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中国循证儿科杂志

中国循证儿科杂志 ›› 2020, Vol. 15 ›› Issue (5): 325-333.

• 论著 • 上一篇    下一篇

应用脉搏血氧饱和度或/和临床评估（心脏杂音听诊）筛查新生儿危重型先天性心脏病的系统评价和Meta分析

胡晓静1,2，马晓静1,3，曾子倩3，赵峥山3，王定美3，陈红燕4，王瑞5，张崇凡5，黄国英1,3,6   

  1. 复旦大学附属儿科医院 上海，201102：1 新生儿先心病筛查国家级项目管理办公室，2 护理部，3 心血管中心，4 临床流行病学办公室，5 临床指南制作和评价中心，6 上海市出生缺陷重点实验室
  • 收稿日期:2020-10-14 修回日期:2020-10-14 出版日期:2020-10-25 发布日期:2020-10-25
  • 通讯作者: 黄国英；张崇凡
  • 基金资助:
     

Pulse oximetry or/and clinical assessment (cardiac murmur auscultation) in screening for critical congenital heart disease in the early neonatal stage: A systematic review and meta-analysis

HU Xiaojing1,2, MA Xiaojing1,3, ZENG Ziqian3, ZHAO Zhengshan3, WANG Dingmei3, CHEN Hongyan4, WANG Rui5, ZHANG Chongfan5, HUANG Guoying1,3,6   

  1. Children's Hospital of Fudan University,  Shanghai 201102, China;1 National Project Management Office of Neonatal Congenital Heart Disease Screening; 2 Nursing Department; 3 Pediatric Heart Center; 4 Clinical Epidemiology Office; 5 Clinical Practice Guideline Development and Evaluation Center; 6 Shanghai Key Laboratory of Birth Defects
  • Received:2020-10-14 Revised:2020-10-14 Online:2020-10-25 Published:2020-10-25
  • Contact: HUANG Guoying；ZHANG Chongfan
  • Supported by:
     

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摘要： 目的：评估各种先天性心脏病（CHD）筛查方案早期发现新生儿危重型CHD（CCHD）的准确性和假阳性率。方法：本文文献检索和筛选是在新生儿CCHD筛查（NCCHDS）指南中实现的。以筛查阳性婴儿行心脏超声检查确诊为CCHD，或随访出现CHD症状和体征后以心脏超声或以手术或心脏导管介入术证实为CCHD为金标准。以QUADAS-2 量表对纳入文献行偏倚风险及临床适用性评价，提取文献数据，汇总敏感度、特异度、假阳性率和AUC等诊断参数。结果：21篇文献进入本文Meta分析，共有3种不同方案筛查新生儿CCHD ：单纯脉搏血氧饱和度（POX） 21篇、POX+临床评估（CE）3篇、POX+心脏杂音听诊（MUR）2篇。样本量435~167 190例，研究来自美国7篇，欧洲9篇，亚洲4篇，非洲1篇；单纯POX、POX+CE和POX+MUR筛查敏感度分别为72.2%（95%CI：60.4%~81.6%）、91.0%（95%CI：86.3%~94.2%）和93.7%（95%CI：89.2%~96.4%），特异度分别为99.8%（95%CI：99.7%~99.9%）、98.5%（95%CI：96.7%~99.3%）和98.3%（95%CI：97.2%~99.0%），AUC分别为0.973、0.964和0.982。单纯POX筛查行亚组分析显示，以校正后P＜0.01为标准，不同亚组敏感度差异均无统计学意义；重复测量较单次测量亚组假阳性率差异有统计学意义。POX筛查新生儿CCHD敏感度和特异度异质性与筛查者是否经过培训、不同等级医院筛查、筛查仪的核心技术不同和反复或一次性探头的种类有关。结论：单纯POX、POX+CE和POX+MUR方案筛查新生儿CCHD的AUC差别不大；接受筛查中等敏感度时，可选择单纯POX筛查；接受筛查高敏感度时，可选择POX+CE和POX+MUR，更优化筛查指标可选择POX+MUR。

 

Abstract: Objective: To evaluate the accuracy and false positive rate of congenital heart disease (CHD) screening protocols for early detection of critical CHD (CCHD) in neonates. Methods: Literature search and selection were carried out during the development of the neonatal CCHD screening (NCCHDS) guideline. The reference standard for the diagnosis of CCHD was echocardiography, or through signs and symptoms of neonates during follow-up with confirmation of CCHD by echocardiography, surgery, or cardiac catheterization. The risk of bias and clinical applicability of the included literature were evaluated with the QUADAS-2 scale. Data were extracted and diagnostic parameters including sensitivity and specificity were summarized with the random effect model. Results: Twenty-one articles were included in this meta-analysis, and three different protocols were reported for screening neonatal CCHD: pulse oximetry alone (POX; n=21)，POX+clinical evaluation (CE) (n=3), POX+murmur (MUR) (n=2). The sample size of the included studies ranged from 435 to 167,190. There were 7 studies from the United States, 9 from Europe, 4 from Asia, and 1 from Africa. The sensitivity and specificity of POX alone, POX+CE and POX+MUR screening were 72.2%（95%CI: 60.4%-81.6%）, 91.0%（95%CI: 86.3%-94.2%）and 93.7%（95%CI: 89.2%-96.4%）, respectively and 99.8%（95%CI: 99.7%-99.9%）, 98.5%（95%CI: 96.7%-99.3%）and 98.3%（95%CI: 97.2%-99.0%）, respectively. The AUC was 0.973, 0.964 and 0.982, respectively. Subgroup analysis of POX screening alone showed there were no statistically significant differences in sensitivity across all subgroups (P＜0.01 after correction) and repeated measurement had higher false positive rates compared with single measurement. Heterogeneity of sensitivity and specificity of POX screening for neonatal CCHD was possibly related to whether the screener has been trained, level of hospital, different core technical aspects of screening instruments, and use of reusable or disposable probes or different probe types. Conclusion: The differences among AUC of POX alone, POX+CE, POX+MUR are small. POX alone is available for the moderate sensitivity of screening. POX+CE and POX+MUR are recommended for the higher sensitivity of screening and POX+MUR is recommended for optimizing screening indicators.

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