中国儿童肺移植临床诊疗指南

doi:10.3877/cma.j.issn.1674-3903.2026.01.001

儿童肺移植是目前治疗终末期肺病患儿的唯一有效手段。近年来，随着我国器官捐献及移植事业的不断发展，儿童肺移植例数逐渐增加。然而，由于我国儿童肺移植起步较晚，各中心发展水平不一，移植疗效差异明显，且缺乏统一的行业共识与管理规范。基于此，由多学科专家经充分讨论与循证分析共同制定《中国儿童肺移植临床诊疗指南》，聚焦儿童肺移植的关键环节，提出科学、规范的诊疗原则，旨在提高患儿短期及远期生存率，促进我国儿童肺移植工作的规范化、标准化与高质量发展。

关键词: 儿童肺移植, 适应证, 禁忌证, 术前评估与管理, 手术策略, 术后管理

Pediatric lung transplantation is currently the only effective treatment for children with end-stage lung disease. In recent years, with the continuous advancement of organ donation and transplantation in China, the number of pediatric lung transplant procedures has gradually increased. However, given the relatively late initiation of pediatric lung transplantation in China, the development across centers remains uneven, clinical outcomes vary significantly, and unified professional consensus and management standards are lacking. To address these challenges, this guideline was developed through extensive discussion and evidence-based analysis by a multidisciplinary panel of experts. It focuses on key aspects of pediatric lung transplantation and proposes scientific and standardized principles for clinical practice, with the aim of improving both short- and long-term survival in pediatric recipients and promoting the normalization, standardization, and high-quality development of pediatric lung transplantation in China.

Key words: Pediatric lung transplantation, Indications, Contraindications, Preoperative evaluation and management, Surgical strategy, Postoperative management

表1 牛津大学证据分级与推荐意见强度分级标准

推荐强度	证据级别	描述
A	1a	RCTs的系统评价
	1b	结果可信区间小的RCT
	1c	显示"全或无效应"的任何证据
B	2a	队列研究的系统评价
	2b	单个的队列研究(包括低质量的RCT，如失访率>20%)
	2c	基于患者结局的研究
	3a	病例对照研究的系统评价
	3b	单个病例对照研究
C	4	病例系列报告、低质量队列研究和低质量病例对照研究
D	5	专家意见(即无临床研究支持的仅依据基础研究或临床经验的推测)

表1 牛津大学证据分级与推荐意见强度分级标准

推荐强度	证据级别	描述
A	1a	RCTs的系统评价
	1b	结果可信区间小的RCT
	1c	显示"全或无效应"的任何证据
B	2a	队列研究的系统评价
	2b	单个的队列研究(包括低质量的RCT，如失访率>20%)
	2c	基于患者结局的研究
	3a	病例对照研究的系统评价
	3b	单个病例对照研究
C	4	病例系列报告、低质量队列研究和低质量病例对照研究
D	5	专家意见(即无临床研究支持的仅依据基础研究或临床经验的推测)

