新生儿听力筛查中的假阳性问题

False positives in newborn hearing screening

目的:探讨听力筛查假阳性的发生率和原因,以降低假阳性发生率。方法:2003年3月至2004年6月,用ERO-SCAN耳声发射仪(德国MAICO公司),采用快速自动筛查方法为50 271例新生儿行听力筛查,对听力筛查未通过者行ABR和耳科学检查,明确有无听力障碍及其程度。随访1年以上,分析135例未通过听力筛查的新生儿的听力学资料,按照假阳性新生儿占同期参加听力筛查的全部新生儿的比例,或按照假阳性新生儿占未通过听力筛查者的比例,分别计算听力筛查未通过患儿的假阳性率。结果:听力筛查50271例中,135例异常,ABR检查确诊31例有听力障碍,104例排除了听力障碍确定为假阳性。按照假阳性新生儿占同期参加听力筛查的全部新生儿的比例,听力筛查假阳性率为0.2%(104/50271);而按照假阳性新生儿占未通过听力筛查者的比例,听力筛查假阳性率为77.1%(104/135)。结论:随着听力筛查的广泛开展,听力筛查中遇到的问题也越来越多,虽然听力筛查中假阳性率很低,但其绝对数量不可忽视,特别是假阳性带来的一系列问题,如患儿家属的担心和害怕、增加患者的就诊次数和花费等,因此,应重视假阳性出现的原因,以合理的解释、处理和减少其发生率。

Objective： Congenital bilateral hearing impairment occurs in approximately 1 in every 1000 live births. Universal newborn hearing screening （UNHS） programs are the most effective method for early diagnosis. Our purpose is to investigate the rate and the reason of false positive in newbom hearing screening, and to find out the way to reduce the false positive and the following problems . Methods： From March 2003 to June 2004, there were 50 271 newborns tested by Ero- scan otoacoustic emissions （OAE） hearing screening. Babies who did not pass （who＇ refer＇ ）following their initial hearing screening were followed up and received routine audiologic evaluations with procedure of distortion product toacoustic emissions, diagnostic auditory brainstem response （ABR） test and ear physical examination for two or three times to determine whether the babies had hearing loss and its severity . After that, the rate of false positives was calculated by two methods： one was the percentage of total number of all screening infants （regardless of the outcome of stage one） who, at the end of the whole screening process were found to be hearing; the other way was reported as the percentage of infants who, having failed the first screening, were found to be hearing after retest. Results： A total of 135 babies out of 50 271 newboms was referred . Finally 31 babies of them were diagnosed with different degree of hearing loss, the other 104 babies were confirmed with normal hearing level. Calculated by the percentage of all the hearing screening babies, the false positive rate was 0.2 % （ 104/50 271 ） ; calculated by the percentage of the referred hearing screening babies, the false positive rate was 77.1% （104/135）. Conclusions： Newborn hearing screening programs are performed widely in China. As the program progresses, the outcome of hearing screening occurs. Although the rate is very low, the number of false positives is not less, and many adverse effects follow, such as parental anxiety, consent, disturbance to family functioning, long negative effects on the relationship between parent and infant. The possible causes and the management for reducing the false positives should be further studied.