非ステロイド性抗炎症剤の安全性の評価に関する文献的考察

Abstract

In the past decade, many new non-steroidal anti-inflammatory drugs (NSAIDs) havebeen introduced into Japan and they are now widely used to treat inflammatory andrheumatic disorders. NSAIDs have recently received a great deal of attention because ofreports of various adverse reactions. However, the frequency of the adverse reactions to NSAIDs has varied among the clinical studies. Special caution should be taken wheninterpreting the data on adverse reactions in clinical studies carried out in different patientsby different physicians. It is the purpose of this study to evaluate accurately theclinical safety of NSAIDs. Twelve acidic NSAIDs were examined for which clinicaldata were published in comparison with indometacin in double blind trials in patientswith rheumatoid arthritis. The ratio of the test drug to the standard drug indometacin inthe frequency of adverse reactions in each trial was used as an index of the frequency ofadverse reactions to each NSAID. Discussion of the comparative frequency of adversereactions among the various NSAIDs was possible by using this index. The severity ofadverse reactions was estimated by observing the number of patients for whom themedication was withdrawn because of adverse reactions . The ratio of the test drug to thestandard drug in the frequency of withdrawal from each trial was used as an index of theseverity of the adverse reactions to each NSAID . The safety of drugs must be evaluatednot only by the frequency of the adverse reactions but also by their severity . It is suggested that the procedure described in this paper may be useful for evaluating the clinical safety of drugs.