Bednarsch Jan, Czigany Zoltan, Loosen Sven H, Heij Lara, Ruckgaber Lorenz, Maes Henning, Krause Jan-Pit, Reen Matthias, Toteva Beata, Vosdellen Theresa, Bruners Philipp, Lang Sven Arke, Ulmer Tom Florian, Roderburg Christoph, Luedde Tom, Neumann Ulf Peter
Department of Surgery and Transplantation, University Hospital RWTH Aachen, Pauwelsstrasse 30, 52074, Aachen, Germany.
Department of Medicine III, University Hospital RWTH Aachen, Aachen, Germany.
Sci Rep. 2021 Sep 9;11(1):17936. doi: 10.1038/s41598-021-97442-w.
The objective of this randomized controlled trial (RCT) was to assess the impact of rifaximin on the course of liver function, liver regeneration and volumetric recovery in patients undergoing major hepatectomy. The ARROW trial was an investigator initiated, single-center, open-label, phase 3 RCT with two parallel treatment groups, conducted at our hepatobiliary center from 03/2016 to 07/2020. Patients undergoing major hepatectomy were eligible and randomly assigned 1:1 to receive oral rifaximin (550 mg twice daily for 7-10 or 14-21 days in case of portal vein embolization preoperatively and 7 days postoperatively) versus no intervention. Primary endpoint was the relative increase in postoperative liver function measured by LiMAx from postoperative day (POD) 4 to 7. Secondary endpoint were the course of liver function and liver volume during the study period as well as postoperative morbidity and mortality. Between 2016 and 2020, 45 patients were randomized and 35 patients (16 individuals in the rifaximin and 19 individuals in the control group) were eligible for per-protocol analysis. The study was prematurely terminated following interim analysis, due to the unlikelihood of reaching a significant primary endpoint. The median relative increase in liver function from POD 4 to POD 7 was 27% in the rifaximin group and 41% in the control group (p = 0.399). Further, no significant difference was found in terms of any other endpoints of functional liver- and volume regeneration or perioperative surgical complications following the application of rifaximin versus no intervention. Perioperative application of rifaximin has no effect on functional or volumetric regeneration after major hepatectomy (NCT02555293; EudraCT 2013-004644-28).
这项随机对照试验（RCT）的目的是评估利福昔明对接受大肝切除术患者的肝功能、肝再生和体积恢复过程的影响。ARROW试验是一项由研究者发起的、单中心、开放标签的3期RCT，有两个平行治疗组，于2016年3月至2020年7月在我们的肝胆中心进行。接受大肝切除术的患者符合条件，并按1:1随机分配接受口服利福昔明（术前门静脉栓塞患者每天两次，每次550mg，共7 - 10天或14 - 21天，术后7天）与不进行干预。主要终点是术后第4天至第7天通过LiMAx测量的术后肝功能相对增加。次要终点是研究期间的肝功能和肝体积过程以及术后发病率和死亡率。2016年至2020年期间，45例患者被随机分组，35例患者（利福昔明组16例，对照组19例）符合符合方案分析的条件。由于不太可能达到显著的主要终点，该研究在中期分析后提前终止。利福昔明组术后第4天至第7天肝功能的中位数相对增加为27%，对照组为41%（p = 0.399）。此外，在应用利福昔明与不进行干预后，在功能性肝再生和体积再生或围手术期手术并发症的任何其他终点方面未发现显著差异。围手术期应用利福昔明对大肝切除术后的功能性或体积再生没有影响（NCT编号：02555293；欧盟临床试验编号：2013 - 004644 - 28）。
