非海平面地区使用脉搏血氧饱和度筛查新生儿先天性心脏病的系统评价和Meta分析  

Screening for neonatal congenital heart disease using pulse oximetry in non-sea level areas:A systematic review and meta-analysis

作　　者：董瑶瑶 贾品[2,5] 田友平 裘梦凡 万凡 夏倩文 王源 胡晓静 黄国英 DONG Yaoyao;JIA Pin;TIAN Youping;QIU Mengfan;WAN Fan;XIA Qianwen;WANG Yuan;HU Xiaojing;HUANG Guoying(Children's Hospital of Fudan University,Department of Neonatology,Shanghai 201102,China;Children's Hospital of Fudan University,Office of Scientific Research,Shanghai 201102,China;Children's Hospital of Fudan University,Department of Nursing,Shanghai 201102,China;School of Nursing,Fudan University,Shanghai 200032,China;National Project Management Office of Neonatal Congenital Heart Disease Screening,Shanghai 201102,China;The First Affiliated Hospital of Zhejiang University School of Medicine,Hangzhou 310000,China;Shanghai Key Laboratory for Prevention and Control of Birth Defects,Shanghai 201102,China;Early Prevention and Control of Paediatric Genetically Related Cardiovascular Diseases Innovation Unit,Chinese Academy of Medical Sciences,Beijing 100730,China)

机构地区：[1]复旦大学附属儿科医院新生儿科,上海201102 [2]复旦大学附属儿科医院科研部,上海201102 [3]复旦大学附属儿科医院护理部,上海201102 [4]复旦大学护理学院,上海200032 [5]新生儿先心病筛查国家级项目管理办公室,上海201102 [6]浙江大学医学院附属第一医院,杭州310000 [7]上海市出生缺陷防治重点实验室,上海201102 [8]中国医学科学院小儿遗传相关心血管疾病早期防控创新单元,北京100730

出　　处：《中国循证儿科杂志》2025年第2期110-116,I0003-I0012,共17页Chinese Journal of Evidence Based Pediatrics

基　　金：国家重点研发计划项目:2021YFC2701004,2016YFC1000500;上海市申康医院发展中心项目:SHDC2022CRS005B;中国医学科学院医学与健康科技创新工程项目:2019-I2M-5-002;上海市科委技术标准项目:23DZ2203000,24DZ2202800。

摘　　要：初筛,阅读全文复筛。纳入在特定海拔地区(至少包括1个非海平面地区)进行的,研究对象为新生儿,采用POX筛查或POX结合其他方法筛查CHD,文中描述了具体筛查方案的文献。排除重复发表或无法获取全文,或文献类型为传统综述、会议等,或无诊断CHD的金标准,或无法提取诊断准确性参数或四格表数据的文献。提取纳入文献的基本情况、筛查信息和诊断参数等。采用QUADAS-2评价工具对纳入文献进行偏倚风险评价。采用R 4.4.0软件进行Meta分析。主要结局指标POX筛查非海平面地区新生儿CHD的诊断参数。结果纳入7项诊断准确性研究。样本量199~6109例。低质量文献1篇、中等质量文献4篇、高质量文献2篇。3项单中心研究,为非海平面地区,海拔806~3380 m;4篇多中心研究,包含海平面地区和非海平面地区,海拔≤610 m~4338 m。使用美国儿科学会规定的筛查方案(AAP筛查方案亚组)4篇,在AAP筛查方案的基础上调整SpO 2阈值或结合其他筛查手段(调整方案亚组)3篇。①非海平面地区AAP筛查方案亚组(2项研究,海拔分别为806 m和1646 m)Meta分析结果显示:敏感度66%(95%CI:14%~96%),特异度97%(95%CI:97%~98%),假阳性率3%(95%CI:2%~3%),AUC 0.79(95%CI:0.55~1.00);调整方案亚组(1项研究,海拔3380 m)Meta分析结果显示:敏感度74%(95%CI:65%~81%),特异度81%(95%CI:78%~84%),假阳性率19%(95%CI:16%~22%),AUC 77.4(95%CI:0.732~0.816)。②非海平面地区+海平面地区AAP筛查方案亚组(1项研究,海拔100~1900 m)Meta分析结果显示:筛查敏感度79%(95%CI:38%~96%),特异度99%(95%CI:99%~99%),假阳性率1%(95%CI:1%~1%),AUC 0.871(95%CI:0.711~1.00);调整方案亚组(2项研究,海拔≤610~4338 m)Meta分析结果显示:敏感度61%(95%CI:41%~79%),特异度96%(95%CI:96%~97%),假阳性率4%(95%CI:0~31%),AUC 0.80(95%CI:0.71~0.89)。1项研究未纳入Meta分析,通过概率图和95%CI的预测回归线显示,若使用AAP筛查方案,可能会导致海拔780 m处比�s were read for initial screening and the full text was read for re-screening.Included studies were neonates screened for CHD by POX screening or POX combined with other methods,specific screening protocols were described in the text,and studies were conducted in the literature at specific altitudes(including at least 1 non-sea level area).Literature that was duplicated or for which full text was not available,or for which the type of literature was a traditional review,conference,etc,or for which there was no gold standard for the diagnosis of CHD,or for which no diagnostic accuracy parameters or four-compartmental table data could be extracted,was excluded.Basic information,screening information and diagnostic parameters of the included literature were extracted.The QUADAS-2 evaluation tool was used to evaluate the risk of bias of the included literature.Meta-analysis was performed using R 4.4.0 software.Main outcome measures Diagnostic parameters of POX screening for neonatal CHD in non-sea-level areas.Results Seven diagnostic accuracy studies were included.Sample size 199-6,109 cases.One low quality,four medium quality,and two high quality studies.three single-centre studies,non-sea level areas,elevations 806-3,380 m,and four multi-centre studies,including sea level areas and non-sea level areas,elevations 0m to 4,338 m.Four studies using the AAP screening protocol(subgroup of the AAP screening protocol),with adjustments of SpO 2 thresholds on top of AAP screening protocols or combined with other screening tools(Adjustment Programme subgroup)3 articles.①Meta-analysis of the AAP screening programme subgroup in non-sea level areas(2 studies,806 m and 1,646 m above sea level)showed a sensitivity of 66%(95%CI:14%-96%),a specificity of 97%(95%CI:97%-98%),a false-positive rate of 3%(95%CI:2%-3%),an AUC of 0.79(95%CI:0.55-1.00);Meta-analysis of the adjusted protocol screening subgroup(1 study,3,380 m above sea level)showed a sensitivity of 74%(95%CI:65%-81%),a specificity of 81%(95%CI:78%-84%),a false-positive rat

关 键 词：新生儿 先天性心脏病 脉搏血氧饱和度 筛查 海拔 

分 类 号：R722.1[医药卫生—儿科]