Bacigalupo Andrea
Department of Haematology, Bone Marrow Transplant Unit, Ospedale, San Martino, Genova, Italy.
Blood Rev. 2003 Sep;17 Suppl 1:S6-10. doi: 10.1016/s0268-960x(03)90001-4.
Acute graft-versus-host disease (GVHD) is the most important complication of allogeneic haemopoietic stem cell transplantation (HSCT), increasing susceptibility to haemorrhage and risk of early mortality. We evaluated 807 allogeneic HSCT patients to assess both the association between bleeding and GVHD, and the influence of haemorrhagic complications on clinical outcome. Up to 55% of patients with grade III-IV GVHD experienced bleeding, compared with 23% of patients with grades 0-l. Furthermore, 45% of patients receiving non-HLA-identical transplants suffered haemorrhage, whereas only 23% of patients receiving transplants from HLA-identical donors experienced bleeding. This can be explained by the higher incidence of severe GVHD among recipients of non-HLA-identical transplants. Our findings also demonstrated that haemorrhagic complications--particularly bleeding from the GI tract--markedly increase patient mortality. An ongoing, multi-centre, randomised, double-blind trial is currently investigating the efficacy and safety of recombinant factor VIIa (rFVIIa; NovoSeven) in the treatment of HSCT-associated bleeding. The trial will examine the ability of three dose levels of rFVIIa to reduce--or even eliminate entirely--the incidence and severity of haemorrhage following such procedures. A total enrollment of 100 patients is anticipated, and preliminary data are expected at the end of 2003.
急性移植物抗宿主病（GVHD）是异基因造血干细胞移植（HSCT）最重要的并发症，会增加出血易感性和早期死亡风险。我们评估了807例异基因HSCT患者，以评估出血与GVHD之间的关联以及出血并发症对临床结局的影响。高达55%的III-IV级GVHD患者出现出血，而0-I级患者的这一比例为23%。此外，接受非HLA配型相合移植的患者中有45%发生出血，而接受HLA配型相合供者移植的患者中只有23%出现出血。这可以用非HLA配型相合移植受者中严重GVHD的发生率较高来解释。我们的研究结果还表明，出血并发症——尤其是胃肠道出血——会显著增加患者死亡率。一项正在进行的多中心、随机、双盲试验目前正在研究重组因子VIIa（rFVIIa；诺其）治疗HSCT相关出血的疗效和安全性。该试验将研究三个剂量水平的rFVIIa降低——甚至完全消除——此类手术后出血发生率和严重程度的能力。预计总共招募100名患者，初步数据将于2003年底得出。
