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目的探讨英夫利西单抗治疗炎性关节炎前后不良事件,评价其临床使用的安全性。方法随访2007年1月至2010年12月期间进行英夫利西单抗治疗的137例(共537次注射)类风湿关节炎、强直性脊柱炎和银屑病关节炎患者,对其治疗期间及随访过程中所发生的全部不良事件、严重不良事件、实验室检查进行总结分析,根据世界卫生组织不良反应术语命名系统进行分类、观察不良事件的发生情况。结果有14例18例次发生治疗药物相关的不良事件,主要表现为轻度过敏反应、上呼吸道感染症状、结核感染等,发生率分别为4.4%、2.9%、1.5%等。除3例(2.2%)发生重度不良事件患者(1例患者发生严重的输液反应和2例结核感染者)需停药外,其余患者经对症处理后症状完全消失,可继续维持治疗用药。结论英夫利西单抗治疗炎性关节炎具有良好的安全性,严重的输液反应和结核感染是无法继续接受治疗的主要原因,建议严格掌握适应证,避免增加结核等严重不良事件的发生。
Objective To investigate the safety of infliximab in the treatment of inflammatory arthritis before and after adverse events, to evaluate the safety of its clinical use. METHODS: A total of 137 patients (537 injections) of rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis were treated with infliximab during the period from January 2007 to December 2010 and their duration of treatment and follow-up All adverse events, serious adverse events, and laboratory tests during the course of the treatment were summarized and analyzed. Classification was made according to the World Health Organization terminology system for adverse reactions, and the incidence of adverse events was observed. Results Of the 14 cases, 18 cases were followed up for the treatment of drug-related adverse events. The main adverse reactions were mild allergic reaction, upper respiratory tract infection and tuberculosis. The incidence rates were 4.4%, 2.9% and 1.5% respectively. Except 3 patients (2.2%) who had severe adverse events (1 patient had severe infusion reaction and 2 tuberculosis infection) needed to be discontinued, the other patients disappeared completely after symptomatic treatment and could continue to maintain the medication. Conclusion Infliximab treatment of inflammatory arthritis has good safety. Severe transfusion reactions and tuberculosis infection are the main reasons that treatment can not be continued. It is suggested that indications should be strictly controlled to avoid increasing incidence of serious adverse events such as tuberculosis.