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Article(id=1199335049771450377, tenantId=1146029695717560320, journalId=1189873630562394117, issueId=1199335049175859209, articleNumber=null, orderNo=null, doi=10.11855/j.issn.0577-7402.0467.2023.0717, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=research-article, receivedDate=1680105600000, receivedDateStr=2023-03-30, revisedDate=null, revisedDateStr=null, acceptedDate=1689004800000, acceptedDateStr=2023-07-11, onlineDate=1763873358433, onlineDateStr=2025-11-23, pubDate=1711555200000, pubDateStr=2024-03-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1763873358433, onlineIssueDateStr=2025-11-23, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1763873358433, creator=13701087609, updateTime=1763873358433, updator=13701087609, issue=Issue{id=1199335049175859209, tenantId=1146029695717560320, journalId=1189873630562394117, year='2024', volume='49', issue='3', pageStart='245', pageEnd='366', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=0, createTime=1763873358291, creator=13701087609, updateTime=1763874044185, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1199337926086721596, tenantId=1146029695717560320, journalId=1189873630562394117, issueId=1199335049175859209, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1199337926086721597, tenantId=1146029695717560320, journalId=1189873630562394117, issueId=1199335049175859209, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=245, endPage=251, ext={EN=ArticleExt(id=1199335050027302924, articleId=1199335049771450377, tenantId=1146029695717560320, journalId=1189873630562394117, language=EN, title=Evolution and considerations of diagnostic criteria for neonatal acute respiratory distress syndrome, columnId=1199335049955999755, journalTitle=Medical Journal of Chinese People’s Liberation Army, columnName=Special Issue of Diagnosis and Treatment of Neonatal Respiratory Distress Syndrome, runingTitle=null, highlight=null, articleAbstract=

Since acute respiratory distress syndrome (ARDS) was firstly reported in 1967, the diagnostic criteria and classification standard have evolved continually. Neonatal ARDS has drawn increasing attention in recent years, while research on neonatal ARDS has proceeded slowly, partly because of ambiguity in the definitions and diagnostic criteria of neonatal ARDS. In this comment, we overview the application of the Berlin definition made in 2012, the Montreux definition made in 2017, and the definition of pediatric ARDS update by the Second Pediatric Acute Lung Injury Consensus Conference made in 2023 (PALICC-2 definition) in neonatal ARDS, then compare the similarities and differences among the three definitions. Finally, the differences in classification standard, triggers, morbidity, mortality, poor prognosis, and treatment among the three definitions for neonatal ARDS were analyzed, and the research directions in the future of the definition for neonatal ARDS were proposed.

, correspAuthors=Yuan Shi, authorNote=null, correspAuthorsNote=
E-mail:
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自1967年急性呼吸窘迫综合征(ARDS)首次被报道以来，其诊断及分级标准不断演变。近年来，新生儿ARDS越来越受到关注，然而其研究进展缓慢，部分原因是诊断标准仍存在争议。本文就2012年柏林标准、2017年蒙特勒标准和2023年第二届小儿急性肺损伤共识会议更新的儿童ARDS诊断标准(PALICC-2标准)在新生儿ARDS中的应用进行概述，比较3种诊断标准的异同，分析3种诊断标准应用于新生儿ARDS时其分级标准、触发因素、发病率、病死率、不良预后和治疗等的差异，并提出未来新生儿ARDS诊断标准的研究方向。

, correspAuthors=史源, authorNote=null, correspAuthorsNote=
史源，E-mail：
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刘立婷，博士研究生，主治医师，主要从事新生儿感染、新生儿急性呼吸窘迫综合征等方面的研究

史源，主任医师，教授，博士研究生导师。重庆医科大学附属儿童医院新生儿诊疗中心主任，国家重点研发计划首席专家，国家临床重点专科带头人，荣获首批“重庆英才创新领军人才”称号，重庆市学术技术带头人后备人选。长期从事早产儿临床与科研相关工作。任中国医学救援协会儿科救援分会副会长，中国人民解放军儿科学专委会主任委员，中国医师协会新生儿科分会副会长，中华医学会儿科学分会委员、新生儿学组副组长、灾害儿科学组名誉组长。长期致力于极/超早产儿相关疾病的研究，先后组织多项探索改善极/超早产儿预后新技术的多中心随机对照研究。主持国家重点研发计划，国家自然科学基金等项目10余项，研究成果以第一作者或通信作者发表于JAMA Pediatrics、Advanced Science、Lancet Infectious Disease、Lancet Child and Adolescent Health、Chest等SCI收录期刊共60余篇，单篇最高影响因子24.446，单篇最多引用1161次。执笔制定了灾害背景下NICU的应急准备方案(2017版)、“新生儿急性呼吸窘迫综合征”蒙特勒标准指南(2017版)、早产儿经鼻间歇正压通气临床应用指南(2019版)、中国新生儿肺表面活性物质临床应用专家共识(2021版)。两次荣立个人三等功。以第一责任人获得省部级科技成果二等奖2项、三等奖2项。

