Ginard Daniel, Barreiro-de Acosta Manuel, Nos Pilar, Moraleja Irene, Muñoz Nuñez Fernando, Aldeguer Xavier, Echarri Ana, Villoria Albert, Riestra Sabino, Boscá Watts Marta Maia, González-Lama Yago, Royo Vanesa, Ferreiro-Iglesias Rocío, Iborra Marisa, Elorza Ainara, Fernandez-Pordomingo Alejandra, Sans Miquel
Gastroenterology Unit, Hospital Universitario Son Espases, Instituto de Investigación Sanitaria Illes Balears, Palma de Mallorca, Spain.
Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain.
Dig Dis. 2024;42(6):600-609. doi: 10.1159/000540792. Epub 2024 Aug 22.
Identifying novel treatment strategies for patients with ulcerative colitis (UC) and at risk of relapse is critical. The objective of this study was to assess the efficacy of beclomethasone dipropionate (BDP) in lowering fecal calprotectin (FC) levels in UC patients in clinical remission and at risk of relapse.
This multicenter study comprised a double-blind, randomized, placebo-controlled phase (part I) and an open-label, non-randomized phase (part II). Eligible participants with UC in clinical remission treated with 5-aminosalicylic acid and with FC levels ≥250 μg/g were randomized to receive 5 mg/day of BDP or placebo for 4 weeks (part I). At week 5, patients with FC ≥100 μg/g were treated with 5 mg/day of BDP for 4 weeks (part II), and FC levels were tested at week 9.
Forty-three patients were randomized: 22 received BDP (group A) and 21 placebo (group B). At week 4, 13 patients (59.1%) in group A and 3 (17.6%) in group B had FC levels <100 μg/g (p value = 0.010). In the double-blind phase of the study, no patient relapsed in group A and 4 in group B (p value = 0.049). Both treatment groups showed a favorable safety profile, with the most common adverse events being gastrointestinal disorders.
In this multicenter, randomized clinical trial including patients with UC in clinical remission but with elevated FC, BDP was efficacious in reducing FC and well-tolerated.
为溃疡性结肠炎（UC）患者及有复发风险的患者确定新的治疗策略至关重要。本研究的目的是评估丙酸倍氯米松（BDP）降低临床缓解且有复发风险的UC患者粪便钙卫蛋白（FC）水平的疗效。
本多中心研究包括双盲、随机、安慰剂对照阶段（第一部分）和开放标签、非随机阶段（第二部分）。符合条件的临床缓解期UC患者，接受5-氨基水杨酸治疗且FC水平≥250μg/g，被随机分配接受5mg/天的BDP或安慰剂治疗4周（第一部分）。在第5周时，FC≥100μg/g的患者接受5mg/天的BDP治疗4周（第二部分），并在第9周检测FC水平。
43例患者被随机分组：22例接受BDP（A组），21例接受安慰剂（B组）。在第4周时，A组13例患者（59.1%）和B组3例患者（17.6%）的FC水平<100μg/g（p值=0.010）。在研究的双盲阶段，A组无患者复发，B组有4例复发（p值=0.049）。两个治疗组的安全性均良好，最常见的不良事件为胃肠道疾病。
在这项多中心随机临床试验中，纳入了临床缓解但FC升高的UC患者，BDP在降低FC方面有效且耐受性良好。
