Efficacy of Albumin Treatment for Patients with Cirrhosis and Infections Unrelated to Spontaneous Bacterial Peritonitis
Efficacy of Albumin Treatment for Patients with Cirrhosis and Infections Unrelated to Spontaneous Bacterial Peritonitis
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DOI：
10.1016/j.cgh.2019.07.055
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发表时间：
2020-04-01
影响因子：
12.6
通讯作者：
Arroyo, Vicente
中科院分区：
文献类型：
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作者：
Fernandez, Javier;Angeli, Paolo;Arroyo, Vicente
背景和目的：我们进行了一项随机试验，以确定是否应该对患有与自发性细菌性腹膜炎 (SBP) 无关的感染的患者施用白蛋白。方法：我们进行了一项多中心、开放标签试验，其中 118 名患有肝硬化、非 SBP 感染和其他不良预后危险因素的患者被随机分配接受抗生素加白蛋白治疗（研究组；n = 61）或单独接受抗生素治疗（对照组；n = 57）。主要结局是院内死亡率；次要结局是白蛋白对病程的影响。 结果：基线时，各组之间的标准实验室测试结果、炎症血清标志物、循环功能障碍或肝脏严重程度评分没有显着差异。然而，研究组中急性慢性肝衰竭 (ACLF) 和肾功能不全的合并患病率显着较高（44.3% vs 对照组的 24.6%；P = .02），表明基线总体严重程度更高。各组之间的主要结局没有显着差异（研究组为 13.1%，对照组为 10.5%；P = .66）。仅研究组的循环和肾功能得到改善。研究组中 ACLF 缓解的患者比例显着较高（82.3% 对比对照组的 33.3%；P = .03）。研究组中发生院内感染的患者比例显着较低（对照组为 6.6%，对照组为 24.6%；P = .007）。 结论：在一项针对晚期肝硬化和非 SBP 感染患者的随机试验中，接受白蛋白加抗生素的患者与仅接受抗生素的患者（对照组）的院内死亡率相似。然而，接受白蛋白治疗的患者在基线时病情较重，并且在随访期间，ACLF 缓解的比例较高，出现院内感染的比例较低。 ClinicalTrials.gov 编号：NCT02034279。
BACKGROUND & AIMS: We performed a randomized trial to determine whether albumin should be administered to patients with infections unrelated to spontaneous bacterial peritonitis (SBP). METHODS: 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.RESULTS: 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).CONCLUSIONS: 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.