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刘立婷，博士研究生，主治医师，主要从事新生儿感染、新生儿急性呼吸窘迫综合征等方面的研究

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刘立婷，博士研究生，主治医师，主要从事新生儿感染、新生儿急性呼吸窘迫综合征等方面的研究

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史源，主任医师，教授，博士研究生导师。重庆医科大学附属儿童医院新生儿诊疗中心主任，国家重点研发计划首席专家，国家临床重点专科带头人，荣获首批“重庆英才创新领军人才”称号，重庆市学术技术带头人后备人选。长期从事早产儿临床与科研相关工作。任中国医学救援协会儿科救援分会副会长，中国人民解放军儿科学专委会主任委员，中国医师协会新生儿科分会副会长，中华医学会儿科学分会委员、新生儿学组副组长、灾害儿科学组名誉组长。长期致力于极/超早产儿相关疾病的研究，先后组织多项探索改善极/超早产儿预后新技术的多中心随机对照研究。主持国家重点研发计划，国家自然科学基金等项目10余项，研究成果以第一作者或通信作者发表于JAMA Pediatrics、Advanced Science、Lancet Infectious Disease、Lancet Child and Adolescent Health、Chest等SCI收录期刊共60余篇，单篇最高影响因子24.446，单篇最多引用1161次。执笔制定了灾害背景下NICU的应急准备方案(2017版)、“新生儿急性呼吸窘迫综合征”蒙特勒标准指南(2017版)、早产儿经鼻间歇正压通气临床应用指南(2019版)、中国新生儿肺表面活性物质临床应用专家共识(2021版)。两次荣立个人三等功。以第一责任人获得省部级科技成果二等奖2项、三等奖2项。

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史源，主任医师，教授，博士研究生导师。重庆医科大学附属儿童医院新生儿诊疗中心主任，国家重点研发计划首席专家，国家临床重点专科带头人，荣获首批“重庆英才创新领军人才”称号，重庆市学术技术带头人后备人选。长期从事早产儿临床与科研相关工作。任中国医学救援协会儿科救援分会副会长，中国人民解放军儿科学专委会主任委员，中国医师协会新生儿科分会副会长，中华医学会儿科学分会委员、新生儿学组副组长、灾害儿科学组名誉组长。长期致力于极/超早产儿相关疾病的研究，先后组织多项探索改善极/超早产儿预后新技术的多中心随机对照研究。主持国家重点研发计划，国家自然科学基金等项目10余项，研究成果以第一作者或通信作者发表于JAMA Pediatrics、Advanced Science、Lancet Infectious Disease、Lancet Child and Adolescent Health、Chest等SCI收录期刊共60余篇，单篇最高影响因子24.446，单篇最多引用1161次。执笔制定了灾害背景下NICU的应急准备方案(2017版)、“新生儿急性呼吸窘迫综合征”蒙特勒标准指南(2017版)、早产儿经鼻间歇正压通气临床应用指南(2019版)、中国新生儿肺表面活性物质临床应用专家共识(2021版)。两次荣立个人三等功。以第一责任人获得省部级科技成果二等奖2项、三等奖2项。

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Acta Med Okayama, 2022, 76(6): 635-643., articleTitle=MiR-338-3p is a biomarker in neonatal acute respiratory distress syndrome (ARDS) and has roles in the inflammatory response of ARDS cell models, refAbstract=null)], funds=[Fund(id=1199335053772816468, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199335049771450377, awardId=2022YFC2704803, language=EN, fundingSource=National Key Research and Development Program of China(2022YFC2704803), fundOrder=null, country=null), Fund(id=1199335053856702552, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199335049771450377, awardId=2022YFC2704803, language=CN, fundingSource=国家重点研发计划(2022YFC2704803), fundOrder=null, country=null)], companyList=[AuthorCompany(id=1199335051923128341, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199335049771450377, xref=null, ext=[AuthorCompanyExt(id=1199335051927322646, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199335049771450377, companyId=1199335051923128341, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=Department of Neonatology, Children's Hospital of Chongqing Medical University/National Clinical Research Center for Child Health and Disorders/Ministry of Education Key Laboratory of Child Development and Disorders/Chongqing Key Laboratory of Child Infection and Immunity, Chongqing 400015, China), AuthorCompanyExt(id=1199335051935711255, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199335049771450377, companyId=1199335051923128341, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=重庆医科大学附属儿童医院新生儿科/国家儿童健康与疾病临床医学研究中心/儿童发育疾病研究教育部重点实验室/儿童感染免疫重庆市重点实验室，重庆 400015)])], figs=[ArticleFig(id=1199335053214974008, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199335049771450377, language=EN, label=Fig.1, caption=Pathophysiological mechanism of neonatal ARDS, figureFileSmall=J8FuXe2PWQSx/6gW7MIJwg==, figureFileBig=LJR9RKSl9FGz001N/IK1Qw==, tableContent=null), ArticleFig(id=1199335053315637309, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199335049771450377, language=CN, label=图1, caption=新生儿ARDS的病理生理机制

