Morello Enrico, Brambilla Giulia, Bernardi Simona, Villanacci Vincenzo, Carlessi Michela, Farina Mirko, Radici Vera, Samarani Emanuela, Pellizzeri Simone, Polverelli Nicola, Leoni Alessandro, Andreoli Marco, Arena Francesco, Ricci Chiara, Malagola Michele, Russo Domenico
Department of Clinical and Experimental Sciences, University of Brescia, Bone Marrow Transplant Unit, ASST-Spedali Civili di Brescia, 25123 Brescia, Italy.
Department of Clinical and Experimental Sciences, University of Brescia, Bone Marrow Transplant Unit, ASST-Spedali Civili di Brescia, 25123 Brescia, Italy.
Transpl Immunol. 2023 Dec;81:101954. doi: 10.1016/j.trim.2023.101954. Epub 2023 Nov 4.
Malnutrition in allogeneic stem cell transplant (allo-SCT) is associated with poor outcomes. Supplementation with Foods for Special Medical Purposes may be a valid alternative to enteral nutrition or total parental nutrition to reduce malnutrition in allo-SCT. In this study, 133 patients consecutively allo-transplanted were assessed for nutritional status by Patient- Generated Subjective Global Assessment (PG-SGA) and supplemented with TGF-beta enriched Food for Special Medical Purposes (TGF-FSMP). PG-SGA, gold standard for nutritional assessment in oncologic patients, was assessed at admission and on day 0, +7, +14, +21, and + 28 from transplant and categorized as follows: A = good nutritional status; B = moderate malnutrition; C = severe malnutrition. TGF-FSMP (Modulen-IBD) is currently used in Inflammatory Bowel Diseases (IBD) as primary nutritional support and in this study the dose was calculated according to BMI and total daily energy expenditure (TDEE). The patients assuming ≥50% of the prescribed TGF-FSMP dose were classified in Group A; the patients who received < 50% were included in Group B per protocol. The primary endpoint of the study was the assessment of the malnourished patients in Group A and B at day+28 after transplantation, according to the criteria of PG-SGA C categorization. At day +28 after transplant: i) patients in Group A were significantly less severely malnourished than patients in the Group B (21/76,28% vs 42/53, 79% respectively, OR 2.86 - CI 1.94-4.23 -, p = 0.000); ii) the incidence of severe (MAGIC II-IV) aGVHD and of any grade gastrointestinal (GI) aGVHD was higher in Group B than in Group A, (43% vs 21% p = 0.003) and (34.5% vs 9.2% p = 0.001); iii) Pneumonia was more frequent in the malnourished patients of Group B than in well/moderate nourished patients of Group A (52.7% vs 27.6% p = 0.002). In group A parenteral nutrition was avoided more frequently than in group B (67.5% vs 33.3% p = 0.000) and a median hospital stay of 27 days in comparison to 32 was reported (p = 0.006). The estimated median overall survival (OS) of the population was 33 months in Group A and 25.1 months in group B (p = 0.03). By multivariate and ANN analysis, TGF-FSMP TR < 50% assumption was significantly correlated with malnutrition, severe and GI aGVHD, pneumonia and reduced OS.
异基因干细胞移植（allo-SCT）中的营养不良与不良预后相关。补充特殊医学用途食品可能是肠内营养或全胃肠外营养的有效替代方案，以减少allo-SCT中的营养不良。在本研究中，通过患者主观整体评定法（PG-SGA）对133例连续接受allo移植的患者进行营养状况评估，并补充富含转化生长因子-β的特殊医学用途食品（TGF-FSMP）。PG-SGA是肿瘤患者营养评估的金标准，在入院时以及移植后第0、+7、+14、+21和+28天进行评估，并分类如下：A = 营养状况良好；B = 中度营养不良；C = 重度营养不良。TGF-FSMP（Modulen-IBD）目前用于炎症性肠病（IBD）作为主要营养支持，在本研究中，剂量根据体重指数（BMI）和每日总能量消耗（TDEE）计算。摄入规定TGF-FSMP剂量≥50%的患者归入A组；根据方案，接受<50%剂量的患者纳入B组。本研究的主要终点是根据PG-SGA C分类标准，评估移植后第28天A组和B组中的营养不良患者。移植后第28天：i）A组患者的重度营养不良程度明显低于B组患者（分别为21/76，28% 对42/53，79%，OR 2.86 - CI 1.94 - 4.23 -，p = 0.000）；ii）B组中重度（MAGIC II-IV）急性移植物抗宿主病（aGVHD）和任何级别的胃肠道（GI）aGVHD的发生率高于A组，（43% 对21%，p = 0.003）和（34.5% 对9.2%，p = 0.001）；iii）B组营养不良患者的肺炎发生率高于A组营养良好/中度营养患者（52.7% 对27.6%，p = 0.002）。与B组相比，A组更频繁地避免了肠外营养（67.5% 对33.3%，p = 0.000），并且报告的中位住院时间为27天，而B组为32天（p = 0.006）。A组人群的估计中位总生存期（OS）为33个月，B组为25.1个月（p = 0.03）。通过多变量和人工神经网络分析，摄入TGF-FSMP TR < 50%与营养不良、重度和胃肠道aGVHD、肺炎以及总生存期缩短显著相关。
