Recombinant factor VIIa for the prevention and treatment of bleeding in patients without haemophilia

摘要: Background Recombinant factor VIIa (rFVIIa) is licensed for use in patients with haemophilia and inhibitory allo-antibodies prophylaxis treatment of congenital VII deficiency. It also used off-license indications to prevent bleeding operations where blood loss likely be high, and/or stop that proving difficult control by other means. This the third version 2007 Cochrane review on recombinant prevention without haemophilia, has been updated incorporate recent trial data. Objectives To assess effectiveness rFVIIa when therapeutically active or prophylactically (excessive) haemophilia. Search methods We searched Central Register Controlled Trials (CENTRAL), MEDLINE, EMBASE medical databases up 23 March 2011. Selection criteria Randomised controlled trials (RCTs) comparing placebo, one dose another, any patient population (except haemophilia). Outcomes were mortality, bleeding, red cell transfusion requirements, number transfused thromboembolic adverse events. Data collection analysis Two authors independently assessed potentially relevant studies inclusion, extracted data examined risk bias. We considered prophylactic therapeutic separately. Main results Twenty-nine RCTs included: 28 placebo-controlled, double-blind compared different doses rFVIIa. In 'Risk bias' assessment, most found have some threats validity although less prone bias than RCTs. Sixteen involving 1361 participants rFVIIa; 729 received There was no evidence mortality benefit (risk ratio (RR) 1.04; 95% confidence interval (CI) 0.55 1.97). decreased (mean difference (MD) -297 mL; CI -416 -178) requirements (MD -261 -367 -154) treatment; however, these values overestimated due inability from (four outcome three requirements) showing placebo. a trend favour (RR 0.85; 0.72 1.01). However, there against respect events 1.35; 0.82 2.25). Thirteen 2929 1878 outcomes observed advantage disadvantage over placebo could not chance alone. reducing 0.91; 0.78 1.06). increased 1.14; 0.89 1.47). When all pooled together examine events, significant increase total arterial 1.45; 1.02 2.05). Authors' conclusions The as more general haemostatic drug, either therapeutically, remains unproven. The results indicate receiving outside its current should restricted clinical trials.