消化在线: 一项平行、开放标记随机对照试验
来源：
背景：环孢素和英夫利昔单抗是避免静脉注射激素难以治愈的急性重症溃疡性结肠炎患者结肠切除的潜在挽救治疗。
方法：在这项平行的、开放标记、随机对照试验中，患者年龄最小为18岁， 为Lichtiger分数高于10分的急性重症爆发型溃疡性结肠炎患者，给予静脉注射大剂量激素，但治疗不成功，未使用环孢素或英夫利昔单抗治疗。在2007年6月1日至2010年8月31日期间，27个欧洲中心的患者被随机 (通过电脑生成的排列表；1 :1)安排接受静脉注射环孢素(2mg/kg每天，持续1周，随后口服至第98天)或英夫利昔单抗(5mg/kg，在第0天、第14天和第42天给药)。在两组中，对于有临床反应的患者，在第7天开始给予咪唑硫嘌呤。实验终止结果为治疗失败(包括药物治疗7天临床症状无改善、7-98天中出现症状复发、直至第98天仍未出现非激素依赖性的缓解或者是严重的药物副作用导致治疗中止、需结肠切除术或死亡)。采用的是治疗意向分析。这项实验在欧洲临床试验数据库(EudraCT)(2006-005299-42)和美国临床试验数据库(ClinicalTrials.gov)（NCT00542152）注册。
发现：115名患者被随机分配；58名患者接受环孢素，另外57名患者接受英夫利昔单抗。应用环孢素治疗失败率为60%(35人无临床反应)，英夫利昔单抗治疗失败率为54%(31人无临床反应)，两者绝对风险差为6%(95% CI -7 to 19；p=0.52)。环孢素组出现严重不良反应的人数为9人，所占比例为16%，而英夫利昔单抗组共有14人出现严重不良反应，所占比例为25%。
阐释：对于静脉注射激素难以治愈的患有急性溃疡性结肠炎的患者，环孢素并不比英夫利昔单抗更有效。在临床实践中，应该根据医生和治疗中心的经验来选择疗法。
Ciclosporin versus infliximab in patients with severe ulcerative colitis refractory to intravenous steroids: a parallel, open-label randomised controlled trial.
BACKGROUND: Ciclosporin and infliximab are potential rescue treatments to avoid colectomy in patients with acute severe ulcerative colitis refractory to intravenous corticosteroids. We compared the efficacy and safety of these drugs for this indication.
METHODS: In this parallel, open-label, randomised controlled trial, patients were aged at least 18 years, had an acute severe flare of ulcerative colitis defined by a Lichtiger score greater than 10 points, and had been given an unsuccessful course of high-dose intravenous steroids. None of the patients had previously received ciclosporin or infliximab. Between June 1, 2007, and Aug 31, 2010, patients at 27 European centres were randomly assigned (via computer-derived permutation tables; 1:1) to receive either intravenous ciclosporin (2 mg/kg per day for 1 week, followed by oral drug until day 98) or infliximab (5 mg/kg on days 0, 14, and 42). In both groups, azathioprine was started at day 7 in patients with a clinical response. Neither patients nor investigators were masked to study treatment. The primary efficacy outcome was treatment failure defined by absence of a clinical response at day 7, a relapse between day 7 and day 98, absence of steroid-free remission at day 98, a severe adverse event leading to treatment interruption, colectomy, or death. Analysis was by intention to treat. This trial is registered with EudraCT (2006-005299-42) and ClinicalTrials.gov (NCT00542152).
FINDINGS: 115 patients were randomly assigned; 58 patients were allocated to receive ciclosporin and 57 to receive infliximab. Treatment failure occurred in 35 (60%) patients given ciclosporin and 31 (54%) given infliximab (absolute risk difference 6%; 95% CI -7 to 19; p=0?52). Nine (16%) patients in the ciclosporin group and 14 (25%) in the infliximab group had severe adverse events.
INTERPRETATION: Ciclosporin was not more effective than infliximab in patients with acute severe ulcerative colitis refractory to intravenous steroids. In clinical practice, treatment choice should be guided by physician and centre experience.
Ref: T Laharie D, Bourreille A, Branche J, et al. Lancet. 2012 Dec 1;380(9857):1909-15. doi: 10.1016/S0140-6736(12)61084-8. Epub 2012 Oct 10.