Intravenous Albumin Infusion Does not Augment the Response Rate to a Combination of Exclusive Enteral Nutrition and Intravenous Steroids in Acute Severe Ulcerative Colitis: A Randomised Controlled Trial.
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Abstract
Introduction: Overall, 30-40% patients with acute severe ulcerative colitis [ASUC] fail intravenous [IV] steroids, requiring medical rescue therapy/colectomy. Low baseline albumin predicts steroid non-response, and exclusive enteral nutrition [EEN] has been shown to improve steroid response and albumin levels. Albumin infusion, due to its anti-inflammatory and antioxidant properties, might further improve steroid response in ASUC, which was evaluated in the present study.
Methods: In this open-label, randomised, controlled trial, patients with ASUC were randomised in 1:1 ratio to either albumin + standard of care [SOC] + EEN [Albumin arm] or SOC + EEN [SOC arm], over January 2021-February 2023. Both arms received 5 days of EEN with 400 mg IV hydrocortisone/day. Patients in the Albumin arm were administered 5 days of 20% weight/volume [w/v] intravenous albumin [100 ml]. Primary outcome was first, steroid failure [need for rescue medical therapy or colectomy] and second, proportion of patients with adverse events.
Results: In all, 61 patients [albumin: 30, SOC: 31][mean age 31.6 ± 0.4 years, male 57.4%], were included. Baseline characteristics were comparable. There was no difference in steroid failure between Albumin and SOC arms (10/30 [33.33%] vs 13/31[41.94%], p = 0.49). No adverse events were reported with albumin infusions. Colectomy rate [10% vs 9.68%, p = 1], response to salvage medical therapy [88.89% vs 76.92%, p = 0.62] and median [interquartile range] duration of hospitalisation [10.5 [7-16] vs 10 [7-20], p = 0.43] were also comparable. The long-term composite outcome of colectomy and re-admission rates was numerically higher in the Albumin than the SOC arm [37.04% vs 17.86%, p > 0.05], although this did not reach statistical significance.
Conclusion: There was no benefit of intravenous albumin infusion as an adjunct to IV steroids and EEN in patients with ASUC.
简介30-40% 的急性重度溃疡性结肠炎（ASUC）患者静脉注射类固醇（IV）无效，需要进行药物抢救治疗/切除术。低基线白蛋白可预测类固醇无反应，而纯肠道营养（EEN）已被证明可改善类固醇反应和白蛋白水平。由于白蛋白具有抗炎和抗氧化特性，因此输注白蛋白可进一步改善 ASUC 的类固醇反应，本研究对此进行了评估：在这项开放标签随机对照试验中，ASUC患者按1:1的比例被随机分为白蛋白+标准护理（SOC）+EEN与SOC+EEN两组（2021年1月至2023年2月）。两组患者均接受了为期5天的EEN治疗，同时静脉滴注400毫克氢化可的松/天。白蛋白治疗组患者接受为期 5 天的 20% w/v 静脉注射白蛋白（100 毫升）。主要结果为：1）类固醇治疗失败（需要进行抢救性药物治疗或结肠切除术）；2）出现不良反应的患者比例：共纳入 61 例患者（白蛋白-30 例，SOC-31 例）（平均年龄（31.6±0.4）岁，男性-57.4%）。基线特征具有可比性。白蛋白治疗组和 SOC 治疗组的类固醇治疗失败率没有差异（10/30（33.33%） vs 13/31（41.94%），P=0.49）。白蛋白输注未出现不良反应。结肠切除率（10% vs 9.68%，P=1）、对挽救性药物治疗的反应（88.89% vs 76.92%，P=0.62）和中位住院时间（10.5(7-16) vs 10(7-20)，P=0.43）也相当。白蛋白治疗组的结肠切除术和再入院率的长期综合结果在数字上高于SOC治疗组（37.04% vs 17.86%，P>0.05），但未达到统计学意义：结论：对于 ASUC 患者，静脉输注白蛋白作为静脉类固醇和 EEN 的辅助治疗并无益处。
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