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己酮可可碱预防异基因骨髓移植患者方案相关毒性的随机对照试验

A randomized controlled trial of pentoxifylline for the prevention of regimen-related toxicities in patients undergoing allogeneic marrow transplantation.

作者信息

Clift R A, Bianco J A, Appelbaum F R, Buckner C D, Singer J W, Bakke L, Bensinger W I, Bowden R A, McDonald G B, Schubert M

机构信息

Fred Hutchinson Cancer Research Center, Seattle, WA 98104-2092.

出版信息

Blood. 1993 Oct 1;82(7):2025-30.

PMID:8400255
Abstract

This study evaluated the effect of pentoxifylline (PTX) on the incidence of regimen-related toxicity in patients receiving allogeneic marrow transplants from related donors. All patients received a regimen of methotrexate and cyclosporine as prophylaxis against acute graft-versus-host disease (GVHD). Patients were randomized to receive PTX or a placebo for 70 days and the outcome was examined in a blinded fashion. Forty-four patients were evaluate in each study arm. PTX had no significant effect on engraftment, the incidence of GVHD, venocclusive disease of the liver, infection, the need for oxygen, posttransplant survival, or the duration of hospitalization. Patients receiving PTX were significantly more likely to develop major elevations of serum creatinine levels. PTX was poorly tolerated and induced significantly more vomiting than the placebo. PTX as administered in this randomized study was associated with significant toxicity and offered no benefit in reducing transplant-related morbidity or mortality.

摘要

本研究评估了己酮可可碱(PTX)对接受相关供体异基因骨髓移植患者的方案相关毒性发生率的影响。所有患者均接受甲氨蝶呤和环孢素方案以预防急性移植物抗宿主病(GVHD)。患者被随机分配接受PTX或安慰剂治疗70天,并以盲法检查结果。每个研究组评估了44例患者。PTX对植入、GVHD发生率、肝静脉闭塞病、感染、吸氧需求、移植后生存率或住院时间均无显著影响。接受PTX的患者血清肌酐水平显著升高的可能性更大。PTX耐受性差,与安慰剂相比,引起的呕吐明显更多。在这项随机研究中给予的PTX具有显著毒性,在降低移植相关发病率或死亡率方面没有益处。

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