Assessment, endoscopy, and treatment in patients with acute severe ulcerative colitis during the COVID-19 pandemic (PROTECT-ASUC): a multicentre, observational, case-control study.
Assessment, endoscopy, and treatment in patients with acute severe ulcerative colitis during the COVID-19 pandemic (PROTECT-ASUC): a multicentre, observational, case-control study.
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DOI：
10.1016/s2468-1253(21)00016-9
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发表时间：
2021-04
期刊：
影响因子：
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通讯作者：
PROTECT-ASUC Study Group
中科院分区：
文献类型：
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作者：
Sebastian S;Walker GJ;Kennedy NA;Conley TE;Patel KV;Subramanian S;Kent AJ;Segal JP;Brookes MJ;Bhala N;Gonzalez HA;Hicks LC;Mehta SJ;Lamb CA;PROTECT-ASUC Study Group
在新冠肺炎大流行期间，缺乏证据支持安全有效地治疗急性重症溃疡性结肠炎患者。我们试图确定在新冠肺炎大流行早期建立的急性严重溃疡性结肠炎常规循证治疗的变化，对预后的影响，以及与严重急性呼吸综合征冠状病毒2(SARS-CoV-2)感染和严重新冠肺炎预后的任何关联。PROTECT-ASUC研究是一项在英国60家急性二级护理医院进行的多中心观察性病例对照研究。我们纳入了患有溃疡性结肠炎或炎症性肠病的成年人(≥18岁)，他们表现为急性严重溃疡性结肠炎，并符合Truelove和Witts标准。病例和对照分别被确定为在2020年3月1日至2020年6月30日(新冠肺炎大流行期间队列)或2019年1月1日至2019年6月30日(历史对照队列)期间在急诊门诊护理环境中入院或管理。主要结果是接受抢救治疗(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。这项研究注册在ClinicalTrials.gov，NCT04411784。我们纳入了782名符合Truelove和Witts急性严重溃疡性结肠炎标准的患者(大流行期间队列中有398名，历史对照队列中有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例患者中217例(55%)对380例患者中159例(42%)；p=0·00024)，大流行队列中的抢救治疗时间比历史队列中的短(p=0.0026)。这一差异是由于在新冠肺炎大流行期间队列中比在历史控制期队列中更多地使用生物制剂、环孢菌素或托法替尼的抢救和初级诱导疗法(新冠肺炎队列中387例患者中177例[46%]，历史队列中373例患者中134[36%]；p=0.0064)。在大流行期间，更多的患者接受了门诊(门诊)静脉注射类固醇(385例患者中51例[13%]，360例患者中19例[5%]；p=0·00023)。在大流行期间，与历史控制期相比，更少的患者接受了硫嘌呤(398名患者中29名[7%]，384名患者中46名[12%]；p=0.029)和5-氨基水杨酸(398名患者中67名[17%]，384名患者中98名[26%]；p=0.0037)。大流行和历史对照组的结肠切除率相似([16%]389比50[13%]375；p=0.26)；然而，在大流行期间进行腹腔镜手术的频率较低(的34[53%]比50的38[76%]；p=0.018)。在253例患者中，有5例(2%)在医院治疗期间检测出SARS-CoV-2呈阳性。103例患者中，2例(2%)在出院后第5天和第12天复查SARS-CoV-2。两人都康复了，没有出现严重后果。新冠肺炎大流行改变了胃肠科医生和结直肠外科医生在治疗急性严重溃疡性结肠炎方面的执业模式，但与历史队列结果相似。尽管继续使用大剂量皮质类固醇和生物制品，但3个月内新冠肺炎的发生率很低，与新冠肺炎的不良结局无关。没有。
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. 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. 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. 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. None.