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Albumin Infusions in Hospitalized Patients with Cirrhosis朗读者：Dr. Stephen Morrissey, NEJM执行主编静脉输入白蛋白首次用于肝硬化患者是在70多年前；血清白蛋白水平低与肝硬化合并感染患者死亡风险增加相关，输入白蛋白可减轻失代偿性肝硬化患者的全身性炎症。但关于白蛋白的临床试验获得了相互矛盾的结果。短视频中总结了新的研究发现。
NEJM医学前沿肝硬化住院患者输入白蛋白的效果小程序
肝硬化住院患者输入白蛋白的随机试验
A Randomized Trial of Albumin Infusions in Hospitalized Patients with Cirrhosis
背景
感染和全身炎症增加会导致失代偿性肝硬化患者发生器官功能障碍和死亡。临床前研究支持白蛋白的抗炎作用，但仍缺乏验证性的大规模临床试验。目前尚未明确与标准治疗相比，这些患者每日重复输入20%人白蛋白溶液（目标是血清白蛋白水平≥30 g/L）可否降低感染、肾功能障碍和死亡的发生率。
Infection and increased systemic inflammation cause organ dysfunction and death in patients with decompensated cirrhosis. Preclinical studies provide support for an antiinflammatory role of albumin, but confirmatory large-scale clinical trials are lacking. Whether targeting a serum albumin level of 30 g per liter or greater in these patients with repeated daily infusions of 20% human albumin solution, as compared with standard care, would reduce the incidences of infection, kidney dysfunction, and death is unknown.
方法
我们在纳入试验时血清白蛋白水平<30 g/L的失代偿性肝硬化住院患者中开展了一项随机、多中心、开放标签、平行组试验。患者被随机分配接受有目标的20%人白蛋白溶液治疗（长达14天或直至出院，以较早的一项为准）或接受标准治疗。治疗在入院后3日内开始。复合主要终点包括开始治疗后第3日至第15日之间的新发感染、肾功能障碍或死亡。
We conducted a randomized, multicenter, open-label, parallel-group trial involving hospitalized patients with decompensated cirrhosis who had a serum albumin level of less than 30 g per liter at enrollment. Patients were randomly assigned to receive either targeted 20% human albumin solution for up to 14 days or until discharge, whichever came first, or standard care. Treatment commenced within 3 days after admission. The composite primary end point was new infection, kidney dysfunction, or death between days 3 and 15 after the initiation of treatment.
结果
共计777例患者接受了随机分组，据报告，饮酒是大多数患者的肝硬化病因。在有目标的白蛋白组（将白蛋白水平提高至≥30 g/L）和标准治疗组中，白蛋白总输入量的中位数分别为每例患者200 g（四分位距，140~280）和每例患者20 g（四分位距，0~120）（校正的平均差，143 g；95%置信区间[CI]，127~158.2）。在有目标的白蛋白组（113/380例患者[29.7%]）和标准治疗组（120/397例患者[30.2%]）之间，发生主要终点事件的患者百分比无显著差异（校正的比值比，0.98；95% CI，0.71~1.33；P=0.87）。在至事件发生的时间分析中，我们在患者出院时或第15日将数据删失，其结果也表明两组无显著差异（风险比，1.04；95% CI，0.81~1.35）。在白蛋白组中，重度或危及生命的严重不良事件的发生率高于标准治疗组
Result
A total of 777 patients underwent randomization, and alcohol was reported to be a cause of cirrhosis in most of these patients. A median total infusion of albumin of 200 g (interquartile range, 140 to 280) per patient was administered to the targeted albumin group (increasing the albumin level to ≥30 g per liter), as compared with a median of 20 g (interquartile range, 0 to 120) per patient administered to the standard-care group (adjusted mean difference, 143 g; 95% confidence interval [CI], 127 to 158.2). The percentage of patients with a primary end-point event did not differ significantly between the targeted albumin group (113 of 380 patients [29.7%]) and the standard-care group (120 of 397 patients [30.2%]) (adjusted odds ratio, 0.98; 95% CI, 0.71 to 1.33; P=0.87). A time-to-event analysis in which data were censored at the time of discharge or at day 15 also showed no significant between-group difference (hazard ratio, 1.04; 95% CI, 0.81 to 1.35). More severe or life-threatening serious adverse events occurred in the albumin group than in the standard-care group.
结论
在英国失代偿性肝硬化住院患者中，输入白蛋白（目标是将白蛋白水平提高至≥30 g/L）的益处并未超过当前标准治疗。（由健康创新基金[Health Innovation Challenge Fund]资助；ATTIRE在EudraCT注册号为2014-002300-24；在ISRCT注册号为N14174793。）
Conclusions
In patients hospitalized with decompensated cirrhosis, albumin infusions to increase the albumin level to a target of 30 g per liter or more was not more beneficial than the current standard care in the United Kingdom. (Funded by the Health Innovation Challenge Fund; ATTIRE EudraCT number, 2014-002300-24; ISRCT number, N14174793.)
Louise China, Nick Freemantle, Ewan Forrest, et al. A Randomized Trial of Albumin Infusions in Hospitalized Patients with Cirrhosis. DOI: 10.1056/NEJMoa2022166
