作者: Anne Wikkelsø , Jens Lunde , Mathias Johansen , Jakob Stensballe , Jørn Wetterslev
DOI: 10.1002/14651858.CD008864.PUB2
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摘要: Background Hypofibrinogenaemia is associated with increased morbidity and mortality, but the optimal treatment level, use of preemptive preferred source fibrinogen remain disputed. Fibrinogen concentrate increasingly used recommended for bleeding acquired haemostatic deficiencies in several countries, evidence lacking regarding indications, dosing, efficacy safety. Objectives We assessed benefits harms compared placebo or usual patients. Search methods We searched following electronic databases: Cochrane Central Register Controlled Trials (CENTRAL) (The Library 2013, Issue 8); MEDLINE (1950 to 9 August 2013); EMBASE (1980 International Web Science (1964 CINAHL LILACS (1982 Chinese Biomedical Literature Database (up 10 November 2011), together databases ongoing trials. We contacted trial authors, authors previous reviews manufacturers field. Selection criteria We included all randomized controlled trials (RCTs), irrespective blinding language, that placebo/other no patients, excluding neonates patients hereditary disorders. Data collection analysis Three review independently abstracted data; we resolved any disagreements by discussion. Our primary outcome measure was all-cause mortality. performed subgroup sensitivity analyses assess effects adults children terms various clinical physiological outcomes. presented pooled estimates intervention on dichotomous outcomes as risk ratios (RRs) continuous mean differences, 95% confidence intervals (CIs). bias through assessment methodological components random error sequential analysis. Main results We six RCTs a total 248 participants; none were determined have overall low bias. found 12 trials, from which unable retrieve data. Only two provided data one zero event study; thus meta-analysis showed statistically significant effect mortality (2.6% vs 9.5%, RR 0.28, CI 0.03 2.33). blood transfusion suggest beneficial reducing incidence allogenic transfusions (RR 0.47, 0.31 0.72) show other predefined outcomes, including adverse events such thrombotic episodes. Authors' conclusions In available elective surgery, appears reduce requirements, are quality high underpowered detect benefit harm. Furthermore, lacking, heterogeneity acute severe non-elective surgical setting remains unexplored. Currently, weak supports tested here primarily cardiac surgery. More research urgently needed.