Biss T T, Hanley J P
Department of Haematology, Newcastle upon Tyne Hospitals NHS Trust, Newcastle upon Tyne, UK.
Vox Sang. 2006 Jan;90(1):45-52. doi: 10.1111/j.1423-0410.2005.00711.x.
Recombinant activated factor VII (rFVIIa/NovoSeven) has been advocated in the treatment of life-threatening haemorrhage, but appropriate clinical indications remain uncertain. The aim of this study was to detect factors predictive of outcome and to incorporate them into a prognostically significant scoring system.
Thirty-six patients received rFVIIa for uncontrolled surgical, traumatic or obstetric bleeding in the Northern Region of the UK over a 45-month period. Clinical, laboratory and outcome data were examined. Characteristics of survivor and non-survivor groups were compared. A prognostic scoring system was evaluated retrospectively according to the presence of coagulopathy, renal impairment, hypothermia, greater than 10 units of red cell transfusion, advanced age and obstetric indication, with patients allocated to low, intermediate and high-risk groups.
Clinical response occurred in 26 patients (72%) with a reduction in prothrombin time and blood product requirements. Death occurred in 19 (53%). Four patients (11%) suffered thrombotic events. Survivors were younger than non-survivors and less likely to have coagulopathy, renal impairment or hypothermia at the time of administration. Survivors were more likely to have had an initial clinical response in terms of an immediate reduction in haemorrhage. Non-survivors were transfused a greater number of red cell units prior to administration. Survival varied according to prognostic score; low-risk patients had a survival rate of 85%, intermediate-risk patients had a survival rate of 50% and high-risk patients had a survival rate of 18%.
FVIIa has a role in the cessation of haemorrhage, but may not improve survival. Use of a clinical scoring system may help to predict outcome.
重组活化凝血因子VII（rFVIIa/诺其）已被推荐用于治疗危及生命的出血，但合适的临床适应症仍不明确。本研究的目的是检测预测预后的因素，并将其纳入具有预后意义的评分系统。
在英国北部地区，36例患者在45个月期间接受了rFVIIa治疗，用于控制手术、创伤或产科出血。对临床、实验室和预后数据进行了检查。比较了存活组和非存活组的特征。根据是否存在凝血病、肾功能损害、体温过低、输注红细胞超过10单位、高龄和产科适应症，对一个预后评分系统进行回顾性评估，将患者分为低、中、高风险组。
26例患者（72%）出现临床反应，凝血酶原时间缩短，血液制品需求减少。19例（53%）死亡。4例患者（11%）发生血栓事件。存活者比非存活者年轻，给药时发生凝血病、肾功能损害或体温过低的可能性较小。就出血立即减少而言，存活者更有可能有初始临床反应。非存活者在给药前输注的红细胞单位数量更多。生存率根据预后评分而异；低风险患者的生存率为85%，中风险患者的生存率为50%，高风险患者的生存率为18%。
FVIIa在止血方面有作用，但可能无法提高生存率。使用临床评分系统可能有助于预测预后。