ARDS. 急性呼吸窘迫综合征；直接损伤因素：严重肺部感染、肺出血、胎粪吸入综合征、血性羊水吸入、呛奶、溺水、有毒气体吸入和肺部挫伤等；间接损伤因素：败血症、坏死性小肠结肠炎、窒息、寒冷损伤、脑损伤、创伤和心脏手术等

, figureFileSmall=J8FuXe2PWQSx/6gW7MIJwg==, figureFileBig=LJR9RKSl9FGz001N/IK1Qw==, tableContent=null), ArticleFig(id=1199335053550518346, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199335049771450377, language=EN, label=Tab.1, caption=

The main differences among the Montreux, Berlin, and PALICC-2 definitions

, figureFileSmall=null, figureFileBig=null, tableContent=
参数蒙特勒标准柏林标准PALICC-2标准
发病年龄

早产儿：出生至纠正胎龄44周
足月儿：出生至生后4周

未提及，主要用于成人除外围产期的儿童
胸部影像学双侧浸润影双侧浸润影单侧或双侧浸润影
可否合并先天性心脏病可以(需注意氧合恶化不能用心脏疾病解释)否可以(需注意氧合恶化不能用心脏疾病解释)
分度指标OIPaO2/FiO2

有创机械通气：OI或OSI
无创通气：PaO2/FiO2或SpO2/FiO2

轻度无创或有创均适用，4.0≤OI<8.0200 mmHg<PaO2/FiO2≤300 mmHg，且PEEP或CPAP≥5cm H2O

有创通气时，4.0≤OI<16.0或5.0≤OSI<12.0

无创通气时，100<PaO2/FiO2≤300或150<SpO2/FiO2≤250

中度无创或有创均适用，8.0≤OI<16.0100 mmHg<PaO2/FiO2≤200 mmHg，且PEEP≥5cm H2O
重度无创或有创均适用，OI≥16.0PaO2/FiO2≤100 mmHg，且PEEP≥5cm H2O

有创通气时，OI≥16.0或OSI≥12.0

无创通气时，PaO2/FiO2≤100或SpO2/FiO2≤150

), ArticleFig(id=1199335053638598736, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1199335049771450377, language=CN, label=表1, caption=

蒙特勒标准、柏林标准及PALICC-2标准的主要区别

, figureFileSmall=null, figureFileBig=null, tableContent=
参数蒙特勒标准柏林标准PALICC-2标准
发病年龄

早产儿：出生至纠正胎龄44周
足月儿：出生至生后4周

未提及，主要用于成人除外围产期的儿童
胸部影像学双侧浸润影双侧浸润影单侧或双侧浸润影
可否合并先天性心脏病可以(需注意氧合恶化不能用心脏疾病解释)否可以(需注意氧合恶化不能用心脏疾病解释)
分度指标OIPaO2/FiO2

有创机械通气：OI或OSI
无创通气：PaO2/FiO2或SpO2/FiO2

轻度无创或有创均适用，4.0≤OI<8.0200 mmHg<PaO2/FiO2≤300 mmHg，且PEEP或CPAP≥5cm H2O

有创通气时，4.0≤OI<16.0或5.0≤OSI<12.0

无创通气时，100<PaO2/FiO2≤300或150<SpO2/FiO2≤250

中度无创或有创均适用，8.0≤OI<16.0100 mmHg<PaO2/FiO2≤200 mmHg，且PEEP≥5cm H2O
重度无创或有创均适用，OI≥16.0PaO2/FiO2≤100 mmHg，且PEEP≥5cm H2O

有创通气时，OI≥16.0或OSI≥12.0

无创通气时，PaO2/FiO2≤100或SpO2/FiO2≤150

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新生儿急性呼吸窘迫综合征诊断标准的演变及思考
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刘立婷 , 史源 *
解放军医学杂志 | 新生儿ARDS诊断与治疗专题 2024,49(3): 245-251
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解放军医学杂志 | 新生儿ARDS诊断与治疗专题 2024, 49(3): 245-251
新生儿急性呼吸窘迫综合征诊断标准的演变及思考
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刘立婷, 史源*
作者信息
  • 重庆医科大学附属儿童医院新生儿科/国家儿童健康与疾病临床医学研究中心/儿童发育疾病研究教育部重点实验室/儿童感染免疫重庆市重点实验室，重庆 400015

