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特利加压素在入住重症监护病房的肝肾综合征-急性肾损伤患者中的作用:CONFIRM试验的一项子研究

Role of Terlipressin in Patients With Hepatorenal Syndrome-Acute Kidney Injury Admitted to the ICU: A Substudy of the CONFIRM Trial.

作者信息

Karvellas Constantine J, Subramanian Ram, Olson Jody C, Jamil Khurram

机构信息

Department of Critical Care Medicine and Division of Gastroenterology (Liver Unit), University of Alberta, Edmonton, AB, Canada.

Departments of Critical Care Medicine and Hepatology, Emory University, Atlanta, GA.

出版信息

Crit Care Explor. 2023 Mar 28;5(4):e0890. doi: 10.1097/CCE.0000000000000890. eCollection 2023 Apr.

Abstract

UNLABELLED

This study assessed the potential advantages of treating hepatorenal syndrome-acute kidney injury (HRS-AKI) with terlipressin versus placebo in the ICU setting.

DESIGN

Patients were randomly assigned in a 2:1 ratio to receive terlipressin or placebo for up to 14 days.

SETTING

A retrospective analysis of data from the phase III CONFIRM study.

PARTICIPANTS

Adult patients with HRS-AKI admitted to the ICU.

MAIN OUTCOMES AND MEASURES

In this substudy, we evaluated outcomes of the ICU stay and the need for organ support, including renal replacement therapy (RRT).

RESULTS

Among 300 patients with HRS-AKI from the CONFIRM study, 45 were treated in the ICU (terlipressin, 31/199 [16%]; placebo, 14/101 [14%]). On ICU admission, baseline demographics were similar across treatment arms, including severity of liver dysfunction. Among patients alive at the end of the ICU stay, those randomized to terlipressin had a significantly shorter median length of ICU stay than placebo (4 vs 11 d; < 0.001). Terlipressin-treated patients had a significantly larger improvement in renal function from baseline versus placebo (-0.7 vs +0.2 mg/dL; = 0.001), including when accounting for the interaction between treatment and day-of-patient-admission to the ICU (-0.7 vs +0.9 mg/dL; < 0.001). Cumulative requirement for RRT through day 90 was improved in the terlipressin arm versus placebo (10/31 [32%] vs 8/14 [57%]; = 0.12), although not significantly. Of 13 patients who received a liver transplant, five out of five (100%) in the placebo arm needed RRT through day 90 versus five out of eight (63%) in the terlipressin arm.

CONCLUSIONS

In this subanalysis of CONFIRM, patients admitted to the ICU with HRS-AKI who received terlipressin were more likely to achieve renal function improvement, based on serum creatinine changes by the end of treatment, and had significantly shorter lengths of ICU stay than patients randomized to the placebo arm.

摘要

未标注

本研究评估了在重症监护病房(ICU)环境中,用特利加压素治疗肝肾综合征-急性肾损伤(HRS-AKI)相对于安慰剂的潜在优势。

设计

患者按2:1的比例随机分配,接受特利加压素或安慰剂治疗,最长14天。

设置

对III期CONFIRM研究的数据进行回顾性分析。

参与者

入住ICU的HRS-AKI成年患者。

主要结局和测量指标

在这项子研究中,我们评估了ICU住院结局以及对器官支持的需求,包括肾脏替代治疗(RRT)。

结果

在CONFIRM研究的300例HRS-AKI患者中,45例在ICU接受治疗(特利加压素组,31/199 [16%];安慰剂组,14/101 [14%])。在入住ICU时,各治疗组的基线人口统计学特征相似,包括肝功能障碍的严重程度。在ICU住院结束时存活的患者中,随机接受特利加压素治疗的患者的ICU住院中位时间显著短于安慰剂组(4天对11天;P<0.001)。与安慰剂组相比,接受特利加压素治疗的患者肾功能从基线的改善更为显著(-0.7对+0.2mg/dL;P = 0.001),包括考虑治疗与患者入住ICU日期之间的相互作用时(-0.7对+0.9mg/dL;P<0.001)。到第90天时,特利加压素组的RRT累积需求相对于安慰剂组有所改善(10/31 [32%]对8/14 [57%];P = 0.12),尽管未达到显著差异。在13例接受肝移植的患者中,安慰剂组的5例患者(100%)到第90天时需要RRT,而特利加压素组的8例患者中有5例(63%)需要RRT。

结论

在CONFIRM研究的这项子分析中,入住ICU的HRS-AKI患者接受特利加压素治疗后,根据治疗结束时血清肌酐变化,更有可能实现肾功能改善,且其ICU住院时间显著短于随机分配至安慰剂组的患者。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f8a6/10060094/5b8539fdbf46/cc9-5-e0890-g001.jpg

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