在中国,采用脉搏血氧测定法结合临床评估对主要先天性心脏病的筛查是可行和可靠的。这种简单、准确的联合方法可以在医院产科应用于对先天性心脏病进行筛查。

—2014年8月30日《柳叶刀》


中文翻译


 

题目

脉搏血氧测定法结合临床评估筛查中国新生儿的先天性心脏病:一项前瞻性的研究。

译文

背景:一些前期的研究已经为广泛使用脉搏血氧测定来筛查危重先天性心脏病提供了证据。但是,尚不清楚这些来自高收入国家的研究所报道的筛查的益处,是否在低收入国家也能取得类似的成功。因此,我们评价了在中国应用脉搏血氧测定结合临床评估,来筛查主要的先天性心脏病,尤其是危重先天性心脏病的可行性和可靠性。

方法:我们先在上海的三家医院开展了一个初步的研究,对脉搏血氧测定法结合临床评估筛查先天性心脏病的准确度进行评价。我们在招募研究对象之前做了数据收集的计划。然后我们开展了一个大规模、前瞻性、多中心的筛查研究,对在 2011年8 月1日至 2012年 11月30日期间在中国18家医院出生的全部新生儿(年龄6-72小时)进行了筛查。出现阳性结果的新生儿(异常脉搏血氧或异常的临床评估)在24小时内采用超声心动图进行筛查。根据临床的随访和父母的反馈信息鉴定假阴性的结果。我们分别计算单独采用脉搏血氧测定法和脉搏血氧测定法结合临床评估筛查主要的和危重先天性心脏病的灵敏度、特异度、阳性和阴性预测值、阳性和阴性似然比。

发现:在初步研究中,共筛查了6785名新生儿;脉搏血氧测定法结合临床评估发现49例无症状的主要先天性心脏病中的46例(94%),而八例无症状的危重先天性心脏病全都成功检测了出来(100%)。在前瞻性多中心的研究中,我们筛查了122 738名新生儿(120 707 名无症状;2031名有症状);筛查出1071名先天性心脏病(157名危重型和330名主要型)。在无症状新生儿中,脉搏血氧测定法结合临床评估对危重先天性心脏病的敏感度是93·2% (95% CI 87·9-96·2);而对主要先天性心脏病的敏感度是90·2% (86·4-93·0)。将脉搏血氧测定法加入临床评估使筛查先天性心脏病的敏感度从77·4% (95% CI 70·0-83·4)提高到93·2% (87·9-96·2)。单纯临床评估筛查危重先天性心脏病的假阳性率是2·7% (3298/120 392)而单纯脉搏血氧测定法是0·3% (394 /120 561)。

说明:在中国,采用脉搏血氧测定法结合临床评估对主要先天性心脏病的筛查是可行和可靠的。这种简单、准确的联合方法可以在医院产科应用于对先天性心脏病进行筛查。

英文原稿


 

[Title]

Pulse oximetry with clinical assessment to screen for congenital heart disease in neonates in China:

a prospective study

[Authors]

Qu-ming Zhao, Xiao-jing Ma, Xiao-ling Ge, Prof Fang Liu, Wei-li Yan, Lin Wu, Ming Ye, Xue-cun Liang, Jing Zhang, Yan Gao, Prof Bing Jia, Guo-ying Huang

[Abstract]

Background: Several pioneering studies have provided evidence for the introduction of universal pulse oximetry screening for
critical congenital heart disease. However, whether the benefits of screening reported in studies from high-income countries
would translate with similar success to low-income countries is unknown. We assessed the feasibility and reliability of pulse
oximetry plus clinical assessment for detection of major congenital heart disease, especially critical congenital heart disease,
in China.

Methods: We did a pilot study at three hospitals in Shanghai to assess the accuracy of pulse oximetry plus clinical assessment
for detection of congenital heart disease. We made a data collection plan before recruitment. We then undertook a large,
prospective, and multicentre screening study in which we screened all consecutive newborn babies (aged 6—72 h) born at
18 hospitals in China between Aug 1, 2011, and Nov 30, 2012. Newborn babies with positive screen results (either an abnormal
pulse oximetry or abnormal clinical assessment) were referred for echocardiography within 24 h of screening. We identified false-
negative results by clinical follow-up and parents’ feedback. We calculated sensitivity, specificity, positive and negative predictive
values, and positive and negative likelihood ratios for pulse oximetry alone, and in combination with clinical assessment, for detection
of major and critical congenital heart disease.

Findings: In the pilot study, 6785 consecutive newborn babies were screened; 46 of 49 (94%) cases of asymptomatic major
congenital heart disease and eight of eight (100%) cases of asymptomatic critical disease were detected by pulse oximetry
and clinical assessment. In the prospective multicentre study, we screened 122 738 consecutive newborn babies (120 707
asymptomatic and 2031 symptomatic), and detected congenital heart disease in 1071 (157 critical and 330 major). In
asymptomatic newborn babies, the sensitivity of pulse oximetry plus clinical assessment was 93·2% (95% CI 87·9—96·2)
for critical congenital heart disease and 90·2% (86·4—93·0) for major disease. The addition of pulse oximetry to clinical
assessment improved sensitivity for detection of critical congenital heart disease from 77·4% (95% CI 70·0—83·4) to
93·2% (87·9—96·2). The false-positive rate for detection of critical disease was 2·7% (3298 of 120 392) for clinical
assessment alone and 0·3% (394 of 120 561) for pulse oximetry alone.

Interpretation: Pulse oximetry plus clinical assessment is feasible and reliable for the detection of major congenital heart
disease in newborn babies in China. This simple and accurate combined method should be used in maternity hospitals
to screen for congenital heart disease.

原文地址

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)60198-7/abstract

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