Oren R, Moshkowitz M, Odes S, Becker S, Keter D, Pomeranz I, Shirin H, Reisfeld I, Broide E, Lavy A, Fich A, Eliakim R, Patz J, Villa Y, Arber N, Gilat T
Department of Gastroenterology at Ichilov, Tel Aviv, Israel.
Am J Gastroenterol. 1997 Dec;92(12):2203-9.
At present only one large controlled study has indicated that parenteral methotrexate may be effective in chronic active Crohn's disease (CD).
To evaluate the effectiveness of oral methotrexate in chronic steroid-dependent CD.
Patients with active CD, who have received steroids and/or immunosuppressives for at least 4 months during the preceding 12 months and with a current Harvey-Bradshaw index of > or = 7 were studied.
Methotrexate (12.5 mg weekly) or 6-mercaptopurine (50 mg daily), or placebo were given during the 9 months of the trial in addition to steroids and 5-aminosalicylic acid as clinically indicated.
Eighty-four patients were included (methotrexate, 26 patients; 6-mercaptopurine, 32 patients; placebo, 26 patients). The proportion of patients entering first remission as well as the proportions of patients relapsing after first remission were not significantly different between the groups. The mean Harvey-Bradshaw index and the mean monthly steroid dose were also similar. However, when each patient was evaluated as his or her own control, the reduction in steroid dose, the general well being, and the reduction in abdominal pain were significantly better in the methotrexate treated patients.
Methotrexate at a weekly oral dose of 12.5 mg was found to be moderately better than 6-mercaptopurine and placebo in patients with chronic active CD.
目前仅有一项大型对照研究表明肠外甲氨蝶呤可能对慢性活动性克罗恩病（CD）有效。
评估口服甲氨蝶呤对慢性依赖类固醇的CD的有效性。
研究对象为活动性CD患者，这些患者在过去12个月中接受类固醇和/或免疫抑制剂治疗至少4个月，且当前哈维-布拉德肖指数≥7。
在为期9个月的试验期间，除根据临床指征给予类固醇和5-氨基水杨酸外，还给予甲氨蝶呤（每周12.5毫克）或6-巯基嘌呤（每日50毫克）或安慰剂。
共纳入84例患者（甲氨蝶呤组26例；6-巯基嘌呤组32例；安慰剂组26例）。各组进入首次缓解期的患者比例以及首次缓解后复发的患者比例无显著差异。平均哈维-布拉德肖指数和平均每月类固醇剂量也相似。然而，当将每位患者作为自身对照进行评估时，甲氨蝶呤治疗的患者在类固醇剂量减少、总体健康状况以及腹痛减轻方面明显更好。
对于慢性活动性CD患者，发现每周口服12.5毫克甲氨蝶呤比6-巯基嘌呤和安慰剂稍好。