    • 刘立婷，博士研究生，主治医师，主要从事新生儿感染、新生儿急性呼吸窘迫综合征等方面的研究

    史源，主任医师，教授，博士研究生导师。重庆医科大学附属儿童医院新生儿诊疗中心主任，国家重点研发计划首席专家，国家临床重点专科带头人，荣获首批“重庆英才创新领军人才”称号，重庆市学术技术带头人后备人选。长期从事早产儿临床与科研相关工作。任中国医学救援协会儿科救援分会副会长，中国人民解放军儿科学专委会主任委员，中国医师协会新生儿科分会副会长，中华医学会儿科学分会委员、新生儿学组副组长、灾害儿科学组名誉组长。长期致力于极/超早产儿相关疾病的研究，先后组织多项探索改善极/超早产儿预后新技术的多中心随机对照研究。主持国家重点研发计划，国家自然科学基金等项目10余项，研究成果以第一作者或通信作者发表于JAMA Pediatrics、Advanced Science、Lancet Infectious Disease、Lancet Child and Adolescent Health、Chest等SCI收录期刊共60余篇，单篇最高影响因子24.446，单篇最多引用1161次。执笔制定了灾害背景下NICU的应急准备方案(2017版)、“新生儿急性呼吸窘迫综合征”蒙特勒标准指南(2017版)、早产儿经鼻间歇正压通气临床应用指南(2019版)、中国新生儿肺表面活性物质临床应用专家共识(2021版)。两次荣立个人三等功。以第一责任人获得省部级科技成果二等奖2项、三等奖2项。

通讯作者:

史源，E-mail：
Evolution and considerations of diagnostic criteria for neonatal acute respiratory distress syndrome
Li-Ting Liu, Yuan Shi*
Affiliations
  • Department of Neonatology, Children's Hospital of Chongqing Medical University/National Clinical Research Center for Child Health and Disorders/Ministry of Education Key Laboratory of Child Development and Disorders/Chongqing Key Laboratory of Child Infection and Immunity, Chongqing 400015, China
出版时间: 2024-03-28 doi: 10.11855/j.issn.0577-7402.0467.2023.0717
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自1967年急性呼吸窘迫综合征(ARDS)首次被报道以来，其诊断及分级标准不断演变。近年来，新生儿ARDS越来越受到关注，然而其研究进展缓慢，部分原因是诊断标准仍存在争议。本文就2012年柏林标准、2017年蒙特勒标准和2023年第二届小儿急性肺损伤共识会议更新的儿童ARDS诊断标准(PALICC-2标准)在新生儿ARDS中的应用进行概述，比较3种诊断标准的异同，分析3种诊断标准应用于新生儿ARDS时其分级标准、触发因素、发病率、病死率、不良预后和治疗等的差异，并提出未来新生儿ARDS诊断标准的研究方向。

新生儿急性呼吸窘迫综合征  /  诊断标准  /  变迁

Since acute respiratory distress syndrome (ARDS) was firstly reported in 1967, the diagnostic criteria and classification standard have evolved continually. Neonatal ARDS has drawn increasing attention in recent years, while research on neonatal ARDS has proceeded slowly, partly because of ambiguity in the definitions and diagnostic criteria of neonatal ARDS. In this comment, we overview the application of the Berlin definition made in 2012, the Montreux definition made in 2017, and the definition of pediatric ARDS update by the Second Pediatric Acute Lung Injury Consensus Conference made in 2023 (PALICC-2 definition) in neonatal ARDS, then compare the similarities and differences among the three definitions. Finally, the differences in classification standard, triggers, morbidity, mortality, poor prognosis, and treatment among the three definitions for neonatal ARDS were analyzed, and the research directions in the future of the definition for neonatal ARDS were proposed.

