英夫利西治疗活动性溃疡性结肠炎疗效与安全性的临床研究

The safety and efficacy of infliximab in patients with active ulcerative colitis in China

目的 本研究旨在为英夫利西单抗治疗中国中重度活动性溃疡性结肠炎患者的疗效和安全性提供证据.方法 一项随机、双盲、安慰剂对照研究.入组的中重度活动性溃疡性结肠炎患者按1∶1随机分配并接受静脉输注5 mg/kg英夫利西单抗或安慰剂治疗,疗程26周.结果 12个中心共99例患者随机分为英夫利西单抗组(n=50)或安慰剂组(n=49).与安慰剂组比较,英夫利西单抗组第8周临床应答率[n=32(64%) vs.n=16(33%);P=0.002 1]和黏膜愈合率[n=17(34%) vs.n=8(16%);P=0.045 1]更高,第26周的临床缓解率更高[n=14 (28%) vs.n=5 (10%);P=0.028 1].研究期间未发生药物相关的严重不良事件.结论 5 mg/ kg英夫利西单抗治疗中-重度溃疡性结肠炎是安全有效的.

Objective Infliximab is effective and safe for the treatment of ulcerative colitis in Western populations.The aim of this study was to evaluate the efficacy and safety of infliximab in patients with mo derate-to-severe active ulcerative colitis in multiple centers in China.Methods This was a randomized,double-blind,placebo-controlled trial comprising a 26 week study period.Patients with moderate-to-severe active ulcerative colitis received intravenous infliximab 5 mg/kg or placebo in a 1:1 ratio.Results Across 12 centers in China,participants(n=99)were randomized to receive either infliximab(n=50)or placebo(=49).Significantly more palienls in the infliximab group achieved clinical response[n=32(64%)]than placebo[n=16(33%);P=0.002 1]and mucosal healing[n=17(34%)]than placebo[n=8(16%);P=0.045 1]at Week 8 with infliximab,while at Week 26 more infliximab patients[n=14(28%)]achieved clinical remission than placebo[n=5(10%);P=0.028 1].There were no drug-related serious adverse events during the study.Conclusions Infliximab 5 mg/kg was safe and efficacious in Chinese patients with moderate-to-severe ulcerative colitis.