表2 儿童肺移植常见适应证的转诊时机

常见适应证	转诊时机
囊性纤维化	(1)FEV1<50%预测值，并伴有6 min步行速度慢(<400 m)、低氧血症(PaO₂<8 kPa或<60 mmHg)、高碳酸血症(PaCO₂>6.6 kPa或>50 mmHg)或肺动脉高压(mPAP>25 mmHg) (2)FEV1<50%预测值，伴FEV1快速下降 (3)FEV1<40%预测值
PAH	(1)符合EPPVDN发布的儿童PAH共识中评估结果为中或高风险等级的患儿 (2)尽管进行干预，但营养状况和生长仍继续恶化 (3)呼吸衰竭，长期无创通气 (4)右心衰竭的临床证据，生长落后 (5)WHO心功能分级Ⅲ~Ⅳ级(6)疾病相关的继发性肝或肾功能障碍的体征，反复咯血或晕厥 (7)需前列环素治疗 (8)BNP或NT-proBNP水平显著升高 (9)超声心动图检查：右心房和心室严重扩大，左、右心室收缩功能障碍 (10)侵入性血流动力学指标：心指数<2.5 L·min^－1·(m²)^－1, mPAP/mSAP>0.75, mRAP>14 mmHg, RVRi>15 WUm² (11)尽管进行适当治疗或近期因PAH恶化而住院治疗，但疾病仍进展 (12)正在考虑进行房间隔造口术或反向Potts分流术作为姑息性手术(移植可能是术后选择)
间质性肺疾病	(1)有间质性肺病的组织学证据和进行性肺功能下降 (2)进行性PAH (3)经组织病理学证实或X线影像学检查确诊为寻常型间质性肺炎 (4)任何形式的肺纤维化，且FVC<80%或DLCO<40% (5)任何形式的肺纤维化且过去2年内出现以下任一项：FVC≥10%、DLCO≥15%、FVC≥5%同时伴有呼吸道症状恶化或影像学进展 (6)需要辅助供氧 (7)尽管接受治疗，但炎症仍继续进展
肺表面活性物质缺乏	(1)SP-B和ABCA3功能障碍伴难治性呼吸衰竭 (2)SP-C、NKX2.1和不严重的ABCA3功能障碍伴疾病进展 (3)进行性PAH
闭塞性细支气管炎	(1)BODE评分5~6分，并有以下提示死亡风险增加的指标：①≥3次急性加重；②过去2年内BODE评分增加>1分；③CT显示肺动脉直径/主动脉直径>1；④FEV1占20%~25%预测值 (2)BODE评分≥7分 (3)FEV1<20%预测值 (4)中重度PAH (5)慢性高碳酸血症 (6)严重急性加重 (7)充分治疗后症状仍恶化 (8)生活质量差 (9)需接受肺减容术
支气管肺发育不良	(1)严重呼吸衰竭 (2)进行性PAH
艾森曼格综合征	(1)进行性PAH (2)运动耐量受损 (3)生活质量恶化

表2 儿童肺移植常见适应证的转诊时机

常见适应证	转诊时机
囊性纤维化	(1)FEV1<50%预测值，并伴有6 min步行速度慢(<400 m)、低氧血症(PaO₂<8 kPa或<60 mmHg)、高碳酸血症(PaCO₂>6.6 kPa或>50 mmHg)或肺动脉高压(mPAP>25 mmHg) (2)FEV1<50%预测值，伴FEV1快速下降 (3)FEV1<40%预测值
PAH	(1)符合EPPVDN发布的儿童PAH共识中评估结果为中或高风险等级的患儿 (2)尽管进行干预，但营养状况和生长仍继续恶化 (3)呼吸衰竭，长期无创通气 (4)右心衰竭的临床证据，生长落后 (5)WHO心功能分级Ⅲ~Ⅳ级(6)疾病相关的继发性肝或肾功能障碍的体征，反复咯血或晕厥 (7)需前列环素治疗 (8)BNP或NT-proBNP水平显著升高 (9)超声心动图检查：右心房和心室严重扩大，左、右心室收缩功能障碍 (10)侵入性血流动力学指标：心指数<2.5 L·min^－1·(m²)^－1, mPAP/mSAP>0.75, mRAP>14 mmHg, RVRi>15 WUm² (11)尽管进行适当治疗或近期因PAH恶化而住院治疗，但疾病仍进展 (12)正在考虑进行房间隔造口术或反向Potts分流术作为姑息性手术(移植可能是术后选择)
间质性肺疾病	(1)有间质性肺病的组织学证据和进行性肺功能下降 (2)进行性PAH (3)经组织病理学证实或X线影像学检查确诊为寻常型间质性肺炎 (4)任何形式的肺纤维化，且FVC<80%或DLCO<40% (5)任何形式的肺纤维化且过去2年内出现以下任一项：FVC≥10%、DLCO≥15%、FVC≥5%同时伴有呼吸道症状恶化或影像学进展 (6)需要辅助供氧 (7)尽管接受治疗，但炎症仍继续进展
肺表面活性物质缺乏	(1)SP-B和ABCA3功能障碍伴难治性呼吸衰竭 (2)SP-C、NKX2.1和不严重的ABCA3功能障碍伴疾病进展 (3)进行性PAH
闭塞性细支气管炎	(1)BODE评分5~6分，并有以下提示死亡风险增加的指标：①≥3次急性加重；②过去2年内BODE评分增加>1分；③CT显示肺动脉直径/主动脉直径>1；④FEV1占20%~25%预测值 (2)BODE评分≥7分 (3)FEV1<20%预测值 (4)中重度PAH (5)慢性高碳酸血症 (6)严重急性加重 (7)充分治疗后症状仍恶化 (8)生活质量差 (9)需接受肺减容术
支气管肺发育不良	(1)严重呼吸衰竭 (2)进行性PAH
艾森曼格综合征	(1)进行性PAH (2)运动耐量受损 (3)生活质量恶化

