英夫利西单抗治疗炎性关节炎不良事件分析

A study:adverse drug reactions to infliximab treatment in patients with inflammatory arthritis

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。

AIM To evaluate the tolerance and risk of imqiximab in the treatment of patients with inflammatory arthritis including rheumatoid arthritis （RA）, ankylosing spondylitis （AS）, psoriatic arthritis （PsA）. METHODS According to the World Health Organization Adverse Reaction Terminology （WHOART） classification, a retrospective analysis from January 2007 to December 2010 about incident rate of adverse events （AEs）, serious adverse events （SAE） and abnormal laboratory test results was conducted in 137 patients with RA, AS and PsA treated with infliximab, to estimate the safety. RESULTS Among the 137 patients treated with infliximab, 14 patients were screened AEs associated to the medication, including allergic reactions （4.4%）, upper respiratory infection （2.9%）, tuberculosis （1.5%） and so on. Except 3 patients of SAE occurred （2.2%, 1 patient of severe infusion reactions and 2 patients of tuberculosis） and had to withdraw from infliximab, the others completed the treatment after the symptomatic treatment. CONCLUSION The tumor necrosis factor antagonists infliximab is safe and well tolerated in patients with inflammatory arthritis. The serious infusion reaction and tuberculosis are the main reasons of withdrawal, thereby, the indication should be strictly abide by avoiding SAE such as tuberculosis.