Department of Clinical and Experimental Sciences, University of Brescia, Bone Marrow Transplant Unit, ASST-Spedali Civili di Brescia, 25123 Brescia, Italy.
Dietetics and Clinical Nutrition Unit, ASST-Spedali Civili Brescia, 25123 Brescia, Italy.
Nutrients. 2022 Aug 31;14(17):3589. doi: 10.3390/nu14173589.
Malnutrition is common after allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT), and interventions directed to correct nutritional status are warranted to improve transplant outcomes. In this prospective study, an oral polymeric formulation enriched with TGF-β2 (TE-OPF) was explored to correct malnutrition according to Patient-Generated Subjective Global Assessment (PG-SGA). TE-OPF was proposed to 51 consecutive patients who received transplants at our institution for hematological malignancies, and sufficient dose intake was established per protocol as at least 50% of the prescribed dose of TE-OPF: group A received adequate nutritional support; group B, inadequate. The study met the primary outcomes in terms of safety (no adverse events reported during TE-OPF intake except for its disgusting taste) and malnutrition (PG-SGA C 28 days after transplant): severely malnourished patients (PG-SGA C) accounted for 13% in group A and 88.9% in group B ( = 0.000). At the end of the study, after a median follow-up of 416 days, the estimated median Overall Survival (OS) was 734 days for well or moderately nourished patients (PG-SGA A/B) in comparison to 424 for malnourished patients ( = 0.03). Inadequate TE-OPF intake was associated with an increase in acute gastrointestinal Graft Versus Host Disease (GVHD) cumulative incidence (38% vs. 0% = 0.006). A higher incidence of pneumonia was reported in group B ( = 0.006). IGF-1 levels at 14 and 28 days after transplant were significantly higher in group A and were associated with a lower incidence of acute GVHD (aGVHD). Higher subsets of B, T, and NK cells were found in group A, and a higher number of CD16+ NK cells was associated with a lower incidence of acute GVHD ( = 0.005) and increased survival at the end of the study ( = 0.023). Artificial neural network analysis suggested that inadequate TE-OPF intake, pneumonia, and sepsis significantly affected malnutrition 28 days after alloHSCT and survival 365 days after alloHSCT (normalized importance 100%, 82%, and 68%, respectively). In this exploratory and preliminary study, the use of TE-OPF appeared to reduce the incidence of malnutrition after alloHSCT, but larger and controlled studies are required.
异基因造血干细胞移植（alloHSCT）后常发生营养不良，有必要采取干预措施纠正营养状况，以改善移植结局。在这项前瞻性研究中，根据患者生成的主观整体评估（PG-SGA），探索了一种富含 TGF-β2 的口服聚合物配方（TE-OPF）来纠正营养不良。TE-OPF 被提议用于在我院接受血液系统恶性肿瘤移植的 51 例连续患者，根据方案确定了足够的剂量摄入，即至少摄入 TE-OPF 规定剂量的 50%：A 组接受充分的营养支持；B 组，不充分。该研究在安全性方面达到了主要终点（除了令人恶心的味道外，TE-OPF 摄入期间没有报告任何不良事件）和营养不良（移植后 28 天的 PG-SGA C）：A 组严重营养不良患者（PG-SGA C）占 13%，B 组占 88.9%（= 0.000）。在研究结束时，中位随访 416 天后，营养良好或中度营养不良患者（PG-SGA A/B）的中位总生存（OS）估计为 734 天，而营养不良患者为 424 天（= 0.03）。TE-OPF 摄入不足与急性胃肠道移植物抗宿主病（GVHD）累积发生率增加相关（38% vs. 0%= 0.006）。B 组报告肺炎发生率较高（= 0.006）。移植后 14 天和 28 天 IGF-1 水平在 A 组显著升高，与急性 GVHD 发生率较低相关（aGVHD）。A 组发现 B、T 和 NK 细胞的更高亚群，CD16+NK 细胞数量较多与急性 GVHD 发生率较低（= 0.005）和研究结束时生存增加相关（= 0.023）。人工神经网络分析表明，TE-OPF 摄入不足、肺炎和败血症显著影响 alloHSCT 后 28 天的营养不良和 alloHSCT 后 365 天的生存（归一化重要性分别为 100%、82%和 68%）。在这项探索性和初步研究中，使用 TE-OPF 似乎可以降低 alloHSCT 后营养不良的发生率，但需要更大规模和对照的研究。
