Fellermann K, Steffen M, Stein J, Raedler A, Hämling J, Ludwig D, Loeschke K, Stange E F
Department of Internal Medicine I, Division of Gastroenterology, University of Lübeck, Lübeck, Germany.
Aliment Pharmacol Ther. 2000 Feb;14(2):171-6. doi: 10.1046/j.1365-2036.2000.00695.x.
Mycophenolate mofetil (MMF) is a new immunosuppressant with pharmacodynamic properties comparable to azathioprine. Recent reports found MMF to be effective in inflammatory bowel disease (IBD).
An open-label prospective and uncontrolled multicentre 6 month trial of MMF in combination with steroids was conducted in 24 chronic active IBD patients. A daily steroid demand of >/= 10 mg prednisone in the preceding 2 months and a Crohn's disease activity index (CDAI) > 150, or moderate to severe activity according to Truelove, served as criteria for chronic activity. The treatment consisted of a steroid pulse and tapering protocol in combination with MMF 2 g/day. A prednisone dose of 5 mg/day was maintained during months 4-6. The primary end-point was induction and maintenance of remission.
Only 10 of 24 patients had achieved remission after 3 months. All but one Crohn's disease patient had relapsed by the end of the study at 6 months. Depression and migraine necessitated drug withdrawal in two patients.
In conclusion, MMF 2 g/day was unable to induce and maintain remission for a period of 6 months in 23 of 24 chronic active IBD patients. Further controlled investigations are required in view of recent conflicting reports.
霉酚酸酯（MMF）是一种新型免疫抑制剂，其药效特性与硫唑嘌呤相当。最近的报告发现MMF对炎症性肠病（IBD）有效。
对24例慢性活动性IBD患者进行了一项为期6个月的开放标签前瞻性非对照多中心试验，将MMF与类固醇联合使用。前两个月每日泼尼松需求量≥10mg，克罗恩病活动指数（CDAI）>150，或根据Truelove标准为中度至重度活动，作为慢性活动的标准。治疗包括类固醇冲击和减量方案，联合MMF 2g/天。在第4至6个月期间维持泼尼松剂量为5mg/天。主要终点是诱导和维持缓解。
24例患者中只有10例在3个月后达到缓解。除1例克罗恩病患者外，所有患者在6个月研究结束时均复发。两名患者因抑郁和偏头痛而停药。
总之，24例慢性活动性IBD患者中有23例患者使用每日2g的MMF无法诱导并维持6个月的缓解。鉴于最近相互矛盾的报告，需要进一步进行对照研究。
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