治疗更新5月问题凸显了抗生素治疗克罗恩病的潜在作用[1]。Colombel博士表示需要适当的抗生素,是基于目前的病机理论,即他们对细胞外和细胞内的细菌是有效的。副结核分枝杆菌的可能作用,尽管有争议,也不应该被忽视。报告也强调,试验的抗生素应该足够长的时间来证明任何可能的利益。基于Gui的观察研究et al,[2]在1999年8月,我们开始一个适当的驱动的澳大利亚多中心,安慰剂对照,双盲试验的克拉霉素、利福克罗恩氏病和氯法齐明活跃。所有受试者接受强的松的圆锥形方案条目除了抗生素或匹配的安慰剂。如果达到缓解在16周,和强的松,科目继续试验药物2年了。然后有一个进一步的临床和结肠镜检查随访一年。研究的目的是确定是否这种抗生素治疗克罗恩病的患者的长期利益。主要的端点是复发率在1、2和3年。 The latter is particularly important to see if there is an effect on the natural history of the disorder. Secondary endpoints include remission at 4 months, safety and quality of life. As of May 2001, 171 of the 212 subjects required have been enrolled. Recruitment will continue until the end of July. To date, the likelihood of being in remission at 16 weeks and continuing in the study is 60%. Once past this point, 92% are ongoing. Only five patients have been withdrawn for probable reactions to the trial medication, four with elevated liver enzymes and one who developed a rash. An Independent Data Monitoring Committee, which recently conducted the first interim analysis, unanimously recommended that the trial continue. Because of the necessary length of therapy the results will not be known until 2004. The IDMC will continue to assess the progress. We believe this study will answer the important questions in the treatment of Crohn's disease raised by Dr Colombel.