neonatal acute respiratory distress syndrome  /  diagnostic criteria  /  changes
刘立婷, 史源. 新生儿急性呼吸窘迫综合征诊断标准的演变及思考. 解放军医学杂志, 2024 , 49 (3) : 245 -251 . DOI: 10.11855/j.issn.0577-7402.0467.2023.0717
Li-Ting Liu, Yuan Shi. Evolution and considerations of diagnostic criteria for neonatal acute respiratory distress syndrome[J]. Medical Journal of Chinese People’s Liberation Army, 2024 , 49 (3) : 245 -251 . DOI: 10.11855/j.issn.0577-7402.0467.2023.0717
正文
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急性呼吸窘迫综合征(acute respiratory distress syndrome，ARDS)为临床常见的呼吸系统危重症，是一种主要表现为持续性低氧血症、气促、发绀和肺顺应性降低的急性弥漫性炎症性肺部疾病[1-2]。新生儿ARDS引起的急性肺损伤(acute lung injure，ALI)的病理生理学改变与儿童、成人ARDS的弥漫性炎症和损伤机制相似，临床表现也类似，但因为其生理上的特殊性，新生儿ARDS与儿童、成人ARDS的病因、治疗及预后不尽相同。目前的研究表明，在新生儿重症监护室(neonatal intensive care unit，NICU)住院患儿中，新生儿ARDS的患病率为1%~5%，病死率则高达17%~24%[3-4]，存活者可能遗留严重的呼吸系统和神经系统功能障碍，严重损害其生活质量，给社会和家庭造成沉重的负担，因此新生儿科医师要加强对该病的关注和认识，以改善其不良预后。目前，成人和儿童ARDS的诊断标准基本得到了广泛认可[5]，但新生儿ARDS的诊断标准仍然存在争议，由于不同研究使用不同的新生儿ARDS诊断标准，结果间的异质性较大，从而导致新生儿ARDS的相关研究进展缓慢。本文对新生儿ARDS诊断标准的变迁进行概述及探讨，分析各诊断标准的适用性与利弊，对蒙特勒标准、柏林标准及2023年第二届小儿急性肺损伤共识会议(Second Pediatric Acute Lung Injury Consensus Conference，PALICC-2)标准在新生儿ARDS诊断中的应用进行比较，旨在探讨最契合新生儿生理特点的ARDS的诊断标准。
1 ARDS诊断标准的演变
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1967年，Ashbaugh等[2]首次报道了12例病因不同，但均以顽固性低氧血症为临床特征，X线胸片表现为弥散性肺浸润，肺顺应性及功能残气量降低，常规呼吸治疗效果欠佳，需要使用呼气末正压(positive end expiratory pressure，PEEP)来改善氧合的一组病例，被命名为“成人型呼吸窘迫综合征(adult respiratory distress syndrome)”，但并未给出明确的诊断及严重程度分级标准。直至1994年，美国欧洲共识会议(American European Consensus Conference，AECC)认识到该病不仅发生在成人，儿童也会出现类似的肺部病变，故将成人型呼吸窘迫综合征改名为急性呼吸窘迫综合征，并首次制定了ARDS的诊断标准，同时也引入了ALI的定义且被广泛应用于临床[6]。但该诊断标准也存在一定的局限性，包括发病时间缺乏明确的标准，氧合评估不精确，未提及触发因素，以及需要有创的肺毛细血管压力测定等[7]。基于上述缺点，2012年欧洲危重症协会成立了国际专家小组，进一步完善及拓展了ARDS的定义，并明确了ARDS的严重程度分级，该标准被称为柏林标准[8]。
