Fujita Toshiharu, Miura Yoshihiko, Mayama Takeshi
Department of Epidemiology, National Institute of Public Health, Saitama, Japan.
Pharmacoepidemiol Drug Saf. 2005 Jan;14(1):41-6. doi: 10.1002/pds.1021.
In Japan, all patients are able to see freely any clinics or hospitals. So clinical data of all patients have been stored at clinics, hospitals and medical institutes respectively. These patients' clinical course data stocks have not been combined with one another. There is no large-scale database, which has been available and has played its role in complementing spontaneous adverse drug reaction (ADR) reporting system. We tried to build an original database using anti-hypertensive drugs' data from Drug Use Investigation conducted for the Japanese Drug Re-examination application by every pharmaceutical manufacturer in conformity with Japanese Pharmaceutical Affairs Law and Related Regulation.
The 43 565 case data of seven anti-hypertensive drugs (one Ca-antagonist, one alpha-blocker, two beta-blockers, three ACE inhibitors) were kindly offered from seven manufacturers who were members of RAD-AR Council, Japan. After examining the data items and categories, they were standardized into common codes based on Japanese Drug Category Classification (JDCC), International Classification of Diseases 9 (ICD-9) and Japanese Adverse Drug Reaction Terminology (J-ART). As each manufacturer had a different coding method in accordance to manufacturer's own practice of data management, the original forms were divided into several datasets. The data processing and statistical analysis were conducted using Statistical Analysis System (SAS).
(1) Technology and know-how to combine data coded by different methods were established for building a database that had never been tried in Japan. (2) The following are the by-products of the study: a) Onset of ADR concentrated in the early stage but onset of some disorders prevailed equally throughout the investigation period. b) Although the number of collected cases of anti-hypertensive drugs was 43 565, total number of administrated anti-hypertensive drugs reached to 70 714 because additional anti-hypertensive drugs were often used with subject drugs.
There is no large-scale database of patients' clinical course in Japan. However, since the Japanese Drug Re-examination System started in 1979, almost eight million cases of Drug Use Investigation on about 700 drugs have been collected with enormous human power and huge expenditure for Japanese Drug Re-examination application by pharmaceutical manufacturers. New and more appropriate information will be detected by the database, built using Drug Use Investigation data that were collected only for the Japanese Drug Re-examination application.
在日本，所有患者都可以自由就诊于任何诊所或医院。因此，所有患者的临床数据分别存储在诊所、医院和医学机构中。这些患者的临床病程数据存储尚未相互整合。目前还没有一个可用的大规模数据库，能在补充自发药品不良反应（ADR）报告系统方面发挥作用。我们试图利用各制药厂商按照日本药事法及相关规定为日本药品再审查申请所进行的药品使用调查中的抗高血压药物数据，构建一个原始数据库。
从日本RAD-AR委员会成员的七家制药厂商处获得了七种抗高血压药物（一种钙拮抗剂、一种α受体阻滞剂、两种β受体阻滞剂、三种血管紧张素转换酶抑制剂）的43565例病例数据。在检查数据项和类别后，根据日本药品分类（JDCC）、国际疾病分类第9版（ICD-9）和日本药品不良反应术语（J-ART）将其标准化为通用代码。由于每个厂商根据自身的数据管理实践有不同的编码方法，原始表格被分成了几个数据集。使用统计分析系统（SAS）进行数据处理和统计分析。
（1）建立了将不同编码方法编码的数据进行整合的技术和诀窍，以构建一个在日本从未尝试过的数据库。（2）以下是该研究的副产品：a）ADR的发生集中在早期，但某些疾病的发生在整个调查期间较为均匀。b）尽管收集的抗高血压药物病例数为43565例，但使用的抗高血压药物总数达到70714例，因为受试药物常与其他抗高血压药物联用。
日本没有大规模的患者临床病程数据库。然而，自1979年日本药品再审查制度启动以来（制药厂商为日本药品再审查申请投入了巨大人力和巨额资金），已收集了近800万例关于约700种药物的药品使用调查数据。利用仅为日本药品再审查申请收集的药品使用调查数据构建的数据库，将检测到新的且更合适的信息。
