Tita Georgia Valentina Tartamus, Serban Daniela Elena, Chiperi Lacramioara Eliza, Fogas Cristina Rebeca, Medan Stefana Arlinda, Tantau Vasile Marcel
3 Medical Clinic, Department of Internal Medicine, Iuliu Hatieganu University of Medicine and Pharmacy Cluj-Napoca, Romania.
Department of Mother and Child, 2 Clinic of Pediatrics, Iuliu Hatieganu University of Medicine and Pharmacy, Emergency Clinical Hospital for Children, Cluj-Napoca, Romania.
Med Pharm Rep. 2025 Jul;98(3):371-380. doi: 10.15386/mpr-2900. Epub 2025 Jul 30.
Exclusive enteral nutrition (EEN) is a well-established first-line therapy for inducing remission in mild-to-moderate pediatric Crohn's disease (pCD). While clinical remission (CR) and mucosal healing (MH) are widely accepted therapeutic goals, the concept of transmural healing (TH) has gained increasing recognition. This study aimed to evaluate the effectiveness of EEN in pCD patients from Romania, focusing on nutritional status, remission outcomes, and the impact of various factors on treatment efficacy.
We conducted a retrospective observational study of pCD consecutive patients who received EEN for induction of remission between 2007 and 2017 at a referral center in Cluj-Napoca, Romania. CR was defined as a weighted Pediatric Crohn's Disease Activity Index (wPCDAI) <12.5, MH as a fecal calprotectin level <250 microg/g, and TH as the combination of MH and imagistic remission assessed by intestinal ultrasonography. Statistical analyses included descriptive and comparative approaches, including logistic regression, with p <0.05 considered significant.
Twenty patients with pCD, representing 45% of the cohort, were included. The median age at diagnosis was 14.2 years (9.9-18.4), and 65% were male. EEN was administered with a mean duration of 7.84±1.26 weeks. Body mass index Z-scores significantly improved following EEN (p=0.02). Hypoalbuminemia, detected in 55% of patients at diagnosis, resolved completely after EEN (p=0.00015). CR was achieved in 82% of patients with active clinical disease, MH in 26% of patients with microscopic activity, and TH in 20% of patients with imagistic activity. Age at diagnosis, disease behavior, location, activity, and anti-Saccharomyces cerevisiae antibody status were not significantly associated with CR or MH. Disease activity at initiation, measured by the wPCDAI, was inversely associated with TH (p=0.004).
This is the first study to report on EEN outcomes in pCD patients from Romania. EEN was effective in improving nutritional status and inducing CR, while MH was achieved in about one-quarter of patients. TH was also observed, though less frequently, and was negatively associated with higher baseline clinical disease activity. Regional factors may have influenced these outcomes.
全肠内营养（EEN）是诱导轻至中度儿童克罗恩病（pCD）缓解的一种成熟的一线治疗方法。虽然临床缓解（CR）和黏膜愈合（MH）是广泛认可的治疗目标，但透壁愈合（TH）的概念也越来越受到重视。本研究旨在评估EEN对罗马尼亚pCD患者的疗效，重点关注营养状况、缓解结果以及各种因素对治疗效果的影响。
我们对2007年至2017年期间在罗马尼亚克卢日-纳波卡的一家转诊中心接受EEN诱导缓解的连续性pCD患者进行了一项回顾性观察研究。CR定义为加权儿童克罗恩病活动指数（wPCDAI）<12.5，MH定义为粪便钙卫蛋白水平<250μg/g，TH定义为MH与通过肠道超声评估的影像学缓解的结合。统计分析包括描述性和比较性方法，包括逻辑回归，p<0.05被认为具有统计学意义。
纳入了20例pCD患者，占队列的45%。诊断时的中位年龄为14.2岁（9.9 - 18.4岁），65%为男性。EEN的平均给药持续时间为7.84±1.26周。EEN后体重指数Z评分显著改善（p = 0.02）。诊断时55%的患者检测到低白蛋白血症，EEN后完全缓解（p = 0.00015）。82%有活动性临床疾病的患者实现了CR，26%有微观活动的患者实现了MH，20%有影像学活动的患者实现了TH。诊断时的年龄、疾病行为、部位、活动度和抗酿酒酵母抗体状态与CR或MH无显著相关性。起始时的疾病活动度，通过wPCDAI测量，与TH呈负相关（p = 0.004）。
这是第一项报道罗马尼亚pCD患者EEN治疗结果的研究。EEN在改善营养状况和诱导CR方面有效，约四分之一的患者实现了MH。也观察到了TH，尽管频率较低，且与较高的基线临床疾病活动度呈负相关。区域因素可能影响了这些结果。
