Robert E, Vollset S E, Botto L, Lancaster P A, Merlob P, Mastroiacovo P, Cocchi G, Ashizawa M, Sakamoto S, Orioli I
Central-East France Registry of congenital malformations, Institut Européen des Génomutations, 86, rue E. Locard, F-69005 Lyon, France.
Int J Risk Saf Med. 1994;6(2):75-118. doi: 10.3233/JRS-1994-6201.
A project implemented within the framework of the International Clearinghouse for Birth Defect Monitoring Systems is named MADRE: MAlformation DRug Exposure surveillance. The idea is to survey the simultaneous occurrence of malformations and first-trimester drug exposures. In a 2-year period 1990-91, this has yielded 1448 infants known to have been exposed to drugs and that are known to have malformations. Cases have been reported by eight programs: Australia, Central-East France, Israel, Italy IPIMC, Italy IMER, Japan Red Cross Hospitals, Japan Maternal Health and Welfare, and South America. By searching this databank for associations between drugs and malformations, specific relationships can be detected.The 9th revision of the WHO International Classification of Diseases, adapted by the British Paediatric Association, known as ICD9/BPA is used for coding malformations. This is a hierarchical system with 5 digits as the maximum level of specification of each malformation.The ATC (Anatomical Therapeutic Chemical) classifications system is used for coding drugs. This is a multiple level, hierarchical classification with up to 7 digits for specifying each drug.Up to five drugs and malformations are coded for each case using ATC and ICD9/BPA classifications, and all observed drug-malformation pairs form the basis for the analysis. For each drug-malformation combination where three or more cases are observed, a set of 2×2 tables is formed and analyzed as in case-control studies. The odds ratio for the pair, stratified for program, gives the relative risk for the malformation in question, comparing use of the specific drug with all other drugs.Well known or controversial associations were tested in the collected material, and at this stage only one new association is suggested, that is between cardiac defects and maternal treatment with thyroid hormones. This finding has to be further explored with new data.
在国际出生缺陷监测系统信息交换所框架内实施的一个项目名为MADRE：畸形与药物暴露监测。其目的是调查畸形与孕早期药物暴露的同时发生情况。在1990 - 1991年的两年时间里，该项目收集到1448例已知暴露于药物且患有畸形的婴儿病例。这些病例由八个项目报告：澳大利亚、法国中东部、以色列、意大利IPIMC、意大利IMER、日本红十字医院、日本母婴健康与福利以及南美洲。通过在这个数据库中搜索药物与畸形之间的关联，可以检测到特定关系。世界卫生组织国际疾病分类第9版经英国儿科学会改编后称为ICD9/BPA，用于对畸形进行编码。这是一个分层系统，每个畸形的最大详细程度为5位数字。ATC（解剖治疗化学）分类系统用于对药物进行编码。这是一个多层次的分层分类，指定每种药物最多可达7位数字。每个病例使用ATC和ICD9/BPA分类法对多达五种药物和畸形进行编码，所有观察到的药物 - 畸形对构成分析的基础。对于每种观察到三例或更多病例的药物 - 畸形组合，会形成一组2×2表格并像在病例对照研究中那样进行分析。按项目分层的该组合的优势比给出了所讨论畸形的相对风险，即将特定药物的使用与所有其他药物进行比较。在收集的材料中对已知或有争议的关联进行了测试，在此阶段仅提出了一种新的关联，即心脏缺陷与母亲使用甲状腺激素治疗之间的关联。这一发现必须用新数据进一步探究。
