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[Lancet最新论文]:ANSWER试验显示,长期使用白蛋白改善失代偿肝硬化患者预后
2018年07月10日 时讯速递, 进展交流 暂无评论

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

Paolo Caraceni, Oliviero Riggio, Paolo Angeli, et al

Lancet 2018; 391: 2417-2429

Summary

Background 背景

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.

长期应用人白蛋白(HA)对失代偿肝硬化患者的疗效尚缺乏证据。ANSWER研究旨在探讨上述问题。

Methods 方法

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.

我们在意大利33家医院进行了一项研究者发起的多中心随机、平行、开放、实效研究。我们入选了接受抗醛固酮药物(≥200 mg/d) 及速尿 (≥25 mg/d) 治疗的合并腹水的肝硬化患者,并将其随机分为标准治疗组(SMT)或SMT加HA(40 g,每周2次共2周,然后每周40 g)至18个月。主要预后终点为意向治疗和符合方案人群的18个月病死率,根据事件差异及生存时间进行评估。这项研究分别在EudraCT(注册号2008–000625–19)和 ClinicalTrials.gov注册(注册号 NCT01288794)。

Findings 结果

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.

从2011年4月2日至2015年5月27日,共有440名患者接受随机分组,431名患者最终纳入修订后意向治疗分析。SMT+HA组218名患者中38名,及SMT组213名患者中46名死亡。SMT+HA组患者18个月生存率显著高于SMT组(Kaplan-Meier预测 77% vs 66%; p=0·028),病死率风险比降低 38% (0·62 [95% CI 0·40–0·95])。SMT组中46名 (22%) 患者及SMT+HA组49名 (22%) 患者发生3-4级非肝脏相关不良事件。

Interpretation 结论

In this trial, long-term HA administration prolongs overall survival and might act as a disease modifying treatment in patients with decompensated cirrhosis.

在这项研究中,长期使用HA延长失代偿肝硬化患者的总体生存时间,可能成为改变疾病的治疗措施。

Funding 资助

Italian Medicine Agency.

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