Cheifetz Adam, Smedley Michelle, Martin Sara, Reiter Monica, Leone Grace, Mayer Lloyd, Plevy Scott
Division of Clinical Immunology, Department of Medicine, The Mount Sinai School of Medicine, New York, New York, USA.
Am J Gastroenterol. 2003 Jun;98(6):1315-24. doi: 10.1111/j.1572-0241.2003.07457.x.
To assess the incidence and management of infusion reactions to infliximab, a chimeric monoclonal antibody that targets human tumor necrosis factor-alpha, in patients with Crohn's disease treated at a large infusion center.
A total of 165 consecutive patients who received 479 infliximab infusions in the Division of Clinical Immunology Infusion Center at Mount Sinai Medical Center from July, 1998 to January, 2001 were evaluated. Specific treatment protocols for initial and subsequent acute infusion reactions were followed and the outcomes documented.
The overall incidence of infusion reactions to infliximab was 6.1% (29 of 479) of infusions, affecting 9.7% (16 of 165) of patients. Mild, moderate, or severe acute reactions occurred in 3.1% (15 of 479), 1.2% (six of 479), and 1.0% (five of 479) of infliximab infusions, respectively. Use of treatment protocols resulted in rapid resolution of all acute reactions to infliximab. With the prophylaxis protocol, all patients who experienced an initial mild or moderate acute reaction were able to receive additional infusions. Four patients experienced a total of five severe acute reactions. Three patients were retreated: two patients had no further problems, whereas one patient had a second severe acute reaction that rapidly resolved with treatment. Suggesting that acute infusion reactions are not type I hypersensitivity reactions, in 11 patients who experienced 14 acute infusion reactions, serum tryptase levels were normal. Delayed infusion reactions occurred in 0.6% (three of 479) of infusions.
Infliximab infusions were accompanied by acute reactions in approximately 5% of infusions. These reactions did not seem to be true IgE-mediated type I hypersensitivity events. Using appropriate treatment protocols, these reactions were effectively treated and prevented upon retreatment in nearly all patients. Delayed reactions were rare, occurring in <1% of infusions.
评估在一家大型输液中心接受治疗的克罗恩病患者中，英夫利昔单抗（一种靶向人肿瘤坏死因子-α的嵌合单克隆抗体）输液反应的发生率及处理情况。
对1998年7月至2001年1月在西奈山医疗中心临床免疫输液中心接受479次英夫利昔单抗输液的165例连续患者进行评估。遵循针对初始及后续急性输液反应的特定治疗方案，并记录结果。
英夫利昔单抗输液反应的总体发生率为输液次数的6.1%（479次中的29次），影响了9.7%（165例中的16例）的患者。轻度、中度或重度急性反应分别发生在3.1%（479次中的15次）、1.2%（479次中的6次）和1.0%（479次中的5次）的英夫利昔单抗输液中。采用治疗方案使所有英夫利昔单抗急性反应迅速得到缓解。通过预防方案，所有经历过初始轻度或中度急性反应的患者都能够接受额外的输液。4例患者共经历了5次重度急性反应。3例患者接受了再次治疗：2例患者没有进一步问题，而1例患者出现了第二次重度急性反应，经治疗后迅速缓解。在经历14次急性输液反应的11例患者中，血清类胰蛋白酶水平正常，提示急性输液反应并非I型超敏反应。迟发性输液反应发生在0.6%（479次中的3次）的输液中。
英夫利昔单抗输液约5%会伴有急性反应。这些反应似乎并非真正由IgE介导的I型超敏反应事件。采用适当的治疗方案，这些反应在几乎所有患者再次治疗时都能得到有效治疗和预防。迟发性反应很少见，发生率低于输液次数的1%。
