重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白联合改善病情抗风湿药治疗中国人群风湿性疾病的安全性研究

An open-label trial on the safety of recombinant human tumor necrosis factor-Fc treatment in Chinese rheumatic diseases patients

目的评价注射用重组人Ⅱ型肿瘤坏死因子仪受体一抗体融合蛋白（rhTNFR：Fc）治疗大样本量风湿性疾病患者的安全性。方法观察从2006年5月至2009年3月间使用rhTNFR：Fc治疗的类风湿关节炎（RA）、强直性脊柱炎（As）、幼年特发性关节炎（JIA）和银屑病关节炎（PsA）患者治疗期间内所发生的不良事件。结果共对2041病例患者进行观察，其中RA1388例，AS421例，其他232例。其中RA中不良事件发生率为13．47％，最常见的为注射部位反应（2．67％）、皮疹（1．87％）和转氨酶升高（1．80％）。AS总的不良事件发生率为10．45％，常见的是注射部位反应（5．23％）、转氨酶升高（2．38％）和皮疹（0．71％）。全部感染的发生率为2．40％，最常见的感染为上呼吸道感染。本次研究中未观察到严重不良事件、死亡、结核病和恶性肿瘤的发生。结论rhTNFR：Fc治疗RA、AS等风湿性疾病具有良好的安全性。

Objective To compare the safety of recombinant human tumor necrosis factor-Fc （rhTNFR： Fc） and other DMARDs, in patients with rhe, matoid arthritis （RA）, ankylosing spondylitis （AS）, juvenile idiopathetic arthritis （JIA） or psoriatic arthritis （PsA）. Methods Patients who received rhTNFR：Fc 25 mg twice weekly from May 2006 to March 2009 were involved in this open-lable study. Safety assessments were carried out at regular intervals. Results Of the 2014 patients enrolled in the open-label trial, 1388, 421 and 232 were RA, AS or other diseases, such as JIA and PsA respectively： Frequent adverse events included injection-site reactions （2.67%）, rash （1.87%） and hyperamino transferase （1.80%） in RA patients. Similarly, injection-site reactions （5.23%）, hyperaminotransferase （2.38%） and rash （0.71%） were frequent in AS patients. Upper respiratory infection was most frequent among infectious adverse events. There were no reports of patients with serious adverse events, dead case, TB infection and malignancies： Conclusion rhTNFR：Fc has shown a favourable safety profile in Chinese rheumatic disease patients.