Thangaratinam Shakila, Daniels Jane, Ewer Andrew K, Zamora Javier, Khan Khalid S
Academic Unit, Birmingham Women's Hospital, Birmingham, UK.
Arch Dis Child Fetal Neonatal Ed. 2007 May;92(3):F176-80. doi: 10.1136/adc.2006.107656. Epub 2007 Mar 7.
To evaluate the accuracy of pulse oximetry as a screening tool for congenital heart disease in asymptomatic newborns. DESIGN, DATA SOURCES AND METHODS: Systematic review of relevant studies identified through MEDLINE, EMBASE, Cochrane Library, MEDION, and bibliographies of retrieved primary and review articles. Two reviewers independently extracted data on study characteristics, quality and results to construct 2x2 tables with congenital heart disease as the reference standard. A random-effects bivariate model was used to meta-analyse estimates of sensitivity and specificity. Logit pairs of sensitivity and specificity of each study were analysed in a single model, accounting for their correlation due to differences in threshold between studies.
Eight studies were included with a total of 35 960 newborns. Pulse oximetry was performed on asymptomatic newborns in all studies; three studies excluding newborns with an antenatal diagnosis of congenital heart disease. Either functional or fractional oxygen saturation was measured by pulse oximetry with oxygen saturation below 95% as the cut-off level in most studies. On the basis of the eight studies, the summary estimates of sensitivity and specificity were 63% (95% CI 39% to 83%) and 99.8% (95% CI 99% to 100%), respectively, yielding a false positive rate of 0.2% (95% CI 0% to 1%).
Pulse oximetry was found to be highly specific tool with very low false positive rates to detect congenital heart disease. Large, well-conducted prospective studies are needed to assess its sensitivity with higher precision.
评估脉搏血氧饱和度测定法作为无症状新生儿先天性心脏病筛查工具的准确性。
设计、数据来源与方法:通过MEDLINE、EMBASE、Cochrane图书馆、MEDION以及检索到的原始文献和综述文章的参考文献,对相关研究进行系统评价。两名评价者独立提取有关研究特征、质量和结果的数据,以先天性心脏病为参考标准构建2×2列联表。采用随机效应双变量模型对敏感性和特异性估计值进行荟萃分析。在单一模型中分析每项研究的敏感性和特异性的对数对,考虑到由于研究间阈值差异导致的相关性。
纳入八项研究,共35960例新生儿。所有研究均对无症状新生儿进行了脉搏血氧饱和度测定;三项研究排除了产前诊断为先天性心脏病的新生儿。多数研究采用脉搏血氧饱和度测定法测量功能性或分数氧饱和度,以氧饱和度低于95%作为截断水平。基于这八项研究,敏感性和特异性的汇总估计值分别为63%(95%可信区间39%至83%)和99.8%(95%可信区间99%至100%),假阳性率为0.2%(95%可信区间0%至1%)。
发现脉搏血氧饱和度测定法是检测先天性心脏病的高度特异性工具,假阳性率极低。需要开展大规模、实施良好的前瞻性研究,以更精确地评估其敏感性。