Fitzcharles Mary-Ann, Clayton Denise, Ménard Henri André
Division of Rheumatology, McGill University, Montreal, Quebec, Canada.
J Rheumatol. 2002 Dec;29(12):2525-30.
To audit a first clinical experience of treating rheumatic disease patients with infliximab in the setting of an academic tertiary care rheumatology practice.
The infusion history of patients referred to the McGill University Health Centre during the first 18 month period of a special access program for treatment with infliximab, a tumor necrosis factor-a antibody, was audited for disease characteristics, dosing schedule for infliximab, concomitant treatments, response rate, and side effect profile.
Forty-one patients received a total of 300 infusions of infliximab over a period of 9 +/- 5 months (mean +/- standard deviation). Rheumatic disease indications were rheumatoid arthritis in 30, spondyloarthropathy in 6, psoriatic arthritis in 2, juvenile onset polyarthritis in 2, and scleroderma in one. Disease duration was 17 +/- 11 years. Concomitant treatment with steroids and methotrexate was present in 68% and 54%, respectively. Infliximab treatment was continued beyond 5 infusions or 22 weeks in 63%. Of the 26 patients continuing treatment, adjustment to dosing and/or interval schedule of infusions was made in 58%. The clinical response rate was moderately to greatly improved in 96%. Severe side effects considered directly related to the treatment were observed in 6 (15%) patients; less severe side effects, which did not preclude continuation of treatment but frequently required medical intervention, were noted in 93%.
Infliximab is a valuable treatment for patients with resistant rheumatic diseases in the short term. Both the serious, and the frequent, more benign complication rate observed in this group of patients should alert physicians to be vigilant in the routine care of patients treated with infliximab.
审核在学术性三级医疗风湿病诊疗机构中使用英夫利昔单抗治疗风湿病患者的首次临床经验。
对在英夫利昔单抗（一种肿瘤坏死因子-α抗体）特殊获取计划的前18个月期间转诊至麦吉尔大学健康中心的患者的输注记录进行审核，内容包括疾病特征、英夫利昔单抗给药方案、联合治疗、缓解率和副作用情况。
41例患者在9±5个月（平均±标准差）内共接受了300次英夫利昔单抗输注。风湿病适应证包括类风湿关节炎30例、脊柱关节病6例、银屑病关节炎2例、幼年型多关节炎2例和硬皮病1例。病程为17±11年。分别有68%和54%的患者同时接受类固醇和甲氨蝶呤治疗。63%的患者英夫利昔单抗治疗持续超过5次输注或22周。在继续治疗的26例患者中，58%的患者调整了输注剂量和/或间隔时间。96%的患者临床缓解率有中度至显著改善。6例（15%）患者出现被认为与治疗直接相关的严重副作用；93%的患者出现不太严重的副作用，这些副作用虽不排除继续治疗，但常需医疗干预。
英夫利昔单抗在短期内是治疗难治性风湿病患者的一种有价值的疗法。在这组患者中观察到的严重和频繁出现的较为良性的并发症发生率应提醒医生在英夫利昔单抗治疗患者的常规护理中保持警惕。
