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浙江大学学报（医学版）
浙江大学学报（医学版）  2017, Vol. 46 Issue (4): 421-426    DOI: 10.3785/j.issn.1008-9292.2017.08.12
原著     
人源化白细胞介素-6受体抗体治疗全身型幼年特发性关节炎的疗效及安全性
邹丽霞, 卢美萍, 郭莉, 滕丽萍, 徐益萍, 郑琪
浙江大学医学院附属儿童医院风湿免疫变态反应科, 浙江 杭州 310003
Efficacy and safety of humanized interleukin-6 receptor antibody in treatment of systemic juvenile idiopathic arthritis
ZOU Lixia, LU Meiping, GUO Li, TENG Liping, XU Yiping, ZHENG Qi
Department of Rheumatology, Immunology & Allergy, Children's Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China
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摘要：

目的：探讨人源化IL-6受体抗体（托珠单抗注射液）治疗全身型幼年特发性关节炎（sJIA）的临床疗效及安全性。方法：回顾性分析2015年12月-2016年11月在浙江大学医学院附属儿童医院应用托珠单抗治疗的13例sJIA患儿的临床资料，包括血常规、C反应蛋白（CRP）、红细胞沉降率（ESR）、IL-6、血清铁蛋白、美国风湿病学儿科（ACR Pedi）30/50/70/90评分、激素使用情况以及治疗期间的不良反应。结果：与治疗前比较，治疗后第3天患儿的CRP和ESR明显下降（均P<0.05）；治疗后第2周血红蛋白增加和血小板减少（均P<0.05）；第4周血清铁蛋白水平下降（P<0.05）；白细胞在治疗后第8周时减少（P<0.05）。IL-6水平在治疗后先上升，第4周时下降，但与治疗前比较差异均无统计学意义（均P>0.05）。治疗第4周ACR Pedi 30或以上达100%；第20周时，61.5%的患儿达到ACR Pedi 90和停用糖皮质激素。随访至20周，所有患儿共发生不良反应22例次，其中感染发生率占54.5%（12/22），无严重不良反应发生。结论：托珠单抗能快速控制sJIA炎症，改善疾病活动度，有助于糖皮质激素的顺利减量及停药，且安全有效。
关键词： 关节炎;  幼年型类风湿/药物疗法;  糖皮质激素类/治疗应用;  白细胞介素6;  抗体;  单克隆/治疗应用;  治疗结果;  安全性    
Abstract:

Objective:To evaluate the efficacy and safety of humanized anti-IL-6 receptor monoclonal antibody (tocilizumab) in treatment of systemic juvenile idiopathic arthritis (sJIA). Methods:Thirteen sJIA patients admitted between December 2015 and November 2016 and received tocilizumab treatment were enrolled in the study. The complete blood count (CBC), C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), interleukin-6 (IL-6) and ferritin levels were measured; American College of Rheumatology Pediatric(ACR Pedi)30/50/70/90 scores were assessed; and the use of glucocorticosteroid and adverse events were documented. Results:Compared with the baseline levels, the CRP and ESR at d3 were decreased (all P<0.05); hemoglobin was increased and platelet was decreased at week 2 (all P<0.05), ferritin decreased at week 4, white blood cell (WBC) decreased at week 8 after treatment with tocilizumab (all P<0.05). The level of IL-6 was rising at d3 and week 2 and descending at week 4, but no significant difference was observed compared with the baseline level (all P>0.05). All 13 patients achieved ACR Pedi 30 remission at week 4, 61.5% achieved ACR Pedi 90 remission and glucocorticosteroids were withdrawn at week 20. Twenty two adverse events occurred, and infection accounted for 54.5% (12/22); no severe adverse reactions were observed during 20-week follow-up. Conclusion:Tocilizumab is safe and effective in treatment of sJIA, with decreasing inflammation, improving disease activity and reducing glucocorticosteroid use.
Key words: Arthritis, juvenile rheumatoid/drug therapy    Glucocorticoids/therapeutic use    Interleukin-6    Antibodies, monoclonal/therapeutic use    Treatment outcome    Safety
收稿日期: 2017-04-01 出版日期: 2017-08-25
CLC:  R725.9  
通讯作者: 卢美萍(1966-),女,博士,主任医师,博士生导师,主要从事儿童呼吸及风湿免疫过敏性疾病研究;E-mail:meipinglu@zju.edu.cn;http://orcid.org/0000-0002-3264-6397     E-mail: meipinglu@zju.edu.cn
作者简介: 邹丽霞(1979-),女,硕士,主治医师,主要从事儿童风湿免疫过敏性疾病研究;E-mail:xrjw@zju.edu.cn;http://orcid.org/0000-0002-8942-3864
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引用本文:

邹丽霞 等. 人源化白细胞介素-6受体抗体治疗全身型幼年特发性关节炎的疗效及安全性[J]. 浙江大学学报（医学版）, 2017, 46(4): 421-426.

ZOU Lixia, LU Meiping, GUO Li, TENG Liping, XU Yiping, ZHENG Qi. Efficacy and safety of humanized interleukin-6 receptor antibody in treatment of systemic juvenile idiopathic arthritis. Journal of ZheJiang University(Medical Science), 2017, 46(4): 421-426.

链接本文:

http://www.zjujournals.com/med/CN/10.3785/j.issn.1008-9292.2017.08.12    或    http://www.zjujournals.com/med/CN/Y2017/V46/I4/421

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