但AECC和柏林标准均更适合成人ARDS，考虑到儿童与成人ARDS在危险因素、流行病学、并发症、治疗和预后等方面的差异[9]，小儿急性肺损伤共识会议(Pediatric Acute Lung Injury Consensus Conference，PALICC)于2015年召开，首次在国际上制订了儿童ARDS的诊断标准——PALICC标准[10-11]。随后大量关于儿童ARDS的认识[包括病理生理学、肺保护机制、新型通气模式(经鼻高流量)等方面]得到了更新，因此，2023年召开的第二届小儿急性肺损伤共识会议更新了儿童ARDS的标准——PALICC-2标准[12]。与PALICC标准相比，PALICC-2标准具有以下改进：(1)应在诊断至少4 h后对儿童ARDS进行严重程度分级，以提高严重程度分级的准确性；(2)可对无创机械通气患儿进行严重程度分级；(3)划分了“疑似ARDS患儿”组，以防遗漏ARDS患儿。尽管PALICC-2标准在儿童ARDS定义上有了重大进展，相较柏林标准更加适合于儿科临床实践，但未考虑足月儿及早产儿的年龄特点，且未包含围产期患儿。与成人、儿童相比，新生儿具有其独特的解剖生理特点，且病因方面的差异较大，独特的围产期触发因素(如围产期窒息、早发败血症等)也是引起新生儿ARDS的重要原因，此外，新生儿的诊断及治疗(如呼吸支持方式的特殊性等)与成人、儿童存在较大差异，因此，柏林标准及PALICC标准(包括2023年发布的PALICC-2标准)并不完全适用于新生儿ARDS的诊断。考虑到上述标准在新生儿ARDS诊断中的局限性，在欧洲儿童与新生儿重症监护协会及欧洲儿童研究协会的支持下，国际多中心协作组于2017年发布了新生儿ARDS的诊断标准——蒙特勒标准[13]，该标准涵盖了围产期内的新生儿，并使用氧指数(oxygenation index，OI)作为诊断和严重程度分级的标准。
蒙特勒标准阐明了新生儿呼吸系统独特的解剖结构及生理特点，如新生儿肺泡数量较成人及儿童少，胸壁顺应性更好，膈肌的结构也不相同，导致新生儿潮气量小、呼吸频率高，围产期新生儿尤其是早产儿更易发生感染，因此，新生儿ARDS的治疗及预后与成人、儿童ARDS存在一定差异[13]。但是，新生儿ARDS引起ALI的病理生理学过程与成人、儿童ARDS的弥漫性炎症和损伤机制相似，均是由于肺内或肺外疾病导致巨噬细胞等分泌磷脂酶A2，水解表面活性物质中的磷脂，产生游离脂肪酸及大量炎症介质，再进一步损伤表面活性物质，这种恶性循环可导致继发性肺表面活性物质功能障碍，是ARDS发生的关键机制[13]。新生儿ARDS的病理生理机制类似于成人和儿童ARDS，具体见图1。
与以往诊断标准的不同之处还在于，蒙特勒标准强调了新生儿ARDS的适用年龄，并包含了围产期，而围产期部分疾病(如严重肺部感染、肺出血、胎粪吸入综合征、血性羊水吸入、呛奶、早发型败血症、窒息等)引起的呼吸衰竭通常在组织病理学上表现为弥漫性肺泡损伤：肺间质及肺泡出血、水肿，炎性细胞浸润，肺泡萎缩及透明膜形成等，上述组织病理学表现与经典ARDS的病理表现相似[14-15]。因此，新生儿ARDS发生于围产期内存在一定合理性。
此外，值得注意的是，对于新生儿尤其是早产儿来说，围产期内发生的呼吸窘迫，应注意鉴别是新生儿呼吸窘迫综合征(neonatal respiratory distress syndrome，NRDS)还是ARDS。NRDS发病人群主要为早产儿，尤其是极早产儿，为生后即刻或生后数小时内出现的进行性呼吸困难，胎龄越小、体重越轻则发病率越高，根本病因为肺发育不成熟导致肺表面活性物质的合成分泌不足，没有或仅存在较轻微的肺泡受损及肺血管和炎性细胞浸润，通常未合并其他器官功能障碍，积极的肺复张治疗联合外源性肺表面活性物质替代治疗效果较好，生后3 d病情可逐渐缓解[16]。而ARDS好发人群可能为早产儿，也可为足月儿，发病年龄也不确定，可由多种围产期触发因素(如胎粪吸入综合征、新生儿早发败血症、感染性肺炎、肺出血或围产期窒息)引起肺泡毛细血管壁弥漫性损伤，从而导致肺泡受损，或以肺血管、肺间质损伤和炎性细胞浸润为主的肺损伤，常合并其他器官功能异常，肺表面活性物质治疗后有一定好转，但一般需多次使用且剂量偏大，生后3 d病情缓解不明显。因此，当患儿出现呼吸窘迫且对肺复张及肺表面活性物质治疗反应欠佳时，新生儿科临床医师应考虑患儿存在新生儿ARDS而非NRDS。
新生儿ARDS的蒙特勒标准是对既往已发表的ARDS相关文献进行分析、总结和测试后形成的专家共识，建立时间较短，其能否在临床实践中广泛应用，还需要不断评估与验证。目前，已有少数临床研究采用AECC标准、柏林标准及PALICC标准比较儿童ARDS的患病率及预后，进而评估何种标准更适合诊断儿童ARDS[17-19]。而针对新生儿ARDS，蒙特勒标准、PALICC-2标准和柏林标准中哪一种更有利于临床诊疗，能更好地区分出重症患儿，更准确地预测患儿的预后，是目前诊疗的关键问题，但相关研究很少，尚需深入探讨。蒙特勒标准、柏林标准及PALICC-2标准的主要区别见表1。
2 蒙特勒标准与柏林标准的对比探讨
