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中华移植杂志(电子版) ›› 2024, Vol. 18 ›› Issue (06) : 386 -397. doi: 10.3877/cma.j.issn.1674-3903.2024.06.007

专家共识

腹部常温区域机械灌注在以循环标准判定死亡的遗体器官捐献中的临床应用专家共识
中华医学会器官移植学分会   
  • 收稿日期:2024-12-13 出版日期:2024-12-25
  • 基金资助:
    中国器官移植发展基金会科研项目国家卫生健康委员会医疗应急司政府购买服务国家自然科学基金面上项目(81970564,82070670,82170663,82370664,82300744)

Consensus on clinical application of normothermic regional perfusion in donation after circulatory determination of death

of Organ Transplantation of Chinese Medical Association Branch   

  • Received:2024-12-13 Published:2024-12-25
引用本文:

中华医学会器官移植学分会. 腹部常温区域机械灌注在以循环标准判定死亡的遗体器官捐献中的临床应用专家共识[J/OL]. 中华移植杂志(电子版), 2024, 18(06): 386-397.

of Organ Transplantation of Chinese Medical Association Branch. Consensus on clinical application of normothermic regional perfusion in donation after circulatory determination of death[J/OL]. Chinese Journal of Transplantation(Electronic Edition), 2024, 18(06): 386-397.

器官移植是治疗终末期器官疾病的最有效方法。 器官短缺是器官移植领域面临的主要挑战之一。 为此,临床上越来越多地使用包括以循环标准判定死亡的遗体器官捐献(DCDD)在内的扩大标准供者器官。 然而,DCDD 供器官因遭受额外的热缺血损伤,严重影响其移植疗效和器官利用率。 大量临床研究表明,常温区域机械灌注(NRP)技术的应用可显著提高DCDD 供器官质量和移植成功率。 目前,我国尚未制订NRP 技术在DCDD 中临床应用的专家共识,这影响了我国DCDD 的规范化与高质量发展。 为改变这一现状,本文总结国际研究进展,依据循证医学原则深入论证,形成《腹部常温区域机械灌注在以循环标准判定死亡的遗体器官捐献中的临床应用专家共识》。 本共识重点介绍DCDD 过程中应用NRP 技术的执行规范及相应循证医学证据,旨在为NRP 技术在DCDD 供器官移植中应用的规范化、标准化提供参考和指导意见,推动我国NRP 技术和DCDD 供器官移植的快速发展。

Organ transplantation is the most effective treatment for end-stage organ disease.One of the major challenges in organ transplantation is organ shortage.For this reason, more and more extended criteria donor organs including those from donation after circulatory determination of death(DCDD) are used in clinical practice.However, DCDD organs suffer from additional warm ischemic damage, which seriously affects transplant outcomes and organ utilization.Recent studies at home and abroad have shown that the application of normothermic regional perfusion (NRP) is able to improve the quality of organs and the success rate of transplantation.At present, an expert consensus on the clinical application of NRP in DCDD is lacking in China, which limits the standardization and high-quality development of DCDD in our country.We summarized the results of clinical studies and conducted in-depth discussions based on the principles of evidence-based medicine, to form this consensus on application of NRP in DCDD.This consensus focuses on the executive specification and corresponding research evidence of applying NRP technology in DCDD, aiming to provide reference opinions and guidance for the standardization of NRP in organ transplantation, and to promote the rapid development of NRP technology and DCDD organ transplantation in China.

表1 推荐意见分级的评估、制订与评价系统
表2 腹部NRP 期间肝脏评价标准汇总
国家 作者 年份 供肝接受标准
法国 Champigneulle 等[44] 2015 AST/ ALT <200 IU/ L(若连续2 次测量>200 IU/ L,应弃用供肝);活检提示脂肪变性<15% ~20%,且无纤维化
Savier 等[45] 2015 AST/ ALT <200 IU/ L(若连续2 次测量>200 IU/ L,应弃用供肝)
Antoine 等[26] 2020 NRP 期间AST/ ALT 水平<4 倍正常上限(≥3 次测量值),活检提示大泡型脂肪变性< 20%,且< 中度纤维化
Muller 等[46] 2020 NRP 期间AST/ ALT 水平<4 倍正常上限,活检提示大泡型脂肪变性<20%
西班牙 Otero 等[47] 2003 活检提示脂肪变性<30%且无慢性肝病征象
Fondevila 等[48] 2007 正常大体外观,活检提示大泡型脂肪变性<30%,无血管性的胆总管功能异常
Jiménez-Galanes 等[49] 2009 NRP 期间AST/ ALT 最高水平<4 倍正常上限
Fondevila 等[6] 2012 无淤血或灌注不良,无脂肪变性或纤维化,无血管性的胆总管功能异常
Rojas-Peña 等[34] 2014 正常大体外观
Miñambres 等[50] 2017 NRP 期间AST/ ALT 最高水平<4 倍正常上限
Jiménez-Romero 等[51] 2019 NRP 期间AST/ ALT 最高水平<4 倍正常上限,正常大体外观,活检提示大泡型脂肪变性<30%
Ruiz 等[52] 2019 NRP 初始AST/ ALT 水平<3 倍正常上限,终末AST/ ALT 水平<4 倍正常上限
Miñambres 等[53] 2020 NRP 期间AST/ ALT 最高水平<4 倍正常上限,正常大体外观
意大利 De Carlis 等[54] 2017 NRP 期间ALT <1 000 IU/ L,血清乳酸水平呈持续下降趋势,正常大体外观,活检提示大泡型脂肪变性<30%且纤维化Ishad 评分<1 分
De Carlis 等[55] 2018 满足≥3 条下述标准:ALT <1 000 IU/ L,血清乳酸水平呈持续下降趋势,正常大体外观,活检提示大泡型脂肪变性<30%且纤维化Ishad 评分<1 分
英国 Butler 等[33] 2014 正常大体外观且基线ALT <200 IU/ L
Oniscu 等[56] 2014 NRP 初始AST/ ALT 水平<3 倍正常上限,终末AST/ ALT 水平<4 倍正常上限,正常大体外观
Georgiades 等[57] 2019 AST/ ALT 水平稳定,血清乳酸水平呈持续下降趋势
Watson 等[8] 2019 正常大体外观,ALT 和血清乳酸水平均呈持续下降趋势
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