Czeizel A E, Rockenbauer M, Siffel C, Varga E
Foundation for Community Control of Hereditary Diseases, Budapest, Hungary.
Teratology. 2001 May;63(5):176-85. doi: 10.1002/tera.1032.
The Hungarian Case-Control Surveillance of Congenital Abnormalities was established in 1980. This article describes how the Hungarian Case-Control Surveillance of Congenital Abnormalities was first organized and is currently maintained. The baseline statistics are provided and potential venues of postmarketing surveillance of drug teratogenicity and other public health tasks and research are proposed.
Cases with congenital abnormalities and patient controls with Down syndrome were selected from the Hungarian Congenital Abnormality Registry. Population controls without congenital abnormalities were selected from the National Birth Registry on the basis of three matching criteria: sex, week of birth, and district of parent's residence. Three sources of information concerning drug exposures, maternal disorders, and pregnancy complications, among others, were used: (1) prospective and medically recorded data from antenatal care logbooks and discharge summaries; (2) retrospective maternal self-reported data obtained with a structured questionnaire in all the three study groups; and (3) data collected by regional nurse in house visits to nonrespondent cases and patient controls. Twenty-five congenital abnormality groups were evaluated. During the 17-year period of data collection, 22,843 cases, 38,151 population controls, and 834 patient controls were incorporated into the data set, constituting the largest population-based case-control data set of congenital abnormalities to date.
Demographic features of pregnant women and informative offspring are presented along with the distribution of 25 main groups of congenital abnormalities.
This system is appropriate for postmarketing the surveillance of drug teratogenicity, for the improvement of congenital abnormality diagnosis, to get informed consent, to have a communication with parents and to provide material for research.
匈牙利先天性异常病例对照监测系统于1980年建立。本文描述了匈牙利先天性异常病例对照监测系统最初是如何组织的以及目前是如何维持的。提供了基线统计数据,并提出了药物致畸性上市后监测及其他公共卫生任务和研究的潜在途径。
先天性异常病例和唐氏综合征患者对照选自匈牙利先天性异常登记处。无先天性异常的人群对照根据三个匹配标准从国家出生登记处选取:性别、出生周数和父母居住地区。使用了有关药物暴露、母体疾病和妊娠并发症等的三种信息来源:(1)产前护理日志和出院小结中的前瞻性和医学记录数据;(2)在所有三个研究组中通过结构化问卷获得的回顾性母亲自我报告数据;(3)地区护士在对无回应的病例和患者对照进行家访时收集的数据。对25个先天性异常组进行了评估。在17年的数据收集期间,22843例病例、38151名人群对照和834名患者对照被纳入数据集,构成了迄今为止最大的基于人群的先天性异常病例对照数据集。
呈现了孕妇和有信息价值后代的人口统计学特征以及25个主要先天性异常组的分布情况。
该系统适用于药物致畸性的上市后监测、改善先天性异常诊断、获得知情同意、与父母沟通以及为研究提供素材。