King's College London, School of Immunology & Microbial Sciences, London, UK.
INFINY Institute, Nancy University Hospital Center, Vandœuvre-lès-Nancy, France.
Gut. 2024 Sep 9;73(10):1763-1773. doi: 10.1136/gutjnl-2024-332489.
Acute severe ulcerative colitis (ASUC), characterised by bloody diarrhoea and systemic inflammation, is associated with a significant risk of colectomy and a small risk of mortality. The landmark trial of cortisone in 1955 was pivotal for two reasons: first, for establishing the efficacy of a drug that remains a first-line therapy today and, second, for producing the first set of disease severity criteria and clinical trial endpoints that shaped the subsequent ASUC trial landscape. Trials in the 1990s and at the turn of the millennium established the efficacy of infliximab and ciclosporin, but since then, there has been little progress in drug development for this high-risk population. This systematic review evaluates all interventional randomised controlled trials (RCTs) conducted in patients hospitalised with severe UC. It provides an overview of the efficacy of treatments from past to present and assesses the evolution of trial characteristics with respect to study populations, eligibility criteria and study designs over time. This review details ongoing RCTs in this field and provides a perspective on the challenges for future clinical trial programmes and how these can be overcome to help deliver novel ASUC therapies.
急性重度溃疡性结肠炎（ASUC）的特征是血性腹泻和全身炎症，与结肠切除术的高风险和小死亡率相关。1955 年皮质类固醇的标志性试验具有两个重要意义：首先，它确立了一种药物的疗效，这种药物至今仍是一线治疗药物；其次，它产生了第一组疾病严重程度标准和临床试验终点，这些标准和终点塑造了随后的 ASUC 临床试验格局。20 世纪 90 年代和千年之交的试验确立了英夫利昔单抗和环孢素的疗效，但此后，针对这一高风险人群的药物开发几乎没有进展。本系统评价评估了所有在因重度 UC 住院的患者中进行的干预性随机对照试验（RCT）。它概述了过去和现在治疗方法的疗效，并评估了随着时间的推移，研究人群、入选标准和研究设计方面的试验特征演变。本综述详细介绍了该领域正在进行的 RCT，并就未来临床试验计划的挑战以及如何克服这些挑战提供了一个视角，以帮助提供新型 ASUC 治疗方法。