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蒙特勒和柏林标准用于诊断新生儿ARDS最主要的区别在于诊断及严重程度分级的指标不同。柏林标准使用氧合指数(PaO2/FiO2)作为ARDS的诊断和分级指标，但PaO2/FiO2容易受PEEP的影响，例如，在PaO2/FiO2相同的新生儿ARDS中，PEEP高的患儿肺损伤较PEEP低的患儿更严重[20]，且目前越来越多的新生儿使用高频振荡通气，无法有效获取PEEP值。因此，以PaO2/FiO2作为新生儿ARDS定义和分级的指标存在一定的局限性。与柏林标准不同，无论使用有创还是无创通气，蒙特勒标准均使用OI作为新生儿ARDS诊断及严重程度分级的指标，在计算OI时加入平均气道压(mean airway pressure，MAP)，可更客观地评估PEEP对氧合的影响[21-22]。研究发现，在评估成人和儿童ARDS病死率和并发症方面，OI通常优于PaO2/FiO2[23-25]，这与目前在新生儿ARDS中的研究结果一致。
一项回顾性研究发现，应用蒙特勒标准和柏林标准定义的新生儿ARDS在NICU中的患病率分别为3.1%及3.3%，病死率分别为18.9%及18.0%，差异无统计学意义；从严重程度分级来看，蒙特勒标准重度组中接受一氧化氮治疗的患儿比例高于柏林标准重度组患儿，而呼吸机使用时间、NICU住院时间、并发症发生率和抗生素使用方面两组均无统计学差异[26]。此外，该研究还发现，约有12%的新生儿ARDS既符合蒙特勒标准中度又符合柏林标准重度，这些患儿的不良预后(如病死率、并发症等)与同时符合两种标准的中度ARDS的患儿相似，提示蒙特勒标准较柏林标准在严重程度分级及预后预测方面更准确。
3 蒙特勒标准与PALICC-2标准的对比探讨
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蒙特勒标准与PALICC-2标准的区别主要在于以下几点：(1)PALICC-2标准与PALICC标准一样除外了围产期ARDS的表现，而蒙特勒标准可包括此阶段；(2)蒙特勒标准要求存在双肺浸润，而PALICC-2标准不要求；(3)无论患儿采用有创还是无创通气，蒙特勒标准均使用OI而不是氧合饱和度指数(oxygenation saturation index，OSI)来诊断新生儿ARDS，并对其严重程度进行分级。
重庆医科大学附属儿童医院一项待发表的回顾性数据分析显示，因PALICC-2标准除外了围产期的患儿，故应用蒙特勒标准与PALICC-2标准定义的新生儿ARDS在NICU中的患病率差异有统计学意义(3.4% vs. 0.9%)。该研究将符合蒙特勒标准围产期外的新生儿ARDS与符合PALICC-2标准的新生儿ARDS进行比较发现，两组轻/中度、重度患儿例数相比差异无统计学意义，且两组在病死率、并发症及治疗方面差异也无统计学意义，提示对于两种标准均适用的人群，二者的严重程度分级标准差异不大。此外，该研究中符合蒙特勒标准的ARDS患儿围产期内、外两组间的基本特征和触发因素不一致，且病死率、并发症、出院后家庭氧疗等结局方面差异也较大；与围产期外组比较，围产期组的病死率、支气管肺发育不良(bronchopulmonary dysplasia，BPD)、继发性败血症和早产儿视网膜病(retinopathy of prematurity，ROP)的发生率降低，而气漏综合征和新生儿持续性肺动脉高压(persistent pulmonary hypertension of the newborn，PPHN)的发生率明显增高，抗生素使用时间、呼吸机使用时间、NICU住院时间及出院后家庭氧疗时间明显缩短，差异均有统计学意义(P<0.05)，提示围产期内外新生儿ARDS的治疗、预后存在一定差异。
目前关于两种标准最大的争议为新生儿ARDS是否包含围产期。已有多个研究报道，新生儿ARDS包括早产儿因围产期疾病导致的ARDS具备成人ARDS的所有临床表现，但未达到PALICC标准的定义[27-29]；且如前所述，围产期触发因素导致的ALI的病理生理机制及组织病理学表现与成人和儿童ARDS相似，也支持新生儿ARDS可能存在于围产期的观点。而围产期内ARDS患儿相比其他年龄段患儿在触发因素、病死率、不良预后及治疗方面均表现出独特的特点，可能与出生后肺形态变化、免疫发育、持续的胎儿循环及围产期肺血管阻力变化等围产期生理的特殊性有关[30]。这种情况类似于儿童和成人ARDS在触发因素、患病率、病死率和预后方面也存在着较大差异[31-32]，提示虽然围产期新生儿可能是一个特殊的群体，但不应将其排除在新生儿ARDS的标准之外。因此，笔者认为PALICC-2标准在新生儿ARDS的发病年龄定义方面存在一定局限性。此外，根据PALICC-2标准，在接受无创机械通气或经鼻高流量治疗的患儿中，使用PaO2/FiO2或SpO2/FiO2诊断新生儿ARDS并进行严重程度分级，而在接受有创机械通气治疗的患儿中则使用OI或OSI(在动脉血气无法获取时)来诊断新生儿ARDS及进行分度。PaO2/FiO2作为新生儿ARDS定义和分级的指标具有一定的局限性，而SpO2/FiO2和OSI受胎儿血红蛋白水平的影响，在新生儿期内，不同患儿不同阶段体内的胎儿血红蛋白含量波动较大，且新生儿时期频繁的输血治疗，以及目标脉搏血氧饱和度(SpO2)的不确定性[33]，均可能影响SpO2/FiO2及OSI评估ARDS严重程度的准确性。而无论患儿采用有创还是无创通气，蒙特勒标准均使用OI诊断新生儿ARDS及进行严重程度分级，较PALICC-2标准更简便，也不受胎儿血红蛋白变化的影响，可用于评估接受无创及有创机械通气的新生儿ARDS患儿的预后。
