Schaible T F
Immunology Medical Affairs, Centocor Inc, Malvern, Pennsylvania 19355, USA.
Can J Gastroenterol. 2000 Sep;14 Suppl C:29C-32C. doi: 10.1155/2000/698523.
Infliximab is a chimeric anti-tumour necrosis factor-alpha monoclonal antibody that has been studied for the treatment of Crohn's disease and rheumatoid arthritis. In several placebo controlled, randomized clinical trials and open trials, 771 patients have been given infliximab (a further 192 received placebo). Follow-up for safety has included the time of study (12 weeks after the last infusion), plus three additional years. Acute infusion reactions (headache, fever, chills, urticaria, chest pain) were seen in 17% of patients receiving infliximab compared with 7% of those receiving placebo. While infections were reported more frequently overall in the patients given infliximab (26% over 27 weeks of follow-up versus 16% of placebo-treated patients over 20 weeks of follow-up), there was no increased risk of serious infections. There was no difference in the overall mortality rate between the groups. While low titres of autoantibodies developed in less than 10% of patients, drug-induced lupus was seen in less than 1%, with these cases resolving upon discontinuation of the drug. Overall, infliximab showed an acceptable safety profile.
英夫利昔单抗是一种嵌合型抗肿瘤坏死因子-α单克隆抗体，已被用于研究治疗克罗恩病和类风湿性关节炎。在多项安慰剂对照、随机临床试验及开放试验中，771例患者接受了英夫利昔单抗治疗（另有192例接受安慰剂治疗）。安全性随访时间包括研究期间（最后一次输注后12周）及另外3年。接受英夫利昔单抗治疗的患者中，17%出现急性输注反应（头痛、发热、寒战、荨麻疹、胸痛），而接受安慰剂治疗的患者中这一比例为7%。虽然接受英夫利昔单抗治疗的患者总体上感染报告更为频繁（随访27周期间为26%，而接受安慰剂治疗的患者随访20周期间为16%），但严重感染风险并未增加。两组的总体死亡率无差异。虽然不到10%的患者产生了低滴度自身抗体，但药物性狼疮的发生率不到1%，这些病例在停药后病情缓解。总体而言，英夫利昔单抗显示出可接受的安全性。
