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.

中文翻译：

---

急性重度溃疡性结肠炎试验：过去、现在和未来


急性严重溃疡性结肠炎 （ASUC） 以血性腹泻和全身炎症为特征，与结肠切除术的显著风险和较小的死亡风险相关。1955 年具有里程碑意义的可的松试验至关重要，原因有两个：首先，确定了一种今天仍然是一线疗法的药物的疗效，其次，产生了第一套疾病严重程度标准和临床试验终点，塑造了随后的 ASUC 试验格局。1990 年代和千禧年之交的试验确定了英夫利昔单抗和环孢素的疗效，但从那时起，针对这一高危人群的药物开发几乎没有进展。本系统评价评估了在重度 UC 住院患者中进行的所有干预性随机对照试验 （RCT）。它概述了从过去到现在的治疗效果，并评估了试验特征在研究人群、资格标准和研究设计方面的演变。本综述详细介绍了该领域正在进行的随机对照试验，并就未来临床试验计划面临的挑战以及如何克服这些挑战以帮助提供新的 ASUC 疗法提供了观点。