Lucchese Alessandra, Matarese Giovanni, Ghislanzoni Luis Huanca, Gastaldi Giorgio, Manuelli Maurizio, Gherlone Enrico
a Department of Orthodontics , Dental School (Dean: Prof. E. Gherlone), Vita-Salute San Raffaele University , Milan , Italy ;
b Research in Dentofacial Orthopedics, Orthodontics and Pediatric Dentistry, Research Area in Oral Pathology and Implantology (Head: Prof. E. Gherlone), IRCCS San Raffaele Hospital , Milan , Italy ;
Leuk Lymphoma. 2016;57(4):820-7. doi: 10.3109/10428194.2015.1081192. Epub 2015 Nov 20.
This randomized-controlled trial studied the efficacy of palifermin, administered as a dose during hematopoietic stem cell transplant (HSCT) therapy, as primary prophylaxis on pediatric patients with acute lymphoblastic leukemia in order to reduce oral mucositis (OM). Patients in the palifermin group were randomly assigned to receive palifermin, 60 μg/kg, intravenously as a single dose 3 days before and 0, +1, and +2 post autologous HSCT infusion. The patients in the control group received only a placebo treatment. OM-related assessments were the WHO oral-toxicity scale and the patient-reported outcomes. There was a statistically significant reduction in the incidence of OM grade 3 and 4 in the palifermin group compared to the control group. There was also a reduction in the degree of severity of OM in the palifermin group (1.65 grade respect to 2.33 in the control group). Palifermin could prevent the recurrence of severe OM and improve the quality of life in patients with acute lymphoblastic leukemia (ALL).
这项随机对照试验研究了在造血干细胞移植（HSCT）治疗期间给予帕利夫明作为剂量，对急性淋巴细胞白血病儿科患者进行一级预防以减少口腔黏膜炎（OM）的疗效。帕利夫明组患者被随机分配在自体HSCT输注前3天以及输注后0、+1和+2天静脉注射单剂量60μg/kg的帕利夫明。对照组患者仅接受安慰剂治疗。与OM相关的评估采用世界卫生组织口腔毒性量表和患者报告的结果。与对照组相比，帕利夫明组3级和4级OM的发生率有统计学意义的降低。帕利夫明组OM的严重程度也有所降低（相对于对照组的2.33级为1.65级）。帕利夫明可以预防急性淋巴细胞白血病（ALL）患者严重OM的复发并改善其生活质量。