4 总结与展望
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目前已有少数临床研究采用不同的诊断标准比较成人或儿童ARDS的患病率、并发症及病死率等，以探讨何种标准更适合诊断ARDS。2014年Bordes等[17]报道，对于烧伤患者发生的ARDS，柏林标准较AECC标准更能准确评估其严重程度。而2019年Kogan等[18]对3946例心脏手术后的ARDS患者分别应用柏林标准及AECC标准进行比较，发现两种标准下的ARDS患病率、病死率及危险因素差异无统计学意义。此外，2017年Parvathaneni等[19]比较了3种不同的ARDS诊断标准(PALICC标准、柏林标准及AECC标准)下儿童ARDS发病率及病死率的差异，发现PALICC标准下ARDS发病率较高、病死率较低，且被分类为重度的ARDS患儿病死率较高，提示PALICC标准可更好地预测ARDS患儿的不良预后。
关于新生儿ARDS的诊断标准，目前大部分研究集中于其与新生儿NRDS的鉴别，除应用蒙特勒标准与柏林标准对新生儿ARDS进行比较这一回顾性研究[26]外，较少关于新生儿ARDS不同诊断标准对比的报道。ARDS不同诊断标准的侧重点不同，柏林标准侧重于成人，PALICC-2标准主要用于儿童，因而用于诊断新生儿ARDS存在部分局限性，尤其是除外了围产期这部分重要人群。蒙特勒标准则是国际性多中心多学科协作组为新生儿制定的ARDS标准，既考虑到与成人和儿童ARDS诊断标准的接轨，又体现了新生儿的特点。对于围产期外的新生儿，蒙特勒标准与PALICC-2标准及柏林标准的诊断及严重程度划分差异不大，分歧较小。围产期内的新生儿是否纳入ARDS诊断争议较大，但结合围产期独特的触发因素，与其他年龄段ARDS类似的肺损伤病理生理过程及组织病理学表现，笔者认为，绝大部分足月与近足月围产期新生儿ARDS的诊断是明确的；部分极早产儿和超早产儿可能存在NRDS合并ARDS，对于这此患儿如何准确诊断及分度是未来新生儿ARDS诊断标准需探讨的一个方向。
蒙特勒标准问世以来，有不少研究已采用该标准在新生儿ARDS领域开展了高水平的临床研究[26,34-35]，但其提出时间较短，与柏林标准及PALICC-2标准相比，到底哪种标准更适合新生儿ARDS的诊断和严重程度分级，以及更有效地预测新生儿ARDS的预后，尚需要开展更多高质量的多中心、前瞻性临床研究进行比较。此外，找出能够增加新生儿ARDS诊断敏感度、特异度及准确划分严重程度的生物标志物，是目前新生儿ARDS的研究热点，下一步可在临床研究的基础上结合特异性生物标志物来进行疾病诊断及分级标准的探讨[36]，以评估新生儿ARDS不同诊断标准的效能，建立更客观、更能准确预测新生儿ARDS远期预后的诊断和分级标准。未来，新生儿及儿童重症医学专家尚需在高质量研究的基础上，统一新生儿ARDS的诊断及分度标准，减少诊断标准不一致给临床实践与科学研究造成的困扰。
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  • 国家重点研发计划(2022YFC2704803)
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doi: 10.11855/j.issn.0577-7402.0467.2023.0717
  • 接收时间：2023-03-30
  • 首发时间：2025-11-23
  • 出版时间：2024-03-28
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  • 收稿日期：2023-03-30
  • 录用日期：2023-07-11
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National Key Research and Development Program of China(2022YFC2704803)
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    重庆医科大学附属儿童医院新生儿科/国家儿童健康与疾病临床医学研究中心/儿童发育疾病研究教育部重点实验室/儿童感染免疫重庆市重点实验室，重庆 400015

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