添付文書に見られるてんかん発作名称の不統一性 : てんかん発作分類の推移からの考察

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We conducted a survey of the terms used to describe epileptic seizures in package inserts to clarify the inconsistency in such terms and considered whether they could be due to the changeover to the revised classification of epileptic seizures. On the basis of clinical syndromes, and electroencephalograms (seizure types and intenctal expressions), the terms used to describe epileptic seizures in classifications from before 1981 were brought into line with those in the classification of the International League Against Epilepsy (ILAE) drawn up in 1981. We investigated the terms used for epileptic seizures and their degree of adherence to the new classification system for the package inserts of 42 original epilepsy products which were selected by doing searches using the key word "antiepileptics" h in a general search and epileptic seizures for a search in the "indications" section on the website of a package insert information provider (http://www pharmasys.gr.ip/, as of April, 2003). The terms used for epileptic seizures in the package inserts were based on the revised classification, old classifications, or both classifications. Further, about half of the package inserts used both the revised and the old terms in the same item and in some of the descriptions of the terms, the old term was used after the new one. Only one of 9 pharmaceutical products marketed since 1981 conformed to the new classification. The results of the present study suggest that the inconsistencies in epileptic seizure terminology in package inserts is not due to the changeover from the old to the revised classification
日本医療薬学会の論文
2005-01-10

添付文書に見られるてんかん発作名称の不統一性 : てんかん発作分類の推移からの考察

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