Ventura-Cots Meritxell, Simón-Talero Macarena, Poca Maria, Ariza Xavier, Masnou Helena, Sanchez Jordi, Llop Elba, Cañete Núria, Martín-Llahí Marta, Amador Alberto, Martínez Javier, Clemente-Sanchez Ana, Puente Angela, Torrens Maria, Alvarado-Tapias Edilmar, Napoleone Laura, Miquel-Planas Mireia, Ardèvol Alba, Casas Rodrigo Meritxell, Calleja Jose Luís, Solé Cristina, Soriano German, Genescà Joan
Liver Unit, Department of Internal Medicine, Hospital Universitari Vall d'Hebron, Vall d'Hebron Institut de Recerca (VHIR), Vall d'Hebron Barcelona Hospital Campus, Universitat Autònoma de Barcelona, 08035 Barcelona, Spain.
Centro de Investigación Biomédica en Red, Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, 28029 Madrid, Spain.
J Clin Med. 2021 Oct 23;10(21):4885. doi: 10.3390/jcm10214885.
No therapies have been proven to increase survival after a hepatic encephalopathy (HE) episode. We hypothesize that two doses of albumin could improve 90-day survival rates after a HE episode.
(1) A randomized double-blind, placebo-controlled trial (BETA) was conducted in 12 hospitals. The effect of albumin (1.5 g/kg at baseline and 1 g/kg on day 3) on 90-day survival rates after a HE episode grade II or higher was evaluated. (2) A meta-analysis of individual patient's data for survival including two clinical trials (BETA and ALFAE) was performed.
In total, 82 patients were included. Albumin failed to increase the 90-day transplant-free survival (91.9% vs. 80.5%, = 0.3). A competing risk analysis was performed, observing a 90-day cumulative incidence of death of 9% in the albumin group vs. 20% in the placebo ( = 0.1). The meta-analysis showed a benefit in the albumin group, with a lower rate of clinical events (death or liver transplant) than patients in the placebo (HR, 0.44; 95% CI, 0.21-0.82), when analyzed by a competing risk analysis (90-days mortality rate of 11% in the albumin group vs. 30% in the placebo, = 0.02).
Repeated doses of albumin might be beneficial for patient's survival as an add-on therapy after an HE episode, but an adequately powered trial is needed.
尚无疗法被证实可提高肝性脑病（HE）发作后的生存率。我们假设两剂白蛋白可提高HE发作后的90天生存率。
（1）在12家医院进行了一项随机双盲、安慰剂对照试验（BETA）。评估了白蛋白（基线时1.5 g/kg，第3天1 g/kg）对II级或更高等级HE发作后90天生存率的影响。（2）对包括两项临床试验（BETA和ALFAE）在内的个体患者生存数据进行了荟萃分析。
总共纳入了82例患者。白蛋白未能提高90天无移植生存率（91.9%对80.5%，P = 0.3）。进行了竞争风险分析，观察到白蛋白组90天累积死亡率为9%，而安慰剂组为20%（P = 0.1）。荟萃分析显示白蛋白组有获益，通过竞争风险分析，白蛋白组临床事件（死亡或肝移植）发生率低于安慰剂组患者（HR，0.44；95%CI，0.21 - 0.82）（白蛋白组90天死亡率为11%，安慰剂组为30%，P = 0.02）。
重复剂量的白蛋白作为HE发作后的附加治疗可能对患者生存有益，但需要进行有足够效力的试验。
