肿瘤坏死因子拮抗剂治疗风湿性疾病安全性的短期临床观察

A short-term safety study of tumor necrosis factor antagonists in rheumatic diseases

目的描述肿瘤坏死因子（TNF）-α拮抗剂治疗风湿性疾病发生的不良反应，评价临床应用的安全性和耐受性。方法对2007年1月至2008年10月使用TNF-α拈抗剂的患者从临床症状、体征及实验室检查方面记录使用过程中发生的不良反应及程度和最终结局。结果78例患者中35％（27／78）为类风湿关节炎（RA），41％（32／78）为强直性脊柱炎（AS），17％（13／78）为银屑病关节炎（PsA），6％（5／78）为未分化脊柱关节病（uSpA）。59例患者使用依那西普，7例（12％）发生注射局部反应、上呼吸道感染及结核病等不良反应。19例患者使用英夫利西单抗，3例（16％）发生不良反应，1例（AS）为上呼吸道感染，1例（AS）前两次均在输注完24h内出现全身红色丘疹及心悸，1例（RA）输注4次后出现不明原因发热。部分不良反应可自行消失，其余经适当处理后痊愈。结论证实依那西普和英夫利西单抗治疗风湿性疾病具有较好的安全性和耐受性，发生的不良反应是温和的，经适当处理可痊愈。

Objective To evaluate the safety and tolerance of tumor necrosis faetor-α （TNF-α） antagonists in the treatment of rheumatic diseases. Methods The ineidence of adverse events and their ultimate outcomes based on the clinical symptoms, signs and laboratory parameters of patients treated with etanereept or infliximab during January 2007 to October 2008 were analyzed. Results Severty eight patients were included. Most were rheumatoid arthritis （35%） and ankylosing spondylitis （41%） patients. Few of them were psoriasis arthritis （17%） patients and undifferentiated spondyloarthropathy （6%） patients. Among those patients, 59 patients were treated with etanercept, 7 patients （12%） had adverse events in which the majority were injection reactions, upper respiratory tract infeetion and tuberculosis. Nineteen patients were treated with infliximah, in whieh 3 patients （16%） had adverse events. One patient （AS） had upper respiratory traet infection. One ease （AS） had red papules all over the body and palpitations in the first 24 hours after two infusions. One patient （RA） had fever without identifiable causes after the 4th infusion. Some of the adverse reactions might subside without intervention, while others were eontrolled after proper treatment. Conclusion Both etanereept and infliximab have good safety and tolerance in treating rheumatic diseases, the adverse reactions are generally mild and ean be eontrolled by appropriate treatment.