Service d'Hépatogastroentérologie, Centre Hospitalier Universitaire de Bicêtre, Assistance Publique-Hôpitaux de Paris, Université Paris Sud, France.
Curr Drug Targets. 2011 Sep;12(10):1413-6. doi: 10.2174/138945011796818252.
Ulcerative colitis (UC) is a chronic inflammatory bowel disease that is thought to affect 1780000 patients in USA and Europe. Its incidence is increasing rapidly in Asia. Drugs with proven clinical activity that are currently used in UC patients include salicylates, steroids, azathioprine and infliximab. None of them is active in every patient and all carry significant side effects. There is a need for other active drugs in UC. Low dose methotrexate has been used for decades in psoriasis, rheumatoid arthritis and Crohn's disease. In these diseases, it is an active, well tolerated and cheap drug. In UC there have been several open series, most of which are retrospective. Overall, these studies have shown promising results, with response rates of 50 to 72 %. There have been two randomized clinical trials of methotrexate vs placebo in UC. Both were negative but methotrexate was prescribed orally at suboptimal doses. So far, there is no evidence for the efficacy of methotrexate in UC. Therefore, there is a need for clinical trials with methotrexate using adequate dosage and the parenteral route. Two multicenter randomized trials of methotrexate 25 mg/week parenterally vs placebo are either ongoing (METEOR, the European trial) or being built up (MERIT, the US trial). These trials should determine if methotrexate is a valuable therapeutic option in UC.
溃疡性结肠炎（UC）是一种慢性炎症性肠病，据估计，美国和欧洲有 178 万名患者受到影响。其发病率在亚洲迅速上升。目前在 UC 患者中使用的具有明确临床疗效的药物包括柳氮磺胺吡啶、皮质类固醇、硫唑嘌呤和英夫利昔单抗。这些药物并非对每个患者都有效，而且都有显著的副作用。UC 需要其他有效的药物。低剂量甲氨蝶呤已在银屑病、类风湿关节炎和克罗恩病中使用了几十年。在这些疾病中，它是一种有效、耐受性好且廉价的药物。在 UC 中，已经有几项开放系列研究，其中大多数是回顾性的。总的来说，这些研究显示出有希望的结果，反应率为 50%至 72%。有两项甲氨蝶呤与安慰剂治疗 UC 的随机临床试验。这两项试验均为阴性，但甲氨蝶呤的剂量低于最佳剂量。到目前为止，还没有证据表明甲氨蝶呤对 UC 有效。因此，需要使用适当的剂量和给药途径进行甲氨蝶呤的临床试验。两项每周 25 毫克甲氨蝶呤静脉注射与安慰剂对照的多中心随机试验正在进行中（METEOR，欧洲试验）或正在筹备中（MERIT，美国试验）。这些试验应该确定甲氨蝶呤是否是 UC 有价值的治疗选择。