表3 儿童肺移植适应证分类及诊断

分类	类别诊断
先天性遗传性疾病	支气管肺发育不良，原发性纤毛运动障碍，α1-抗胰蛋白酶缺乏症，肺表面活性物质代谢障碍(如ABCA3突变、表面活性蛋白B/C缺乏症)等
囊性纤维化	囊性纤维化
间质性肺病	特发性肺纤维化，BO伴机化性肺炎/隐源性机化性肺炎，脱屑性间质性肺炎，淋巴细胞间质性肺炎，非特异性间质性肺炎，ARDS/肺炎，间质性肺炎，肺泡蛋白沉积症，肺淀粉样变，婴幼儿慢性肺炎，朗格汉斯细胞组织细胞增生症，过敏性肺炎，特发性肺含铁血黄素沉着症，吸入性烧伤/外伤，肺毛细血管扩张症，硬皮病等
肺动脉高压	特发性肺动脉高压
非特发性肺动脉高压	先天性畸形，其他先天性原因，艾森曼格综合征(房间隔缺损、多发性先天性畸形、动脉导管未闭、室间隔缺损等)，门脉性肺动脉高压，肺毛细血管瘤病，肺血管疾病，肺静脉闭塞症，肺动脉瓣狭窄，继发性肺动脉高压
BO(非再次移植)	BO(非再次移植)
二次移植	由于以下原因移植失败，再次移植：急性排斥反应，原发性移植物失功，BO，限制性移植物功能障碍，其他
其他	肉芽肿性肺病(结节病、Wegener肉芽肿)，免疫缺陷及免疫相关性肺病(支气管肺曲霉病、普通变异性免疫缺陷病、移植物抗宿主病)，Swyer-James综合征，其他罕见肺病

表3 儿童肺移植适应证分类及诊断

分类	类别诊断
先天性遗传性疾病	支气管肺发育不良，原发性纤毛运动障碍，α1-抗胰蛋白酶缺乏症，肺表面活性物质代谢障碍(如ABCA3突变、表面活性蛋白B/C缺乏症)等
囊性纤维化	囊性纤维化
间质性肺病	特发性肺纤维化，BO伴机化性肺炎/隐源性机化性肺炎，脱屑性间质性肺炎，淋巴细胞间质性肺炎，非特异性间质性肺炎，ARDS/肺炎，间质性肺炎，肺泡蛋白沉积症，肺淀粉样变，婴幼儿慢性肺炎，朗格汉斯细胞组织细胞增生症，过敏性肺炎，特发性肺含铁血黄素沉着症，吸入性烧伤/外伤，肺毛细血管扩张症，硬皮病等
肺动脉高压	特发性肺动脉高压
非特发性肺动脉高压	先天性畸形，其他先天性原因，艾森曼格综合征(房间隔缺损、多发性先天性畸形、动脉导管未闭、室间隔缺损等)，门脉性肺动脉高压，肺毛细血管瘤病，肺血管疾病，肺静脉闭塞症，肺动脉瓣狭窄，继发性肺动脉高压
BO(非再次移植)	BO(非再次移植)
二次移植	由于以下原因移植失败，再次移植：急性排斥反应，原发性移植物失功，BO，限制性移植物功能障碍，其他
其他	肉芽肿性肺病(结节病、Wegener肉芽肿)，免疫缺陷及免疫相关性肺病(支气管肺曲霉病、普通变异性免疫缺陷病、移植物抗宿主病)，Swyer-James综合征，其他罕见肺病

