Arnott I D, McDonald D, Williams A, Ghosh S
Gastrointestinal Unit, Western General Hospital, University of Edinburgh, Edinburgh EH4 2XU, UK.
Aliment Pharmacol Ther. 2001 Oct;15(10):1639-46. doi: 10.1046/j.1365-2036.2001.01092.x.
Infliximab is an established treatment for steroid-resistant and fistulating Crohn's disease. Although efficacy has been shown in clinical trials, financial implications often limit its use and limited data exist regarding clinical practice.
To audit the clinical effectiveness of Infliximab.
We prospectively audited 50 consecutive patients [28 females; median age, 34 years (17-70 years)]. Disease activity and response rates were assessed by the Harvey-Bradshaw index. Clinical and disease data were collected and blood was taken for inflammatory markers, complement and double-stranded DNA antibodies. Patients received Infliximab at 5 mg/kg and were followed for 12 weeks.
Indications for Infliximab were refractory Crohn's disease in 39 patients, fistulating Crohn's disease in six, pyoderma gangrenosum in one, pouchitis in two and coeliac disease in two. Thirty-one (79%) of the refractory Crohn's disease patients and four (66%) of the fistulating patients responded at 4 weeks. Twenty-one (54%) of the refractory Crohn's disease patients had a continued response at 12 weeks. Perianal disease was more prevalent in non-responders (7/8 vs. 12/31, P < 0.02).
Response rates to Infliximab in our group are comparable to those of clinical trials. Despite the expense, it remains a useful adjunct to treatment in this otherwise difficult group of patients. Patients with perianal disease responded less well in our cohort.
英夫利昔单抗是治疗对类固醇耐药的瘘管性克罗恩病的既定疗法。尽管临床试验已显示其疗效，但经济因素常常限制其使用，且关于临床实践的数据有限。
审核英夫利昔单抗的临床疗效。
我们前瞻性地审核了连续50例患者[28例女性；中位年龄34岁（17 - 70岁）]。通过哈维 - 布拉德肖指数评估疾病活动度和缓解率。收集临床和疾病数据，并采集血液检测炎症标志物、补体和双链DNA抗体。患者接受5mg/kg的英夫利昔单抗治疗，并随访12周。
英夫利昔单抗的适应证为39例难治性克罗恩病、6例瘘管性克罗恩病、1例坏疽性脓皮病、2例袋炎和2例乳糜泻。31例（79%）难治性克罗恩病患者和4例（66%）瘘管性患者在4周时出现缓解。21例（54%）难治性克罗恩病患者在12周时持续缓解。肛周疾病在未缓解患者中更常见（7/8 vs. 12/31，P < 0.02）。
我们组中英夫利昔单抗的缓解率与临床试验相当。尽管费用高昂，但在这群治疗困难的患者中，它仍是一种有用的辅助治疗方法。在我们的队列中，肛周疾病患者的缓解情况较差。
