Randomised Controlled Trial of 6-Mercaptopurine versus placebo to prevent recurrence of Crohn's disease following surgic

6-巯基嘌呤与安慰剂预防手术后克罗恩病复发的随机对照试验

• 批准号: G0600329/1
• 负责人: Jack Satsangi
• 金额: $ 188.51万
• 依托单位: University of Edinburgh
• 依托单位国家: 英国
• 项目类别: Research Grant
• 财政年份: 2007
• 资助国家: 英国
• 起止时间: 2007 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=G0600329%2F1
• 关键词: Randomised; Controlled; Trial; Mercaptopurine; versus

Crohn s disease is a chronic disabling condition affecting the bowel. Although medical treatment is effective approximately 50% of patient will need an operation to remove an affected segment of bowel over the first 5 years after diagnosis. Recurrence following surgery occurs in the majority of patients. 6-Mercaptopurine is an effective treatment for the reduction of symptoms and maintenance of well being in Crohn s disease but its use to prevent post operative recurrence is poorly defined. Previous studies have been small, retrospective or flawed in design. In this multicentre study we wish to assess the value of the drug 6-mercaptopurine to prevent recurrence of Crohn s disease following surgery. We will use the recurrence of symptoms as the primary outcome measure, with endoscopic examination of the relevant area and the need for further sugery as secondary outcome measures. If this trial were to show an effect of the drug we would anticipate a wide uptake and improved quality of life for patients with Crohn s disease following surgery.

克罗恩病是一种影响肠道的慢性致残疾病。虽然药物治疗是有效的，但在诊断后的前5年内，大约50%的患者需要手术切除受影响的肠道部分。手术后复发在大多数患者中发生。6-巯基嘌呤是一种减轻克罗恩病症状和维持健康的有效治疗方法，但其用于预防手术后复发的用途尚不明确。以前的研究都是小规模的、回顾性的或设计上有缺陷的。在这项多中心研究中，我们希望评估药物6-巯基嘌呤在预防手术后克罗恩病复发中的价值。我们将使用症状复发作为主要的结果测量，相关区域的内窥镜检查和进一步手术的需要作为次要的结果测量。如果这项试验显示出药物的效果，我们预计克罗恩病患者手术后的广泛吸收和生活质量将得到改善。