Low-Dose Cyclosporine for the Treatment of Crohn's Disease

作者：Brian G. Feagan, John WD McDonald, James Rochon, Andreas Laupacis, Richard Neil Fedorak, Douglas G. Kinnear, Fred G. Saibil, Aubrey Groll, André Archambault, Richard Gillies, Barbara Valberg, Elizabeth Jan Irvine · 发表于：New England Journal of Medicine · 年份：1994 · DOI：10.1056/nejm199406303302602 · 被引用次数：258 · 研究领域：Inflammatory Bowel Disease、Microscopic Colitis、Immunodeficiency and Autoimmune Disorders

BACKGROUND: Long-term corticosteroid therapy for Crohn's disease is associated with important types of morbidity, such as osteoporosis. Safe and effective alternative treatments are required. Although a short-term benefit of cyclosporine in active Crohn's disease has been suggested, the long-term safety and efficacy of this treatment have not been established. METHODS: We conducted a randomized, double-blind, placebo-controlled evaluation of the effect of 18 months of low-dose cyclosporine treatment on the course of Crohn's disease. Adult patients whose disease had been active within the previous two years were randomly assigned to receive cyclosporine (151 patients) or placebo (154 patients) in addition to their usual therapy. Randomization was stratified according to center and score on the Crohn's Disease Activity Index (193 patients had scores of 150 or less, and 112 had scores greater than 150). The primary outcome measure was clinically important worsening of Crohn's disease, defined as a 100-point increase in the Crohn's Disease Activity Index from the patient's base-line value. Secondary outcomes were the use of prednisone and 5-amino-salicylates, mean score on the Crohn's Disease Activity Index and mean quality-of-life score, and the need for surgery. RESULTS: The condition of more patients worsened with cyclosporine than with placebo (91 of 151, or 60.3 percent, vs. 80 of 154, or 51.9 percent; P = 0.10). The median time to worsening of disease in patients receiving ...