医学
临床终点
危险系数
肝移植
移植
内科学
随机对照试验
置信区间
人口
外科
胃肠病学
环境卫生
作者
Fin Stolze Larsen,Lars E. Schmidt,Christine Bernsmeier,Allan Rasmussen,Helena Isoniemi,Vishal C. Patel,Evangelos Triantafyllou,William Bernal,G. Auzinger,Debbie L. Shawcross,Martin Eefsen,Peter Nissen Bjerring,J Clemmesen,K Höckerstedt,Hans Jørgen Frederiksen,Bent Adel Hansen,Charalambos Antoniades,Julia Wendon
标识
DOI:10.1016/j.jhep.2015.08.018
摘要
Acute liver failure (ALF) often results in cardiovascular instability, renal failure, brain oedema and death either due to irreversible shock, cerebral herniation or development of multiple organ failure. High-volume plasma exchange (HVP), defined as exchange of 8-12 or 15% of ideal body weight with fresh frozen plasma in case series improves systemic, cerebral and splanchnic parameters.In this prospective, randomised, controlled, multicentre trial we randomly assigned 182 patients with ALF to receive either standard medical therapy (SMT; 90 patients) or SMT plus HVP for three days (92 patients). The baseline characteristics of the groups were similar. The primary endpoint was liver transplantation-free survival during hospital stay. Secondary-endpoints included survival after liver transplantation with or without HVP with intention-to-treat analysis. A proof-of-principle study evaluating the effect of HVP on the immune cell function was also undertaken.For the entire patient population, overall hospital survival was 58.7% for patients treated with HVP vs. 47.8% for the control group (hazard ratio (HR), with stratification for liver transplantation: 0.56; 95% confidence interval (CI), 0.36-0.86; p=0.0083). HVP prior to transplantation did not improve survival compared with patients who received SMT alone (CI 0.37 to 3.98; p=0.75). The incidence of severe adverse events was similar in the two groups. Systemic inflammatory response syndrome (SIRS) and sequential organ failure assessment (SOFA) scores fell in the treated group compared to control group, over the study period (p<0.001).Treatment with HVP improves outcome in patients with ALF by increasing liver transplant-free survival. This is attributable to attenuation of innate immune activation and amelioration of multi-organ dysfunction.
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