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

被引：19

作者：

陈白莉 ^{[1
]}

钱家鸣 ^{[2
]}

吴开春 ^{[3
]}

盛剑秋 ^{[4
]}

许建明 ^{[5
]}

冉志华 ^{[6
]}

袁耀宗 ^{[7
]}

王化虹 ^{[8
]}

陈志芬 ^{[9
]}

李兆申 ^{[10
]}

唐承薇 ^{[11
]}

侯晓华 ^{[12
]}

侯妍妍 ^{[13
]}

陈旻湖 ^{[1
]}

胡品津 ^{[1
]}

机构：

[1] 广州, 中山大学附属第一医院消化内科

[2] 北京协和医院消化内科

[3] 西京医院消化内科

[4] 陆军总医院消化内科

[5] 安徽医科大学第一附属医院消化内科

[6] 上海交通大学附属仁济医院消化内科

[7] 上海交通大学医学院瑞金医院消化内科

[8] 北京大学第一医院消化内科

[9] 武汉大学中南医院消化内科

[10] 上海长海医院消化内科

[11] 四川大学华西医院消化内科

[12] 华中科技大学同济医学院附属协和医院消化内科

[13] 西安杨森统计科学决策部

来源：

中华炎性肠病杂志 | 2017年 / 1卷 / 01期

关键词：

溃疡性结肠炎; 英夫利西单抗; 中国人群;

D O I：

暂无

中图分类号：

R574.62 [结肠疾病];

学科分类号：

100201 [内科学];

摘要：

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。

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