Recombinant factor VIIa for upper gastrointestinal bleeding in patients with cirrhosis: a randomized, double-blind trial.

摘要: Background & Aims: Upper gastrointestinal bleeding (UGIB) is a severe and frequent complication of cirrhosis. Recombinant coagulation factor VIIa (rFVIIa) has been shown to correct the prolonged prothrombin time in patients with cirrhosis UGIB. This trial aimed determine efficacy safety rFVIIa cirrhotic variceal nonvariceal Methods: A total 245 (Child-Pugh Results: Baseline characteristics were similar between placebo groups. showed no advantage over standard treatment whole population. Exploratory analyses, however, that significantly decreased number failures on composite end point ( P = 0.03) 24-hour control 0.01) subgroup Child-Pugh B C bleeders. There significant differences groups mortality (5- or 42-day) incidence adverse events including thromboembolic events. Conclusions: Although overall effect was observed, exploratory analyses indicated administration proportion who failed bleeding. Dosing appeared safe. Further studies are needed verify these findings.