Department of Pharmacy Services, Medical University of South Carolina, Charleston, SC, USA.
Ann Pharmacother. 2011 Nov;45(11):1433-8. doi: 10.1345/aph.1Q207. Epub 2011 Oct 18.
To evaluate the use of recombinant activated factor VII (rFVIIa) in patients with liver failure undergoing invasive procedures.
An OVID/MEDLINE and PubMed search (1997-June 2011) was performed to identify literature on the use of rFVIIa to reduce bleeding risk in patients with liver failure undergoing invasive procedures.
English-language data evaluating the efficacy of rFVIIa to reverse coagulopathies prior to invasive procedures in patients with liver disease were included.
Following administration of rFVIIa, prothrombin time (PT) and international normalized ratio (INR) response is within 30 minutes. Doses ranging from 20 to 120 μg/kg have been studied, with a reduction in PT seen in a dose-dependent manner. One study in patients with no bleeding administered 5, 20, and 80 μg/kg sequentially during a 24-day period. All doses provided reversal of prolonged PT within 10 minutes, and the duration was dose-dependent. In a study of 15 patients with fulminant liver failure, requiring intracranial pressure monitor placement, a rFVIIa dose of 40 μg/kg was compared to fresh frozen plasma. In patients who received rFVIIa, the PT and INR normalized, compared to none of the patients in the fresh frozen plasma group.
Retrospective and prospective data demonstrate that rFVIIa effectively reverses elevated PT and INR, reducing the risk of bleeding and safely facilitating invasive procedures. Based on available data, a dose of 20-40 μg/kg 30 minutes prior to an invasive procedure should be considered in patients with acute or chronic liver failure at risk for bleeding complications. A major limitation of rFVIIa use is the high cost of therapy. A prospective, randomized trial could help determine the appropriate dose of rFVIIa, timing of dose in relationship to procedure, and usefulness of subsequent doses.
评估在接受有创性操作的肝衰竭患者中使用重组活化因子 VII（rFVIIa）的效果。
通过 OVID/MEDLINE 和 PubMed 检索（1997 年-2011 年 6 月），查找评估 rFVIIa 降低肝衰竭患者接受有创性操作时出血风险效果的文献。
纳入了评估 rFVIIa 逆转肝疾病患者有创性操作前凝血障碍的有效性的英语文献。
rFVIIa 给药后，凝血酶原时间（PT）和国际标准化比值（INR）在 30 分钟内得到纠正。研究了 20-120μg/kg 剂量，发现剂量依赖性降低 PT。在一项无出血患者的研究中，在 24 天期间依次给予 5、20 和 80μg/kg，所有剂量均在 10 分钟内纠正了延长的 PT，且与剂量呈依赖性。在一项需要颅内压监测置入的暴发性肝衰竭患者的研究中，比较了 rFVIIa 剂量 40μg/kg 与新鲜冷冻血浆。接受 rFVIIa 的患者的 PT 和 INR 恢复正常，而新鲜冷冻血浆组无一例患者如此。
回顾性和前瞻性数据表明，rFVIIa 可有效纠正升高的 PT 和 INR，降低出血风险并安全地促进有创性操作。基于现有数据，在有出血并发症风险的急性或慢性肝衰竭患者中，应考虑在有创性操作前 30 分钟给予 20-40μg/kg 的 rFVIIa。rFVIIa 治疗的一个主要局限性是治疗费用高。前瞻性、随机试验可以帮助确定 rFVIIa 的适当剂量、与操作相关的剂量时间以及后续剂量的用途。