表4 儿童肺移植候选者评估内容

分类	内容
原发病评估	起病时间、发病症状、临床诊断、病理诊断、基因检测、疾病进展和治疗经过、氧疗情况、一般情况(睡眠、食欲、大小便、体重变化等)、伴随疾病、有无先天性发育异常、既往移植情况(如骨髓移植)、输血史、手术史、股动静脉插管史、过敏史及家族史等
体格检查	一般状态、发育情况(包括身高、体重、头围、胸围、上臂围)、五官、皮肤毛发、心肺检查、腹部检查、泌尿生殖系统检查、脊柱以及四肢检查等
实验室检查	血型、血常规、凝血功能、生化检查(电解质、肝肾功能)、血脂、心肌酶、脑钠肽、降钙素原以及血清学检测(CMV、EB病毒、HIV、HBV、HCV、麻疹病毒、水痘-带状疱疹病毒、单纯疱疹病毒、弓形虫等；对于异基因造血干细胞移植后患儿，如果免疫功能尚未恢复正常，建议进行上述病原的核酸检测，以避免假阴性)；HLA配型、群体反应性抗体检测、动脉血气、自身免疫性疾病筛查(类风湿因子、抗核抗体、抗中性粒细胞胞质抗体、免疫球蛋白)、甲状腺激素、骨代谢指标、糖化血红蛋白、尿常规、粪便常规、肿瘤标志物等
微生物检查	痰或咽拭子培养及药敏试验、结核菌素试验、γ-干扰素释放试验(T-SPOT试验)、结核菌涂片检查、G试验/GM试验、梅毒检测等
心肺功能评估	肺功能评估、6 min步行试验、心电图、心导管术(必要时)、右心功能检测
影像学检查	胸部X线、胸部CT、肺灌注/通气显像、鼻窦CT(囊性纤维化或免疫缺陷患儿)、超声心动图、冠状动脉CTA或DSA(必要时)、骨密度、超声(腹部、下肢血管、颈部血管、泌尿系统、甲状腺)
生长发育与营养状态	身高、体重、体质指数、最大腹围、上臂围、肱三头肌皮褶厚度、神经认知发育指标等；疫苗接种史(如肺炎球菌、乙型肝炎、麻疹、腮腺炎、风疹、水痘等疫苗)
心理社会评估	心理状态：患儿疾病认知水平、负面自我感知情绪以及移植可能产生的心理压力依从性：患儿整体治疗决策中的自主性和治疗依从性家庭情况和社会支持：针对家庭组成架构、经济能力状况、社会支持网络以及能否为移植后提供必需的护理和支持等方面的评估

表4 儿童肺移植候选者评估内容

分类	内容
原发病评估	起病时间、发病症状、临床诊断、病理诊断、基因检测、疾病进展和治疗经过、氧疗情况、一般情况(睡眠、食欲、大小便、体重变化等)、伴随疾病、有无先天性发育异常、既往移植情况(如骨髓移植)、输血史、手术史、股动静脉插管史、过敏史及家族史等
体格检查	一般状态、发育情况(包括身高、体重、头围、胸围、上臂围)、五官、皮肤毛发、心肺检查、腹部检查、泌尿生殖系统检查、脊柱以及四肢检查等
实验室检查	血型、血常规、凝血功能、生化检查(电解质、肝肾功能)、血脂、心肌酶、脑钠肽、降钙素原以及血清学检测(CMV、EB病毒、HIV、HBV、HCV、麻疹病毒、水痘-带状疱疹病毒、单纯疱疹病毒、弓形虫等；对于异基因造血干细胞移植后患儿，如果免疫功能尚未恢复正常，建议进行上述病原的核酸检测，以避免假阴性)；HLA配型、群体反应性抗体检测、动脉血气、自身免疫性疾病筛查(类风湿因子、抗核抗体、抗中性粒细胞胞质抗体、免疫球蛋白)、甲状腺激素、骨代谢指标、糖化血红蛋白、尿常规、粪便常规、肿瘤标志物等
微生物检查	痰或咽拭子培养及药敏试验、结核菌素试验、γ-干扰素释放试验(T-SPOT试验)、结核菌涂片检查、G试验/GM试验、梅毒检测等
心肺功能评估	肺功能评估、6 min步行试验、心电图、心导管术(必要时)、右心功能检测
影像学检查	胸部X线、胸部CT、肺灌注/通气显像、鼻窦CT(囊性纤维化或免疫缺陷患儿)、超声心动图、冠状动脉CTA或DSA(必要时)、骨密度、超声(腹部、下肢血管、颈部血管、泌尿系统、甲状腺)
生长发育与营养状态	身高、体重、体质指数、最大腹围、上臂围、肱三头肌皮褶厚度、神经认知发育指标等；疫苗接种史(如肺炎球菌、乙型肝炎、麻疹、腮腺炎、风疹、水痘等疫苗)
心理社会评估	心理状态：患儿疾病认知水平、负面自我感知情绪以及移植可能产生的心理压力依从性：患儿整体治疗决策中的自主性和治疗依从性家庭情况和社会支持：针对家庭组成架构、经济能力状况、社会支持网络以及能否为移植后提供必需的护理和支持等方面的评估

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Clinical practice guidelines for pediatric lung transplantation in China

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Clinical practice guidelines for pediatric lung transplantation in China