Lachman Dan, Orlanski-Meyer Esther, Lev-Tzion Raffi, Ledder Oren, Assa Amit, Shavit-Brunschwig Zivia, Yerushalmi Baruch, Aloi Marina, Griffiths Anne M, Albenberg Lindsey, Bar-Or Itzhak, Kolho Kaija-Leena, Shouval Dror S, Cohen Shlomi, Turner Dan, Atia Ohad
Juliet Keidan Institute of Pediatric Gastroenterology and Nutrition, The Eisenberg R&D Authority, Shaare Zedek Medical Center, The Hebrew University of Jerusalem, Jerusalem, Israel.
Pediatric Gastroenterology Unit, Soroka University Medical Center and Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.
J Pediatr Gastroenterol Nutr. 2025 Mar;80(3):433-439. doi: 10.1002/jpn3.12442. Epub 2024 Dec 24.
The PRASCO trial reported the short-term superiority of an antibiotic cocktail plus intravenous corticosteroids (IVCS) over IVCS alone in children with acute severe colitis (ASC). Here, we report the extension of the PRASCO trial and the long-term outcomes of the antibiotic cocktail in ASC.
This prospective follow-up of the PRASCO trial documented disease outcomes and treatments annually through 5 years. The primary outcome was colectomy, and the secondary outcome was escalation to biologics, analyzed descriptively.
A total of 26 children were included (12 receiving IVCS and 14 receiving IVCS + antibiotics), 19% of whom underwent colectomy during the follow-up period. The estimated probability of colectomy at 3, 6, and 12 months from admission were 7.1%, 7.1%, and 21% with IVCS + antibiotics and 0%, 8.3%, and 17% with IVCS. No children required colectomy after the first year of follow-up. The estimated probability of escalating to biologics were 66%, 77%, and 77% after 1, 2, and 3 years with IVCS + antibiotics and 42%, 51%, and 76% with IVCS. Clinical remission was higher in the IVCS + antibiotics group at each timepoint (e.g., 30% vs. 11% at 5-years). Delta of Pediatric Ulcerative Colitis Activity Index (PUCAI) score from baseline to day three of admission predicted future escalation to biologics (area under curves (AUC) 0.84 [95%CI 0.59-1.0]).
While adding antibiotics to IVCS may provide better short-term outcomes, the long-term benefits were comparable to IVCS alone. At 5 years, about one-fifth of children had undergone colectomy, and almost four-fifths had escalated to biologics, particularly during the first year after admission.
PRASCO试验报告了抗生素鸡尾酒联合静脉注射皮质类固醇(IVCS)在急性重症结肠炎(ASC)儿童中比单纯IVCS具有短期优势。在此,我们报告PRASCO试验的扩展情况以及抗生素鸡尾酒在ASC中的长期结局。
对PRASCO试验进行这项前瞻性随访,每年记录疾病结局和治疗情况,为期5年。主要结局是结肠切除术,次要结局是升级至生物制剂,进行描述性分析。
共纳入26名儿童(12名接受IVCS,14名接受IVCS + 抗生素),其中19%在随访期间接受了结肠切除术。入院后3个月、6个月和12个月时,IVCS + 抗生素组结肠切除术的估计概率分别为7.1%、7.1%和21%,IVCS组分别为0%、8.3%和17%。随访第一年之后没有儿童需要进行结肠切除术。IVCS + 抗生素组在1年、2年和3年后升级至生物制剂的估计概率分别为66%、77%和77%,IVCS组分别为42%、51%和76%。IVCS + 抗生素组在每个时间点的临床缓解率更高(例如,5年时为30%对11%)。从基线到入院第3天的小儿溃疡性结肠炎活动指数(PUCAI)评分变化可预测未来升级至生物制剂的情况(曲线下面积(AUC)为0.84 [95%CI 0.59 - 1.0])。
虽然在IVCS中添加抗生素可能会带来更好的短期结局,但长期益处与单纯IVCS相当。5年后,约五分之一的儿童接受了结肠切除术,近五分之四的儿童升级至生物制剂,尤其是在入院后的第一年。