Long-term albumin administration in decompensated cirrhosis (ANSWER): an open-label randomised trial

被引：360

作者：

Caraceni, Paolo ^{[1
,2
]}

Riggio, Oliviero ^{[3
]}

Angeli, Paolo ^{[4
]}

Alessandria, Carlo ^{[5
]}

Neri, Sergio ^{[6
]}

Foschi, Francesco G. ^{[7
]}

Levantesi, Fabio ^{[8
]}

Airoldi, Aldo ^{[9
]}

Boccia, Sergio ^{[10
]}

Svegliati-Baroni, Gianluca ^{[11
]}

Fagiuoli, Stefano ^{[12
]}

Romanelli, Roberto G. ^{[13
]}

Cozzolongo, Raffaele ^{[14
]}

Di Marco, Vito ^{[15
]}

Sangiovanni, Vincenzo ^{[16
]}

Morisco, Filomena ^{[17
]}

Toniutto, Pierluigi ^{[18
]}

Tortora, Annalisa ^{[19
]}

De Marco, Rosanna ^{[20
]}

Angelico, Mario ^{[21
]}

Cacciola, Irene ^{[22
]}

Elia, Gianfranco ^{[23
]}

Federico, Alessandro ^{[24
]}

Massironi, Sara ^{[25
,26
]}

Guarisco, Riccardo ^{[27
]}

Galioto, Alessandra ^{[28
]}

Ballardini, Giorgio ^{[29
]}

Rendina, Maria ^{[30
]}

Nardelli, Silvia ^{[3
]}

Piano, Salvatore ^{[4
]}

Elia, Chiara ^{[5
]}

Prestianni, Loredana ^{[6
]}

Cappa, Federica Mirici ^{[7
]}

Cesarini, Lucia ^{[9
]}

Simone, Loredana ^{[10
]}

Pasquale, Chiara ^{[3
]}

Cavallin, Marta ^{[4
]}

Andrealli, Alida ^{[5
]}

Fidone, Federica ^{[6
]}

Ruggeri, Matteo ^{[31
]}

Roncadori, Andrea ^{[32
]}

Baldassarre, Maurizio ^{[1
,2
]}

Tufoni, Manuel ^{[1
,2
]}

Zaccherini, Giacomo ^{[1
,2
]}

Bernardi, Mauro ^{[1
,2
]}

机构：

[1] Univ Bologna, Dept Med & Surg Sci, Bologna, Italy

[2] Univ Bologna, Ctr Appl Biomed Res, Bologna, Italy

[3] Sapienza Univ Rome, Dept Clin Med, Rome, Italy

[4] Univ Padua, Dept Med, Unit Internal Med & Hepatol, Padua, Italy

[5] Univ Turin, Div Gastroenterol & Hepatol, Citta Salute & Sci Hosp, Turin, Italy

[6] Univ Catania, Dept Clin & Expt Med, Catania, Italy

[7] Hosp Faenza, Internal Med, Azienda Unita Sanit Locale Romagna, Faenza, Italy

[8] Hosp Bentivoglio, AUSL Bologna, Internal Med, Bologna, Italy

[9] Osped Niguarda Ca Granda, Dept Gastroenterol & Hepatol, Liver Unit, Milan, Italy

[10] Univ Hosp, Gastroenterol Unit, Ferrara, Italy

[11] Polytech Univ Marche, Dept Gastroenterol, Ancona, Italy

[12] Papa Giovanni XXIII Hosp, Gastroenterol & Transplant Hepatol, Bergamo, Italy

[13] Univ Florence, Dept Expt & Clin Med, Florence, Italy

[14] Natl Inst Gastroenterol S De Bellis, Div Gastroenterol, Bari, Italy

[15] Univ Palermo, Biomed Dept Internal & Specialist Med, Unit Gastroenterol & Hepatol, Palermo, Italy

[16] Cotugno Hosp Naples, Azienda Osped Rilievo Nazl Colli, Naples, Italy

[17] Federico II Univ Naples, Dept Clin Med & Surg, Gastroenterol Unit, Naples, Italy

[18] Univ Udine, Dept Med Area, Internal Med, Udine, Italy

[19] Catholic Univ, Gemelli Fdn, Gastroenterol, Rome, Italy

[20] Hosp Cosenza, Gastroenterol Unit, Cosenza, Italy

[21] Tor Vergata Univ, Liver Unit, Rome, Italy

[22] Univ Hosp Messina, Div Clin & Mol Hepatol, Messina, Italy

[23] Univ Hosp Parma, Infect Dis & Hepatol, Parma, Italy

[24] Univ Campania Luigi Vanvitelli, Dept Clin & Expt Internal Med, Naples, Italy

[25] Fdn Ist Ricovero, Gastroenterol & Endoscopy Unit, Milan, Italy

[26] Cura Carattere Sci Ca Granda Osped Maggiore Polic, Milan, Italy

[27] S Sebastiano Gen Hosp, Internal Med, Rome, Italy

[28] Hosp Dolo, Internal Med, Azienda Unita Locale Sociosanit Serenissima, Venice, Italy

[29] Hosp Rimini, AUSL Romagna, Rimini, Italy

[30] Univ Bari, Sect Gastroenterol, Dept Emergency & Organ Transplantat, Bari, Italy

[31] Catholic Univ, Grad Sch Hlth Econ & Management, Rome, Italy

[32] Cineca Interuniv Consortium, Bologna, Italy

来源：

LANCET | 2018年 / 391卷 / 10138期

关键词：

PERIPHERAL ARTERIAL VASODILATION; PLASMA EXPANDERS; NATURAL-HISTORY; LIVER-DISEASE; ASCITES; INFECTIONS; MANAGEMENT; SURVIVAL; IMPROVES; FAILURE;

D O I：

10.1016/S0140-6736(18)30840-7

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Background Evidence is scarce on the efficacy of long-term human albumin (HA) administration in patients with decompensated cirrhosis. The human Albumin for the treatmeNt of aScites in patients With hEpatic ciRrhosis (ANSWER) study was designed to clarify this issue. Methods We did an investigator-initiated multicentre randomised, parallel, open-label, pragmatic trial in 33 academic and non-academic Italian hospitals. We randomly assigned patients with cirrhosis and uncomplicated ascites who were treated with anti-aldosteronic drugs (>= 200 mg/day) and furosemide (>= 25 mg/day) to receive either standard medical treatment (SMT) or SMT plus HA (40 g twice weekly for 2 weeks, and then 40 g weekly) for up to 18 months. The primary endpoint was 18-month mortality, evaluated as difference of events and analysis of survival time in patients included in the modified intention-to-treat and per-protocol populations. This study is registered with EudraCT, number 2008-000625-19, and ClinicalTrials. gov, number NCT01288794. Findings From April 2, 2011, to May 27, 2015, 440 patients were randomly assigned and 431 were included in the modified intention-to-treat analysis. 38 of 218 patients died in the SMT plus HA group and 46 of 213 in the SMT group. Overall 18-month survival was significantly higher in the SMT plus HA than in the SMT group (Kaplan-Meier estimates 77% vs 66%; p=0.028), resulting in a 38% reduction in the mortality hazard ratio (0.62 [95% CI 0.40-0.95]). 46 (22%) patients in the SMT group and 49 (22%) in the SMT plus HA group had grade 3-4 non-liver related adverse events. Interpretation In this trial, long-term HA administration prolongs overall survival and might act as a disease modifying treatment in patients with decompensated cirrhosis. (C) 2018 Elsevier Ltd. All rights reserved.

引用

页码：2417 / 2429

页数：13

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