当前位置:科学网首页 > 小柯机器人 >详情
供体肾脏低温氧合灌注保存可显著改善肾移植患者的临床结局
作者:小柯机器人 发布时间:2020/11/21 22:53:25

比利时鲁汶大学医院Ina Jochmans团队比较了氧合与标准低温灌注保存在肾移植中对受者预后的影响。2020年11月21日,该研究发表在《柳叶刀》杂志上。

死亡的供体肾脏在低温缺氧条件下得以保存。在保存过程中提供氧气可能改善移植后的结果,特别是对于受保存损伤程度更大的肾。为了调查在低温机器灌注(HMP)期间补充氧气是否可改善循环死亡后捐献肾脏的结局,研究组在欧洲的19个移植中心进行了一项随机、双盲、配对的3期临床试验。

研究组纳入循环死亡后捐赠者年龄在50岁以上、两个肾脏移植给两个不同受者的肾脏对。每个供体的一个肾被随机分配进行低温氧合机器灌注(HMPO2),另一个肾被无氧HMP灌注。从器官取出到植入均维持灌注。主要结局是肾移植后12个月时受者的估计肾小球滤过率(eGFR)。

2015年3月15日至2017年4月11日,研究组将197对肾脏随机分配,其中106对肾脏被移植到合格的接受者中。由于肾衰竭或患者死亡,研究组将23对肾脏排除在主要分析之外。

HMPO2组在12个月时的平均eGFR为50.5 mL/min/1.73 m2,而HMP组为46.7 mL/min/1.73 m2,差异不显著。HMPO2组有11%的患者发生严重并发症,显著低于HMP组(16%)。HMPO2的移植失败率为3%,显著低于HMP组(10%)。

研究组表明,循环死亡后捐献肾脏采用HMPO2保存是安全的,并可减少移植后并发症。但当来自同一供体的两个肾脏都在移植1年后仍起作用时,HMPO2组和HMP组之间12个月的eGFR差异并不显著。

附:英文原文

Title: Oxygenated versus standard cold perfusion preservation in kidney transplantation (COMPARE): a randomised, double-blind, paired, phase 3 trial

Author: Ina Jochmans, Aukje Brat, Lucy Davies, H Sijbrand Hofker, Fenna E M van de Leemkolk, Henri G D Leuvenink, Simon R Knight, Jacques Pirenne, Rutger J Ploeg, Daniel Abramowicz, Neal Banga, Frederike J Bemelman, Michiel GH Betjens, Richéal Burns, Virginia Chiocchia, Maarten HL Christiaans, Tom Darius, Jeroen de Jonge, Aiko PJ de Vries, Olivier Detry, Luuk B Hilbrands, H Sijbrand Hofker, Arjan WJ Hoksbergen, Volkert AL Huurman, Mirza M Idu, Daniel Jacobs-Tulleneers-Thevissen, Ina Jochmans, Maria Kaisar, Nada Kanaan, Diederik Kimenai, Dirk Kuypers, Alain Le Moine, Carl Marshall, Nicolas Meurisse, Dimitri Mikhalski, Cyril Moers, Diethard Monbaliu, Willemijn N Nijboer, S Azam Nurmohamed, John OCallaghan, Vassilios Papalois, Lissa Pipeleers, Paul PC Poyck, Isabel Quiroga, Caren Randon, Geert W Schurink, Marc Seelen, Laszlo Szabo, Raechel J Toorop, Marcel CG van de Poll, Michel FP van der Jagt, Steven Van Laecke, Arjan D van Zuilen, Laurent Weekers, Dirk Ysebaert

Issue&Volume: 2020/11/21

Abstract:

Background

Deceased donor kidneys are preserved in cold hypoxic conditions. Providing oxygen during preservation might improve post-transplant outcomes, particularly for kidneys subjected to greater degrees of preservation injury. This study aimed to investigate whether supplemental oxygen during hypothermic machine perfusion (HMP) could improve the outcome of kidneys donated after circulatory death.

Methods

This randomised, double-blind, paired, phase 3 trial was done in 19 European transplant centres. Kidney pairs from donors aged 50 years or older, donated after circulatory death, were eligible if both kidneys were transplanted into two different recipients. One kidney from each donor was randomly assigned using permuted blocks to oxygenated hypothermic machine perfusion (HMPO 2), the other to HMP without oxygenation. Perfusion was maintained from organ retrieval to implantation. The primary outcome was 12-month estimated glomerular filtration rate (eGFR) using the Chronic Kidney Disease Epidemiology Collaboration equation in pairs of donated kidneys in which both transplanted kidneys were functioning at the end of follow-up. Safety outcomes were reported for all transplanted kidneys. Intention-to-treat analyses were done. This trial is registered with the ISRCTN Registry, ISRCTN32967929, and is now closed.

Findings

Between March 15, 2015, and April 11, 2017, 197 kidney pairs were randomised with 106 pairs transplanted into eligible recipients. 23 kidney pairs were excluded from the primary analysis because of kidney failure or patient death. Mean eGFR at 12 months was 50·5 mL/min per 1·73 m 2 (SD 19·3) in the HMPO 2 group versus 46·7 mL/min per 1·73m 2 (17·1) in HMP (mean difference 3·7 mL/min per 1·73m 2, 95% CI 1·0 to 8·4; p=0·12). Fewer severe complications (Clavien-Dindo grade IIIb or more) were reported in the HMPO 2 group (46 of 417, 11%, 95% CI 8% to 14%) than in the HMP group (76 of 474, 16%, 13% to 20%; p=0·032). Graft failure was lower with HMPO 2 (three [3%] of 106) compared with HMP (11 [10%] of 106; hazard ratio 0·27, 95% CI 0·07 to 0·95; p=0·028).

Interpretation

HMPO 2 of kidneys donated after circulatory death is safe and reduces post-transplant complications (grade IIIb or more). The 12-month difference in eGFR between the HMPO 2 and HMP groups was not significant when both kidneys from the same donor were still functioning 1-year post-transplant, but potential beneficial effects of HMPO 2 were suggested by analysis of secondary outcomes.

DOI: 10.1016/S0140-6736(20)32411-9

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32411-9/fulltext

期刊信息

LANCET:《柳叶刀》,创刊于1823年。隶属于爱思唯尔出版社,最新IF:59.102
官方网址:http://www.thelancet.com/
投稿链接:http://ees.elsevier.com/thelancet