Ricart E, Panaccione R, Loftus E V, Tremaine W J, Sandborn W J
Inflammatory Bowel Disease Clinic, Division of Gastroenterology and Hepatology, Mayo Clinic and Mayo Foundation, Rochester, Minnesota 55905, USA.
Am J Gastroenterol. 2001 Mar;96(3):722-9. doi: 10.1111/j.1572-0241.2001.03612.x.
The aim of this study was to report the clinical outcome and adverse events in the first 100 patients with refractory inflammatory and/or fistulizing Crohn's disease treated with infliximab at the Mayo Clinic.
Patient data was abstracted from medical records. Clinical response was classified as complete response, partial response, and nonresponse.
Indications for infliximab therapy were: inflammatory disease (61 patients), fistulizing disease (26 patients), or both (13 patients). Patients received one to seven infusions of infliximab (5 mg/kg) for a total of 242 infusions. In all, 50 patients had complete response, 22 had partial response, and 28 had nonresponse. Median time to response was 7 days (range 1-21 days). Median duration of response was 10.3 weeks (range 3-25 wk). A total of 95 patients received concomitant treatment with immune modifiers. Steroid withdrawal was possible in 29/40 patients (73%). Median time of follow-up was 34 wk (range 14-48 wk). Clinically significant adverse events after infliximab included: abscess formation in two patients (perianal, peristomal), pneumonia in two patients, varicella zoster in three patients, candida esophagitis in one patient, and infusion-related reactions in 19 patients. A total of 23 patients were continued on infliximab as maintenance treatment.
This study provides additional evidence that infliximab is safe and beneficial in clinical practice for refractory Crohn's disease.
本研究旨在报告梅奥诊所首批100例接受英夫利昔单抗治疗的难治性炎症性和/或瘘管性克罗恩病患者的临床结局及不良事件。
从病历中提取患者数据。临床反应分为完全缓解、部分缓解和无反应。
英夫利昔单抗治疗的适应证为：炎症性疾病（61例患者）、瘘管性疾病（26例患者）或两者兼具（13例患者）。患者接受了1至7次英夫利昔单抗（5 mg/kg）输注，共242次输注。总共有50例患者完全缓解，22例部分缓解，28例无反应。反应的中位时间为7天（范围1 - 21天）。反应的中位持续时间为10.3周（范围3 - 25周）。共有95例患者接受了免疫调节剂的联合治疗。40例患者中有29例（73%）可以停用类固醇。中位随访时间为34周（范围14 - 48周）。英夫利昔单抗治疗后具有临床意义的不良事件包括：2例患者出现脓肿形成（肛周、造口周围），2例患者出现肺炎，3例患者出现水痘带状疱疹，1例患者出现念珠菌食管炎，19例患者出现输注相关反应。共有23例患者继续接受英夫利昔单抗维持治疗。
本研究提供了更多证据，表明英夫利昔单抗在临床实践中治疗难治性克罗恩病是安全且有益的。
