Steroid-sparing properties of sargramostim in patients with corticosteroid-dependent Crohn's disease: a randomised, double-blind, placebo-controlled, phase 2 study
Steroid-sparing properties of sargramostim in patients with corticosteroid-dependent Crohn's disease: a randomised, double-blind, placebo-controlled, phase 2 study
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DOI：
10.1136/gut.2008.165738
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发表时间：
2009-10-01
期刊：
影响因子：
24.5
通讯作者：
Humphries, T. J.
中科院分区：
文献类型：
--
作者：
Valentine, J. F.;Fedorak, R. N.;Humphries, T. J.
目的：虽然皮质类固醇治疗可以缓解克罗恩病，但长期使用皮质类固醇是不可取的。这项随机临床试验评估了天然免疫激活剂--重组人粒细胞-巨噬细胞集落刺激因子对皮质类固醇依赖型克罗恩病患者的疗效。设计：患者按2：1的比例随机给予沙格拉莫替钠6 mg/kg皮下注射，每日一次，或服用安慰剂，疗程长达22周。研究包括(1)辅助阶段(1-4周)，患者接受研究药物加皮质类固醇治疗；(2)强制皮质类固醇逐渐减少阶段(4-14周)；(3)观察阶段(4周)，患者接受研究药物加强的松治疗
Objective: Although treatment with corticosteroids induces remission in Crohn's disease, prolonged exposure to corticosteroids is undesirable. This randomised clinical trial evaluated the efficacy of recombinant human granulocyte-macrophage colony-stimulating factor (sargramostim), an activator of innate immunity, in corticosteroid-dependent patients with Crohn's disease.Design: Patients were randomised in a 2: 1 ratio, to sargramostim 6 mu g/kg subcutaneously once daily or placebo for up to 22 weeks. The study consisted of (1) an adjunctive phase (weeks 1-4) in which patients received study drug plus corticosteroid therapy; (2) a forced corticosteroid tapering phase (weeks 4-14); and (3) an observation phase (4 weeks) in which patients received study drug plus prednisone