Department of Gastroenterology, The Adelaide and Meath Incorporating the National Childrens Hospital and Trinity College Dublin, Tallaght, Dublin 24, Ireland.
Eur J Gastroenterol Hepatol. 2011 Jul;23(7):603-6. doi: 10.1097/MEG.0b013e3283479125.
Assessment of the long-term safety of anti-tumour necrosis factor therapies is vital for the safe treatment of inflammatory bowel disease, a disease affecting a young cohort of patients.
The aim of this retrospective study was to assess the safety and long-term outcome of infliximab use in clinical practice in our institution on an intention to treat basis over the 10-year period from December 1998 to 31 December 2008.
All cases receiving infliximab for ulcerative colitis or Crohn's disease over a 10-year period were identified from hospital pharmacy records. The study was based on a single centre cohort, with an unselected patient group.
A total of 271 patients were identified as receiving infliximab for either Crohn's disease or ulcerative colitis over the 10-year study period. In total, 2169 infusions were given to the patient cohort. Fifty adverse events led to discontinuation of infliximab therapy in 47 cases. Two patients stopped due to neurological complications. There were six malignancies diagnosed within the cohort during the study period. Four of these were diagnosed while the individual was receiving Infliximab and two occurred at an interval of 21-52 months post their final infliximab infusion. A total of five deaths (1.5%) were observed during the study period.
Infliximab therapy seems to be safe and efficacious in the long term. Although the development of malignancy remains a concern, we have not seen an increased risk of serious infection within our cohort.
本回顾性研究旨在评估本机构自 1998 年 12 月至 2008 年 12 月 31 日的 10 年期间，以意向治疗为基础，使用英夫利昔单抗治疗炎症性肠病的安全性和长期结果。
从医院药房记录中确定了 10 年内接受英夫利昔单抗治疗溃疡性结肠炎或克罗恩病的所有病例。该研究基于一个单中心队列，为非选择性患者群体。
在 10 年的研究期间，共有 271 名患者被确定为接受英夫利昔单抗治疗克罗恩病或溃疡性结肠炎。总共给患者队列给予了 2169 次输注。50 例不良事件导致 47 例患者停止英夫利昔单抗治疗。2 例患者因神经系统并发症而停止。在研究期间，该队列中诊断出 6 例恶性肿瘤。其中 4 例在接受英夫利昔单抗治疗期间被诊断出，2 例发生在最后一次英夫利昔单抗输注后 21-52 个月。在研究期间共观察到 5 例死亡（1.5%）。
英夫利昔单抗治疗似乎是安全有效的。尽管恶性肿瘤的发展仍然令人担忧，但我们在队列中没有看到严重感染风险增加。
