJC、SJC、ESR、CRP和DAS28评分持续下降至22周无进行性下降，GH持续下降至30周。英夫利昔单抗大剂量治疗组患儿ESR、GH和CRP均低于小剂量治疗组（t=2．14、3．04、2．33，P=0．04、0．01、0．04），2组TJC、SJC、DAS28评分和近期不良反应发生率比较差异无统计学意义。英夫利昔单抗组2例（6．25％）患儿治疗失败，9例（28．13％）患儿持续英夫利昔单抗治疗达46～62周，7例（21．88％）患儿于30周后停用英夫利昔单抗且关节及炎症反应控制良好，14例（43．75％）患儿停用英夫利昔单抗后病情加重，重新开始治疗；1例患儿在停用英夫利昔单抗后发生重症水痘感染，死亡。结论英夫利昔单抗治疗能改善JIA患儿关节症状、炎症指标和DAS28评分，是近期安全、有效的JIA治疗手段。

Objective To explore the clinical efficacy, adverse effect and prognosis of infliximab in treatment of the patients with juvenile idiopathic arthritis （JIA）. Methods Thirty-two cases of infliximab-treated JIA patients and 30 cases of JIA control patients were investigated in this prospective study, and their tender joint count （TJC） , swollen joint count （SJC）,erythrocyte sedimentation rate （ESR）,C-reactive protein （CRP）,visual analog scale for general health （ GH）, disease activity score （DAS） 28, as well as adverse reactions of treatment and follow-up outcomes were analyzed. The infliximab-treated patients were intravenously infused with infliximab at the low dose of 〈 5 mg/ （kg·time） or the high dose of ≥5 mg/（ kg·time） in 0,2nd ,6th ,14th ,22nd ,30th week. The JIA control patients were treated wilh conventional therapy. Results The treatment of infliximab ameliorated the TJC, SJC, ESR, GH, CRP and DAS28 of JIA patients. In the dynamical analysis of these clinical indexes of the infliximab-treated JIA patients,the in- dex of SJC was found to fall firstly in the 2nd week,the indexes of TJC,ESR,GH and DAS28 were found to decline se- condly at 6th week, the indexes of TJC, SJC, ESR, CRP and DAS28 continued dropping till 22nd week, and only the index of GH progressively declined to 30th week. The high-dose infliximab-treated group had lower levels of ESR, GH and CRP than the low-dose infliximab-treated group （t = 2. 14,3.04,2. 33, P = 0. 04,0. 01,0. 04 ）. But there were no statistical difference in TJC,SJC, DAS28 and the incidence of recent adverse reactions between the high and low infliximab dose groups. In the infliximab treated group,2 cases of patients （6.25%） failed in the therapy of infliximab;9 cases of pa- tients （28.13%） continued therapy with infliximab to 46th -62nd week; 7 cases of patients （21.88%） stopped thera- py with infliximab in the 30th week had good improvement of joint symptoms and inflammatory indexes;14 cases of pa- tients （43.75%） relapsed and retreated by infliximab after cease the first course of treatment ; 1 case of patient died of severe chickenpox infection after therapy with infliximab was ceased. Conclusions Infliximab can alleviate the joint symptoms,inflammatory indexes and DAS28 of JIA patients,and is an effective and safe therapy for JIA patients in the short-term study.