Infliximab, Azathioprine, or Combination Therapy for Crohn's Disease.
Infliximab, Azathioprine, or Combination Therapy for Crohn's Disease.
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DOI：
10.1056/nejmoa0904492
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发表时间：
2010-04-15
影响因子：
158.5
通讯作者：
Rutgeerts, Paul
中科院分区：
文献类型：
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作者：
Colombel, Jean Frederic;Sandborn, William J.;Rutgeerts, Paul
背景：英夫利昔单抗和硫唑嘌呤单独或联合治疗克罗恩病的疗效和安全性比较尚不清楚。方法：在这项随机、双盲试验中，我们在 508 名既往未接受过免疫抑制治疗的中重度克罗恩病成人中评估了英夫利昔单抗单药治疗、硫唑嘌呤单药治疗以及两种药物联合治疗的疗效 或生物治疗。患者被随机分配接受第0、2和6周每公斤体重5毫克英夫利昔单抗的静脉输注，然后每8周一次加每日口服安慰剂胶囊；每日每公斤口服 2.5 毫克硫唑嘌呤，并按标准时间表输注安慰剂；或两种药物联合治疗。患者在第 30 周接受研究药物治疗，并可以继续进行盲法研究扩展至第 50 周。 结果：在接受联合治疗的 169 名患者中，96 名患者 (56.8%) 在第 26 周（主要终点）达到无皮质类固醇临床缓解，而单独接受英夫利昔单抗治疗的 169 名患者中有 75 名患者 (44.4%) (P=0.02)，170 名患者中有 51 名患者(30.0%) 接收 单独使用硫唑嘌呤（P
Background: The comparative efficacy and safety of infliximab and azathioprine therapy alone or in combination for Crohn's disease are unknown.Methods: In this randomized, double-blind trial, we evaluated the efficacy of infliximab monotherapy, azathioprine monotherapy, and the two drugs combined in 508 adults with moderate-to-severe Crohn's disease who had not undergone previous immunosuppressive or biologic therapy. Patients were randomly assigned to receive an intravenous infusion of 5 mg of infliximab per kilogram of body weight at weeks 0, 2, and 6 and then every 8 weeks plus daily oral placebo capsules; 2.5 mg of oral azathioprine per kilogram daily plus a placebo infusion on the standard schedule; or combination therapy with the two drugs. Patients received study medication through week 30 and could continue in a blinded study extension through week 50.Results: Of the 169 patients receiving combination therapy, 96 (56.8%) were in corticosteroid-free clinical remission at week 26 (the primary end point), as compared with 75 of 169 patients (44.4%) receiving infliximab alone (P=0.02) and 51 of 170 patients (30.0%) receiving azathioprine alone (P