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的随机对照研究  

A randomized controlled study of juvenile idiopathic arthritis treated with recombinant human H tumor necrosis factor-Fe function protein

作　　者：曾萍 谢颖 唐盈 李丰 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过敏免疫风湿病科,510120

出　　处：《国际儿科学杂志》2012年第5期533-536,共4页International Journal of Pediatrics

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资助项目（9151026003000004）;广州市科信局资助项目（2012J4100031）

摘　　要：目的运用随机对照试验研究重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白（rhTNFR：Fc）治疗幼年特发性关节炎（JIA）患儿的疗效。方法运用随机对照原则，将124例JIA患儿分为对照组（62例）及治疗组（62例），两组基础治疗为应用一种以上抗风湿慢作用药物，或非甾体类药物，或肾上腺皮质激素；两组临床分型[其中少关节型17例（27．42％），多关节型15例（24．19％），全身型30例（48．38％）]及基础治疗差异无统计学意义（P〉0．05）。治疗组JIA患儿皮下注射rhTNFR：Fc每周0．8mg／kg，疗程6个月。两组于用药后2周、1个月、3个月、6个月记录评价指标：ACRPedi30、50、70和药物不良反应。结果治疗组不同分型的JIA患儿，用药后2周、1个月达ACRPedi30，3个月、6个月后达ACRPedi50，6月后达ACRPedi70的缓解率不同（P〈0．05）；全身型患儿的临床缓解率较少关节型和多关节型的低（P〈0．05），用药后3个月44％ACRPedi50缓解，用药后6个月41．7％ACRPedi50缓解，29．2％达ACRPedi70缓解；少关节型和多关节型患儿在不同时间点的ACRPedi30、50、70的缓解率差别不大，80％以上患儿在用药后6个月达ACRPedi50缓解，50％以上患儿达ACRPedi70缓解，与对照组比较差异有统计学意义（P〈0．05）。治疗组全身型患儿中，3例合并巨噬细胞活化综合征常规治疗无效的患儿使用rhTNFR：Fc后效果明显，2例患儿治疗1周后出现全身酸痛等不适，3例患儿在治疗期间多次出现上呼吸道感染、腹泻等感染症状，其中1例感染水痘，停药和对症治疗后好转。治疗组全身型患儿不良反应发生率为16．7％，少关节型和多关节型患儿未见不良反应发生。结论rhTNFR：Fc对少关节型和多关节型JIA患儿具有良好的治疗效果，中短期（6个月）内的不良反应少见；对全身型JIA有一定的临床缓解治疗作用，应用时须严加防�Objective Through the application of recombinant human Ⅱ tumor necrosis factor-Fc function protein （rhTNFR： Fc） in the treatment of juvenile idiopathic arthritis （JIA） with randomized control study, clinical characteristic and clinical effect were summarized. Methods According to the randomized controlled principle, 124 patients with JIA were divided into control group and treatment group. The basic treatment in two groups were one antirheumatic slow-acting drug, nonsteroidal drug, adrenal cortical hormone. There were no significant differences between clinical type and basic treatment in two groups （ P 〉 0. 05 ）. Sixty-two patients of JIA treated with rhTNFR： Fc by subcutaneous injection. The doses was 0. 8mg /kg per week. There were 17 cases of oligoarthritis, 15 cases of polyarthritis, 30 cases of systemic arthritis in the treat- ment group and control group respectively. The basic antirheumatic drugs, nonsteroidal anti-inflamatory drugs （NSAIDs）, adrenal cortex hormone were allowed to continued. Clinical evaluation index included ACR Pedi 30, ACR Pedi 50 and ACR Pedi 70. The adverse drug reactions were recorded. Results The remission rate of ACR Pedi 30, 50, 70 in 2 weeks, one month, three monthes and six monthes were different in types of JIA patients in the treatment group （ P 〈 0. 05 ）. The remission rate of systemic arthritis was lower than the oth- er two groups of arthritis （ P 〈 0. 05 ）. Only 44% ACR Pedi 50 remission was achieved after three monthes medication in systemic arthritis and 41.7% ACR Pedi 50, 29. 2% ACR Pedi 70 were achieved after six monthes. The remission rate in the types of oligoarthritis and polyarthritis at different time points （2 weeks,one month, three monthes, six monthes） of ACR Pedi 30, 50, 70 were similar. After six monthes, more than 80% reached ACR Pedi 50 remission, more than half of patients reached ACR Pedi 70 remission. Three cases of macrophage activation syndrome in systemic arthritis group was effective treated with rhTNFR： Fc.

关 键 词：重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白 幼年特发性关节炎 随机对照研究 

分 类 号：R725.9[医药卫生—儿科]