Bernstein D E, Jeffers L, Erhardtsen E, Reddy K R, Glazer S, Squiban P, Bech R, Hedner U, Schiff E R
Department of Hepatology, University of Miami School of Medicine, Florida, USA.
Gastroenterology. 1997 Dec;113(6):1930-7. doi: 10.1016/s0016-5085(97)70013-1.
BACKGROUND & AIMS: Cirrhotic patients with a prolonged prothrombin time (PT) are known to have low levels of factor VII. Because the current modalities to correct this problem are not ideal, recombinant factor VIIa (rFVIIa) may be useful in correcting the prolonged PT observed in the coagulopathy of cirrhosis. The aim of this study was to evaluate the effectiveness of rFVIIa in nonbleeding volunteer patients with the coagulopathy of cirrhosis.
A preliminary, single-center, dose-escalation trial was performed. Cirrhotic patients with a PT of > 2 seconds above the upper limit of the reference value received an intramuscular injection of vitamin K. Ten patients whose PT did not correct to within 2 seconds above the control of the upper limit of the reference value were given three successive dosages of rFVIIa (5, 20, and 80 micrograms/kg) during a 3-week period.
The mean PT transiently corrected to normal in all three dosage groups. No adverse effects were noted. There was no evidence of the induction of disseminated intravascular coagulation.
This preliminary trial shows rFVIIa to be effective in transiently reversing the prolonged PT in a select group of nonbleeding cirrhotic patients. These preliminary observations support conducting a large-scale efficacy trial.
已知凝血酶原时间（PT）延长的肝硬化患者因子VII水平较低。由于目前纠正该问题的方法并不理想，重组因子VIIa（rFVIIa）可能有助于纠正肝硬化凝血病中观察到的PT延长。本研究的目的是评估rFVIIa对肝硬化凝血病非出血志愿者患者的有效性。
进行了一项初步的单中心剂量递增试验。PT超过参考值上限2秒以上的肝硬化患者接受维生素K肌肉注射。10名PT未纠正至比参考值上限对照高2秒以内的患者在3周内连续接受三次rFVIIa剂量（5、20和80微克/千克）。
所有三个剂量组的平均PT均短暂纠正至正常。未观察到不良反应。没有证据表明诱发了弥散性血管内凝血。
这项初步试验表明，rFVIIa可有效短暂逆转一组特定的非出血性肝硬化患者延长的PT。这些初步观察结果支持进行大规模疗效试验。
