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世界核心医学期刊文摘（胃肠病学分册） 2005年第9期1卷 5-6页

作者： korzenik j.r. Dieckgraefe B.K. Valentine j.F. 刘丽娜 MGH Crohn's and Colitis Center Gastrointestinal Unit Massachusetts General Hospital Cambridge St. Boston MA 02114 United States Dr.

BACKGrOUND: Sargramostim, granulocyte-macrophage colony-stimulating factor, a hematopoietic growth factor, stimulates cells of the intestinal innate immune system. Preliminary studies suggest sargramostim may have activity in Crohn’s d isease. To evaluate this novel therapeutic approach, we conducted a randomized, placebocontrolled trial. METHODS: Using a 2∶1 ratio, we randomly assigned 124 patients with moderatetosevere active Crohns disease to receive 6 μg of sargramostim per kilogram per day or placebo subcutaneously for 56 days. Antibio tics and aminosalicylates were allowed; immunosuppressants and glucocorticoids w ere prohibited. The primary end point was a clinical response, defined by a decr ease from baseline of at least 70 points in the Crohns Disease Activity Index (CDAI) at the end of treatment (day 57). Other end points included changes in di sease severity and the healthrelated quality of life and adverse events. rESUL TS: There was no significant difference in the rate of the primary end point of a clinical response defined by a decrease of at least 70 points in the CDAI scor e on day 57 between the sargramostim and placebo groups (54 percent vs. 44 perce nt, P=0.28). However, significantly more patients in the sargramostim group than in the placebo group reached the secondary end points of a clinical response de fined by a decrease from baseline of at least 100 points in the CDAI score on da y 57 (48 percent vs. 26 percent, P=0.01) and of remission, defined by a CDAI sco re of 150 points or less on day 57 (40 percent vs. 19 percent, P=0.01). The rate s of either type o f clinical response and of remission were significantly higher in the sargramost im group than in the placebo group on day 29 of treatment and 30 days after trea tment. The sargramostim group also had significant improvements in the quality o f life. Mildtomoderate injectionsite reactions and bone pain were more com mon in the sargramostim group, and three patients in this gro

关键词：克罗恩病治疗活动安慰剂对照活动性指数次要终点临床效应造血生长因子新型治疗方法临床缓解生活质量变化

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