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

doi:10.3877/cma.j.issn.1674-3903.2024.06.007

Abstract

Abstract:

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.

Key words: Donation after circulatory determination of death, Normothermic regional perfusion, Organ transplantation, Implementation standards

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

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证据级别	定义
Ⅰ	同质RCT 的系统评价
	单个RCT(可信区间窄)
	“全或无”病案系列研究
Ⅱ	同质队列研究的系统评价
	单个队列研究(包括低质量RCT,如随访率<80%)
	结果研究,生态学研究
Ⅲ	同质病例对照研究的系统评价
	单个病例对照研究
Ⅳ	病例系列研究(包括低质量队列及病例对照研究)
Ⅴ	基于经验未严格论证的专家意见

证据级别	定义
Ⅰ	同质RCT 的系统评价
	单个RCT(可信区间窄)
	“全或无”病案系列研究
Ⅱ	同质队列研究的系统评价
	单个队列研究(包括低质量RCT,如随访率<80%)
	结果研究,生态学研究
Ⅲ	同质病例对照研究的系统评价
	单个病例对照研究
Ⅳ	病例系列研究(包括低质量队列及病例对照研究)
Ⅴ	基于经验未严格论证的专家意见

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

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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