Background

There is a paucity of evidence to support safe and effective management of patients with acute severe ulcerative colitis during the COVID-19 pandemic. We sought to identify alterations to established conventional evidence-based management of acute severe ulcerative colitis during the early COVID-19 pandemic, the effect on outcomes, and any associations with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and severe COVID-19 outcomes.

Methods

The PROTECT-ASUC study was a multicentre, observational, case-control study in 60 acute secondary care hospitals throughout the UK. We included adults (≥18 years) with either ulcerative colitis or inflammatory bowel disease unclassified, who presented with acute severe ulcerative colitis and fulfilled the Truelove and Witts criteria. Cases and controls were identified as either admitted or managed in emergency ambulatory care settings between March 1, 2020, and June 30, 2020 (COVID-19 pandemic period cohort), or between Jan 1, 2019, and June 30, 2019 (historical control cohort), respectively. The primary outcome was the proportion of patients with acute severe ulcerative colitis receiving rescue therapy (including primary induction) or colectomy. The study is registered with ClinicalTrials.gov, NCT04411784.

Findings

We included 782 patients (398 in the pandemic period cohort and 384 in the historical control cohort) who met the Truelove and Witts criteria for acute severe ulcerative colitis. The proportion of patients receiving rescue therapy (including primary induction) or surgery was higher during the pandemic period than in the historical period (217 [55%] of 393 patients vs 159 [42%] of 380 patients; p=0·00024) and the time to rescue therapy was shorter in the pandemic cohort than in the historical cohort (p=0·0026). This difference was driven by a greater use of rescue and primary induction therapies with biologicals, ciclosporin, or tofacitinib in the COVID-19 pandemic period cohort than in the historical control period cohort (177 [46%] of 387 patients in the COVID-19 cohort vs 134 [36%] of 373 patients in the historical cohort; p=0·0064). During the pandemic, more patients received ambulatory (outpatient) intravenous steroids (51 [13%] of 385 patients vs 19 [5%] of 360 patients; p=0·00023). Fewer patients received thiopurines (29 [7%] of 398 patients vs 46 [12%] of 384; p=0·029) and 5-aminosalicylic acids (67 [17%] of 398 patients vs 98 [26%] of 384; p=0·0037) during the pandemic than in the historical control period. Colectomy rates were similar between the pandemic and historical control groups (64 [16%] of 389 vs 50 [13%] of 375; p=0·26); however, laparoscopic surgery was less frequently performed during the pandemic period (34 [53%] of 64] vs 38 [76%] of 50; p=0·018). Five (2%) of 253 patients tested positive for SARS-CoV-2 during hospital treatment. Two (2%) of 103 patients re-tested for SARS-CoV-2 during the 3-month follow-up were positive 5 days and 12 days, respectively, after discharge from index admission. Both recovered without serious outcomes.

Interpretation

The COVID-19 pandemic altered practice patterns of gastroenterologists and colorectal surgeons in the management of acute severe ulcerative colitis but was associated with similar outcomes to a historical cohort. Despite continued use of high-dose corticosteroids and biologicals, the incidence of COVID-19 within 3 months was low and not associated with adverse COVID-19 outcomes.

Funding

None.

中文翻译：

---

COVID-19 大流行期间急性重症溃疡性结肠炎患者的评估、内镜检查和治疗 (PROTECT-ASUC)：一项多中心、观察性、病例对照研究

背景

缺乏证据支持在 COVID-19 大流行期间对急性重症溃疡性结肠炎患者进行安全有效的管理。我们试图确定早期 COVID-19 大流行期间急性重症溃疡性结肠炎常规循证管理的变化、对结果的影响以及与严重急性呼吸系统综合症冠状病毒 2 (SARS-CoV-2) 感染和严重COVID-19 结果。

方法

PROTECT-ASUC 研究是一项多中心、观察性、病例对照研究，在英国 60 家急症二级护理医院开展。我们纳入了患有溃疡性结肠炎或未分类炎症性肠病的成人（≥18 岁），他们表现为急性重度溃疡性结肠炎并符合 Truelove 和 Witts 标准。病例和对照被确定为在 2020 年 3 月 1 日至 2020 年 6 月 30 日（COVID-19 大流行期间队列）或 2019 年 1 月 1 日至 2019 年 6 月 30 日（历史对照）队列），分别。主要结局是接受抢救治疗（包括初次诱导）或结肠切除术的急性重症溃疡性结肠炎患者的比例。该研究已在 ClinicalTrials.gov 注册，NCT04411784。

发现

我们纳入了符合 Truelove 和 Witts 急性重症溃疡性结肠炎标准的 782 名患者（大流行期间队列中有 398 名，历史对照组中有 384 名）。大流行期间接受抢救治疗（包括初次诱导）或手术的患者比例高于历史时期（393 名患者中的 217 [55%] vs 380 名患者中的 159 [42%]；p=0·00024）大流行队列中挽救治疗的时间比历史队列短 (p=0·0026)。这种差异是由于在 COVID-19 大流行期间队列中使用生物制品、环孢菌素或托法替尼的挽救和主要诱导疗法比在历史对照期间队列中更多（COVID-19 中 387 名患者中的 177 名 [46%]）队列对比历史队列中 373 名患者中的 134 名 [36%]；p=0·0064）。在大流行期间，更多的患者接受门诊（门诊）静脉内类固醇（385 名患者中的 51 [13%] 对360名患者中的 19 [5%]；p=0·00023）。更少的患者接受硫嘌呤（398 名患者中的 29 [7%] vs 384 名患者中的 46 [12%]；p=0·029）和 5-氨基水杨酸（398 名患者中的 67 [17%] vs 384 名患者中的 98 [26%] ; p=0·0037) 在大流行期间比在历史控制期间。大流行病对照组和历史对照组的结肠切除率相似（389 人中的 64 人 [16%]对375 人中的 50 人 [13%]；p=0·26）；然而，在大流行期间进行腹腔镜手术的频率较低（34 [53%] of 64] vs50 个中的 38 个 [76%]；p=0·018）。253 名患者中有 5 名 (2%) 在住院治疗期间检测出 SARS-CoV-2 阳性。在 3 个月的随访期间对 SARS-CoV-2 进行重新检测的 103 名患者中有两名（2%）分别在入院出院后 5 天和 12 天呈阳性。两人都康复了，但没有出现严重后果。

解释

COVID-19 大流行改变了胃肠病学家和结直肠外科医生治疗急性重症溃疡性结肠炎的实践模式，但与历史队列的结果相似。尽管继续使用大剂量皮质类固醇和生物制剂，但 3 个月内 COVID-19 的发生率很低，并且与 COVID-19 的不良结果无关。

资金

没有任何。