Arora S, Katkov W, Cooley J, Kemp J A, Johnston D E, Schapiro R H, Podolsky D
Division of Gastroenterology, New England Medical Center, Boston, Massachusetts, USA.
Hepatogastroenterology. 1999 May-Jun;46(27):1724-9.
BACKGROUND/AIMS: Immunosuppression with methotrexate may be useful in the treatment of Crohn's disease. We tested the efficacy of methotrexate in refractory Crohn's disease in a randomized, controlled trial.
Randomized, double-blind placebo-controlled trial of methotrexate in 33 patients with steroid-dependent Crohn's disease, 33% of whom had previously failed therapy with 6-mercaptopurine. Patients were given placebo or oral methotrexate 15 mg/week, or adjusted up to 22.5 mg/week, for up to 1 year or until treatment failure. Outcome was assessed by reduction in prednisone dosage, Crohn's Disease Activity Index, hospital admission, and laboratory parameters.
Four patients were dropped from the study for non-compliance and one because of intercurrent illness, and 28 patients could be evaluated. Fewer methotrexate-treated patients (6/13 or 46%) had flares of Crohn's disease as compared to placebo-treated patients (12/15 or 80%), but this did not achieve statistical significance (p<0.1). There was a non-significant trend toward an increased number of significant side effects in the methotrexate-treated patients (3/13 or 23%) as compared to the placebo-treated patients (0/15 or 0%) (p<0.2). Laboratory indices of inflammation did not differ between the two groups.
The methotrexate-treated group showed a trend toward fewer Crohn's disease flares, balanced by an increased number of significant side effects.
背景/目的：甲氨蝶呤免疫抑制疗法可能对克罗恩病的治疗有效。我们在一项随机对照试验中测试了甲氨蝶呤对难治性克罗恩病的疗效。
对33例依赖类固醇的克罗恩病患者进行甲氨蝶呤随机双盲安慰剂对照试验，其中33%的患者先前使用6-巯基嘌呤治疗失败。患者接受安慰剂或口服甲氨蝶呤15毫克/周，或根据情况调整至22.5毫克/周，持续1年或直至治疗失败。通过泼尼松剂量减少、克罗恩病活动指数、住院情况和实验室参数来评估结果。
4例患者因不依从退出研究，1例因并发疾病退出，28例患者可进行评估。与接受安慰剂治疗的患者（12/15或80%）相比，接受甲氨蝶呤治疗的患者中克罗恩病复发的较少（6/13或46%），但未达到统计学显著性（p<0.1）。与接受安慰剂治疗的患者（0/15或0%）相比，接受甲氨蝶呤治疗的患者出现明显副作用的数量有增加的趋势，但无统计学意义（3/13或23%）（p<0.2）。两组间炎症的实验室指标无差异。
甲氨蝶呤治疗组克罗恩病复发次数有减少趋势，但明显副作用数量增加，二者相抵。
