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肝切除术后肝衰竭中的分子吸附循环系统:一项前瞻性I期研究的结果。

The molecular adsorbent recirculating system in posthepatectomy liver failure: Results from a prospective phase I study.

作者信息

Gilg Stefan, Sparrelid Ernesto, Saraste Lars, Nowak Greg, Wahlin Staffan, Strömberg Cecilia, Lundell Lars, Isaksson Bengt

机构信息

Department for Clinical Science, Intervention and Technology Karolinska InstituteStockholmSweden.

Department of Surgery at the Center for Digestive Diseases Karolinska University Hospital Stockholm Sweden.

出版信息

Hepatol Commun. 2018 Mar 8;2(4):445-454. doi: 10.1002/hep4.1167. eCollection 2018 Apr.

Abstract

Posthepatectomy liver failure (PHLF) represents the single most important cause of postoperative mortality after major liver resection, yet no effective treatment option is available. Extracorporeal liver support devices might be helpful, but systematic studies are lacking. Accordingly, we aimed to assess the safety and feasibility of the Molecular Adsorbent Recirculating System (MARS) in patients with PHLF. Between December 2012 and May 2015, a total of 206 patients underwent major or extended hepatectomy, and 10 consecutive patients with PHLF (according to the Balzan 50:50 criteria) were enrolled into the study. MARS treatment was initiated on postoperative day 5-7, and five to seven consecutive treatment sessions were completed for each patient. In total, 59 MARS cycles were implemented, and MARS was initiated and completed without major complications in any patient. However, 1 patient developed an immense asymptomatic hyperbilirubinemia (without encephalopathy), 1 had repeated clotting problems in the MARS filter, and 2 patients experienced access problems with the central venous line. Otherwise, no adverse events were observed. In 9 patients, the bilirubin level and international normalized ratio decreased significantly ( 0.05) during MARS treatment. The 60- and 90-day mortality was 0% and 10%, respectively. Among the 9 survivors, 4 still had liver dysfunction at 90 days postoperatively. Five patients were alive 1 year postoperatively without any signs of liver dysfunction or disease recurrence. The use of MARS in PHLF is feasible and safe and improves liver function in patients with PHLF. In the present study, 60- and 90-day mortality rates were unexpectedly low compared to a historical control group. The impact of MARS treatment on mortality in PHLF should be further evaluated in a randomized controlled clinical trial. ( 2018;2:445-454).

摘要

肝切除术后肝衰竭(PHLF)是大型肝切除术后死亡的最重要单一原因,但目前尚无有效的治疗方法。体外肝支持设备可能会有所帮助,但缺乏系统性研究。因此,我们旨在评估分子吸附循环系统(MARS)用于PHLF患者的安全性和可行性。2012年12月至2015年5月期间,共有206例患者接受了大型或扩大肝切除术,10例连续的PHLF患者(根据Balzan 50:50标准)被纳入研究。MARS治疗于术后第5 - 7天开始,每位患者连续完成5至7个治疗疗程。总共实施了59个MARS治疗周期,所有患者在启动和完成MARS治疗时均未出现重大并发症。然而,1例患者出现巨大无症状高胆红素血症(无肝性脑病),1例在MARS滤器中反复出现凝血问题,2例患者出现中心静脉置管通路问题。除此之外,未观察到其他不良事件。9例患者在MARS治疗期间胆红素水平和国际标准化比值显著下降(P < 0.05)。60天和90天死亡率分别为0%和10%。9名幸存者中,4例在术后90天时仍有肝功能障碍。5例患者术后1年存活,无肝功能障碍或疾病复发迹象。MARS用于PHLF是可行且安全的,并可改善PHLF患者的肝功能。在本研究中,与历史对照组相比,60天和90天死亡率意外地低。MARS治疗对PHLF死亡率的影响应在随机对照临床试验中进一步评估。(2018;2:445 - 454)

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