Safety and efficacy of recombinant human interleukin 10 in chronic active Crohn's disease
Safety and efficacy of recombinant human interleukin 10 in chronic active Crohn's disease
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DOI：
10.1053/gast.2000.20196
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发表时间：
2000-12-01
期刊：
影响因子：
29.4
通讯作者：
Hanauer, SB
中科院分区：
文献类型：
--
作者：
Schreiber, S;Fedorak, RN;Hanauer, SB
背景与目的：白介素10(IL-10)是一种具有强大抗炎活性的细胞因子。我们观察了不同剂量重组人IL-10治疗克罗恩病(CD)的安全性和有效性。方法：采用前瞻性、多中心、双盲、安慰剂对照研究方法，对329例难治性CD患者进行前瞻性、多中心、双盲、安慰剂对照研究，以克罗恩病活动指数(CDAI)降低100分或MOVE为临床改善指标，以CDAI降低CDAI为临床缓解指标。
Background & Aims: Interleukin (IL)-10 is a cytokine with potent anti-inflammatory properties. We investigated the safety and efficacy of different doses of human recombinant (rhu)IL-10 in patients with Crohn's disease (CD), Methods: A prospective, multicenter, double-blind, placebo-controlled study was conducted in 329 therapy-refractory patients with CD, Clinical improvement was defined by a reduction of the Crohn's Disease Activity Index (CDAI) by 100 points or move and clinical remission by a decrease of the CDAI to