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.

中文翻译：

---

造血干细胞移植：出血并发症的影响。

急性移植物抗宿主病（GVHD）是同种异体造血干细胞移植（HSCT）的最重要并发症，增加了对出血的易感性和早期死亡的风险。我们评估了807名同种异体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患者经历了出血，而23％的0-1级患者经历了出血。此外，接受非HLA相同移植的患者中有45％发生了出血，而接受来自HLA相同供体的移植患者中只有23％发生了出血。这可以用非HLA相同的移植患者中严重GVHD发生率更高来解释。我们的研究结果还表明，出血并发症（尤其是胃肠道出血）明显增加了患者的死亡率。正在进行的一项多中心，随机，双盲试验正在研究重组因子VIIa（rFVIIa； NovoSeven）在治疗HSCT相关性出血中的功效和安全性。该试验将研究三种剂量水平的rFVIIa降低或什至完全消除出血的发生率和严重程度的能力。预计将招募100名患者，并希望在2003年底获得初步数据。NovoSeven）治疗HSCT相关性出血。该试验将研究三种剂量水平的rFVIIa降低或什至完全消除出血的发生率和严重程度的能力。预计将招募100名患者，并希望在2003年底获得初步数据。NovoSeven）治疗HSCT相关性出血。该试验将研究三种剂量水平的rFVIIa降低或什至完全消除出血的发生率和严重程度的能力。预计将招募100名患者，并希望在2003年底获得初步数据。