EF Clif, EASL-CLIF Consortium and Grifols Chair, Barcelona, Spain; Hospital Clínic, IDIBAPS and CIBERehd, Barcelona, Spain.
EF Clif, EASL-CLIF Consortium and Grifols Chair, Barcelona, Spain; University of Padua, Padua, Italy.
Clin Gastroenterol Hepatol. 2020 Apr;18(4):963-973.e14. doi: 10.1016/j.cgh.2019.07.055. Epub 2019 Aug 5.
BACKGROUND & AIMS: We performed a randomized trial to determine whether albumin should be administered to patients with infections unrelated to spontaneous bacterial peritonitis (SBP).
We performed a multicenter, open-label trial in which 118 patients with cirrhosis, non-SBP infections, and additional risk factors for poor outcome were randomly assigned to receive antibiotics plus albumin (study group; n = 61) or antibiotics alone (control group; n = 57). The primary outcome was in-hospital mortality; secondary outcomes were effect of albumin on disease course.
There were no significant differences at baseline between groups in results from standard laboratory tests, serum markers of inflammation, circulatory dysfunction, or liver severity scores. However, the combined prevalence of acute on chronic liver failure (ACLF) and kidney dysfunction was significantly higher in the study group (44.3% vs 24.6% in the control group; P = .02), indicating greater baseline overall severity. There was no significant difference in the primary outcome between groups (13.1% in the study group vs 10.5% in the control group; P = .66). Circulatory and renal functions improved in only the study group. A significantly higher proportion of patients in the study group had resolution of ACLF (82.3% vs 33.3% in the control group; P = .03). A significantly lower proportion of patients in the study group developed nosocomial infections (6.6% vs 24.6% in the control group; P = .007).
In a randomized trial of patients with advanced cirrhosis and non-SBP infections, in-hospital mortality was similar between those who received albumin plus antibiotics vs those who received only antibiotics (controls). However, patients given albumin were sicker at baseline and, during the follow-up period, a higher proportion had ACLF resolution and a lower proportion had nosocomial infections. ClinicalTrials.gov no: NCT02034279.
我们进行了一项随机试验，以确定是否应向与自发性细菌性腹膜炎（SBP）无关的感染患者输注白蛋白。
我们进行了一项多中心、开放性试验，其中 118 例肝硬化、非 SBP 感染且伴有不良预后其他危险因素的患者被随机分为接受抗生素加白蛋白（研究组；n=61）或单独接受抗生素（对照组；n=57）。主要结局为院内死亡率；次要结局为白蛋白对病程的影响。
两组患者的基线标准实验室检查、炎症血清标志物、循环功能障碍或肝脏严重程度评分均无显著差异。然而，研究组的急性失代偿性肝衰竭（ACLF）和肾功能障碍的联合患病率显著更高（44.3%比对照组的 24.6%；P=0.02），表明基线整体严重程度更高。两组的主要结局无显著差异（研究组为 13.1%，对照组为 10.5%；P=0.66）。仅研究组的循环和肾功能得到改善。研究组中有更高比例的患者 ACLF 得到缓解（82.3%比对照组的 33.3%；P=0.03）。研究组中有更低比例的患者发生医院感染（6.6%比对照组的 24.6%；P=0.007）。
在一项患有晚期肝硬化和非 SBP 感染的患者的随机试验中，接受白蛋白加抗生素治疗的患者与仅接受抗生素治疗的患者（对照组）的院内死亡率相似。然而，接受白蛋白治疗的患者基线时病情更重，在随访期间，有更高比例的患者 ACLF 得到缓解，而发生医院感染的比例更低。ClinicalTrials.gov 编号：NCT02034279。
