在非补偿性肝硬化 (ANSWER) 中长期使用白蛋白:一个开放的随机试验
Paolo Caraceni1, Oliviero Riggio2, Paolo Angeli3
1Department of Medical and Surgical Sciences, and Center for Applied Biomedical Research, University of Bologna, Bologna, Italy.
Lancet (London, England)
|June 5, 2018
概括
在非补偿性肝硬化患者中,长期使用人体白蛋白 (HA) 显著改善了生存率. 这种治疗可能会改变疾病的进展,为肝硬化患者提供新的治疗途径.
科学领域:
- 肝病学
- 临床试验
- 内部医学
背景情况:
- 关于人类白蛋白 (HA) 治疗脱补偿性肝硬化症的长期疗效的证据有限.
- 这项ANSWER研究旨在解决这一知识差距.
研究的目的:
- 评估长期使用人体白蛋白治疗的肝硬化患者的疗效.
- 评估HA对整体存活率和疾病改变的影响.
主要方法:
- 一个多中心的,随机的,开放的实用性试验,涉及440名肝硬化和无并发性瘤患者.
- 患者接受了标准医疗 (SMT) 或SMT加人体白蛋白 (HA) 治疗长达18个月.
- 主要终点是18个月死亡率.
主要成果:
- 与SMT组相比,SMT加HA组的18个月生存率显著高 (77%),死亡风险比率降低了38% (p=0. 028).
- 两组之间没有观察到与肝脏无关的3-4级不良事件的显著差异.
结论:
- 在非补偿性肝硬化患者中,长期服用人体白蛋白可延长整体存活期.
- 在这种患者群体中,HA可能起到改变疾病的作用.
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