Abstract

With the objective of determining the causative factors underlying drug side effects, a pharmacoepidemiological study was conducted using three injection drugs, cefotaxime, cefoperazone and latamoxef, which in Japan, are referred to as third-generation cephem antibiotics. An analytical investigation of 150 items, including medicated drugs and bioinformation, was conducted on the medical records of 600 hospitalized patients, all of whom had been administered one of these injection drugs.Principal component analysis and multivariate logistic analysis were conducted on 11 factors, whose significance had been demonstrated previously by univariate analysis, to examine the degree of their association with the presence or absence of side effects from drug administration. The results of principal component analysis revealed that these 11 factors were classified into the categories of the first to the fifth factors. Combined together, these factor groups were found to be associated with the side effects of the three antibiotics under investigation. Five factors with suspected etiologic involvement in the occurrence of side effects were selected for further investigation in accordance with the Akaike-Minimum-AIC method and included the method of administration, leukocyte counts, total administration dose, existence of cancer disease, and combined use of drugs with a hemorrhage-inducing tendency. The present analysis suggested that the relative risk of developing side effects increases when these five factors are combined together, and that this closely reflects the predictive formula of side effect manifestation.

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