Infliximab maintenance therapy for fistulizing Crohn's disease
Infliximab maintenance therapy for fistulizing Crohn's disease
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DOI：
10.1056/nejmoa030815
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发表时间：
2004-02-26
影响因子：
158.5
通讯作者：
van Deventer, SJ
中科院分区：
文献类型：
--
作者：
Sands, BE;Anderson, FH;van Deventer, SJ
背景：英夫利西单抗是一种抗肿瘤坏死因子的单克隆抗体，是无瘘管克罗恩病患者的有效维持治疗。目前尚不清楚英夫利西单抗是否是一种有效的维持治疗患者fistulas.METHODS：我们进行了一项多中心，双盲，随机，安慰剂对照试验，以评估英夫利西单抗维持治疗的疗效在306例成人患者克罗恩病和一个或多个引流腹部或肛周瘘至少三个月的持续时间。患者在第0、2和6周接受每公斤体重5 mg英夫利西单抗静脉给药。共有195名在第10周和第14周有反应的患者和87名无反应的患者被随机分配接受安慰剂或每8周5 mg英夫利西单抗治疗，并随访至第54周。主要分析是在第14周有应答并接受随机分组的患者中至应答丧失的时间。结果：接受英夫利西单抗维持治疗的患者至应答丧失的时间显著长于接受安慰剂维持治疗的患者（超过40周vs. 14周，P
BACKGROUND:Infliximab, a monoclonal antibody against tumor necrosis factor, is an effective maintenance therapy for patients with Crohn's disease without fistulas. It is not known whether infliximab is an effective maintenance therapy for patients with fistulas.METHODS:We performed a multicenter, double-blind, randomized, placebo-controlled trial to evaluate the efficacy of infliximab maintenance therapy in 306 adult patients with Crohn's disease and one or more draining abdominal or perianal fistulas of at least three months' duration. Patients received 5 mg of infliximab per kilogram of body weight intravenously on weeks 0, 2, and 6. A total of 195 patients who had a response at weeks 10 and 14 and 87 patients who had no response were then randomly assigned to receive placebo or 5 mg of infliximab per kilogram every eight weeks and to be followed to week 54. The primary analysis was the time to the loss of response among patients who had a response at week 14 and underwent randomization.RESULTS:The time to loss of response was significantly longer for patients who received infliximab maintenance therapy than for those who received placebo maintenance (more than 40 weeks vs. 14 weeks, P