McMullin Neil R, Kauvar David S, Currier Heather M, Baskin Toney W, Pusateri Anthony E, Holcomb John B
United States Army Institute of Surgical Research, Fort Sam Houston, TX 78234, USA.
Curr Surg. 2006 Jul-Aug;63(4):246-51. doi: 10.1016/j.cursur.2006.03.007.
In bleeding patients who are coagulopathic, the clinical response to administration of recombinant factor VIIa (rFVIIa) relates to the changes in prothrombin time (PT).
Retrospective review of all surgical and trauma patients who were coagulopathic and received factor VIIa at the authors' institution over the past 27 months.
Academic tertiary referral facility and level I trauma center.
Eighteen patients met inclusion criteria, 10 trauma and 8 surgical. Mean age 50 years (range, 17-84).
Overall mortality was 39%. All but 1 patient (17/18) had resolution of coagulopathic bleeding with rFVIIa, and all clinical responders (n = 17) (defined as clinical cessation of bleeding within 24 hours determined by either attending surgeon or chief resident progress note) had a decrease in PT to normal range. In contrast, the single clinical nonresponder had an insignificant PT decrease (19 to 18 seconds). Prothrombin time decreased from 20 +/- 4 seconds to 12 +/- 2 seconds, p < 0.05 (n = 17). International Normalized Ratio (INR) decreased from 1.59 to 0.86, p < 0.05 (n = 17). Fibrinogen before administration was 299.73 (range, 105-564) (n = 15). pH before administration was 7.25 (+/-0.18) (n = 10). Patient temperature was 98.64 (+/-2.06). Effect in partial thromboplastin time (PTT) was inconsistent (50 +/- 49 seconds to 34 +/- 6 seconds, p > 0.05). Transfusion requirements for red blood cells (14 to 3 units) and plasma (12 to 3 units) were significantly reduced after rFVIIa. There were no significant differences in percentage PT decrease between dose > or =100 mcg/kg vs <100 mcg/kg, surgical vs trauma patients, survivors vs nonsurvivors, and those with pretreatment platelet count > or =100 K vs <100 K.
The administration of rFVIIa caused a decrease in the PT in nearly all patients. There were an insufficient number of patients to support the use of PT as a clinical predictor of response; however, the data are suggestive of such utility. If the PT does not correct, then it is likely that there is a deficiency of other factors of the coagulation cascade.
在凝血功能障碍的出血患者中，重组凝血因子VIIa（rFVIIa）给药后的临床反应与凝血酶原时间（PT）的变化相关。
回顾性分析过去27个月内在作者所在机构接受凝血因子VIIa治疗的所有凝血功能障碍的外科和创伤患者。
学术性三级转诊机构和I级创伤中心。
18例患者符合纳入标准，其中10例为创伤患者，8例为外科手术患者。平均年龄50岁（范围17 - 84岁）。
总死亡率为39%。除1例患者外（17/18），所有患者的凝血功能障碍性出血均通过rFVIIa得到缓解，所有临床有反应者（n = 17）（定义为经主刀医生或住院总医师病程记录确定在24小时内临床出血停止）PT均降至正常范围。相比之下，唯一的临床无反应者PT下降不明显（从19秒降至18秒）。凝血酶原时间从20±4秒降至12±2秒，p < 0.05（n = 17）。国际标准化比值（INR）从1.59降至0.86，p < 0.05（n = 17）。给药前纤维蛋白原为299.73（范围105 - 564）（n = 15）。给药前pH值为7.25（±0.18）（n = 10）。患者体温为98.64（±2.06）。对部分凝血活酶时间（PTT）的影响不一致（从50±49秒降至34±6秒，p > 0.05）。rFVIIa治疗后，红细胞（从14单位降至3单位）和血浆（从12单位降至3单位）的输血需求量显著减少。剂量≥100 mcg/kg与<100 mcg/kg、外科手术患者与创伤患者、存活者与非存活者以及治疗前血小板计数≥100 K与<100 K的患者之间，PT下降百分比无显著差异。
几乎所有患者使用rFVIIa后PT均下降。支持将PT作为反应的临床预测指标的患者数量不足；然而，数据提示有这种可能性。如果PT未得到纠正，那么很可能存在凝血级联反应中其他因子的缺乏。
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