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一项关于在血液系统恶性肿瘤自体干细胞移植中使用或不使用谷氨酰胺进行预防性肠外营养支持的随机双盲对照研究——三年随访

A randomized, double blind comparative study of prophylactic parenteral nutritional support with or without glutamine in autologous stem cell transplantation for hematological malignancies -- three years' follow-up.

作者信息

Sykorova A, Horacek J, Zak P, Kmonicek M, Bukac J, Maly J

机构信息

2nd Department of Internal Medicine, Charles University, Faculty of Medicine and University Hospital, 500 05 Hradec Kralove, Czech Republic.

出版信息

Neoplasma. 2005;52(6):476-82.

PMID:16284692
Abstract

Forty-four adult autologous transplant patients with hematological malignancies were randomized to receive either prophylactic parenteral nutrition PN (P group), or PN given ad hoc (C group). In each group, they were further randomized to receive standard PN (B group), or PN with 0.5 g glutamine/kg as L-Ala-L-Gln (A group). The overall survival (OS), disease-free survival (DFS) and event-free survival (EFS) in groups C vs. P and A vs. B were compared during follow-up with median 38 months. The final outcome rates in C/P/A/B groups, respectively (OS 65/81/63/85%, EFS 45/53/33/65% and DFS 56/50/35/77%), were not significantly different, apart from A < B in DFS rate (p=0.03, Fisher's exact test). Also in survival analysis (logrank test), no significant difference between groups C and P was found but generally worse parameters were observed for A vs. B group: for DFS (p=0.04) and EFS (p=0.01) the difference was significant, and for OS (p=0.09) it was borderline. In the three years' follow-up, no clinically useful benefit of prophylactic PN in autologous transplant patients was proven. Also, glutamine supplementation was not helpful, and was even connected with apparently worse long-term outcome.

摘要

44例患有血液系统恶性肿瘤的成年自体移植患者被随机分为两组,一组接受预防性肠外营养(PN)(P组),另一组按需给予PN(C组)。在每组中,患者又被进一步随机分为接受标准PN(B组)或接受含0.5 g谷氨酰胺/ kg的L-丙氨酰-L-谷氨酰胺的PN(A组)。在中位随访38个月期间,比较了C组与P组以及A组与B组的总生存期(OS)、无病生存期(DFS)和无事件生存期(EFS)。C/P/A/B组的最终结局率分别为(OS 65/81/63/85%,EFS 45/53/33/65%,DFS 56/50/35/77%),除DFS率A组低于B组外(p = 0.03,Fisher精确检验),差异均无统计学意义。在生存分析(对数秩检验)中,C组和P组之间未发现显著差异,但A组与B组相比总体参数较差:DFS(p = 0.04)和EFS(p = 0.01)差异有统计学意义,OS(p = 0.09)差异接近显著。在三年的随访中,未证明预防性PN对自体移植患者有临床有益作用。此外,补充谷氨酰胺也无帮助,甚至与明显较差的长期结局相关。

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