薬剤性重症型皮膚障害の起因薬剤および患者背景に関する研究

概要

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The purpose of this study was to identify drugs with a risk of causing Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug-induced hypersensitivity syndrome (DIHS) and the risk factors involved. From the CARPIS (Case Reports of Adverse Drug Reactions and Poisoning Information System) database, which contains 40,000 case reports of adverse drug reactions, we determined 258 cases (case group) matching the criteria for SJS/TEN/DIHS stated by the Japanese Ministry of Health, Labour and Welfare. We also selected 774 control cases (control group) which were sex- and age- matched (±1) with the case group. Next, various data were compared between the case group and the control group and the results analyzed statistically. In this regard, logistic regression analysis identified 2 drugs - carbamazepine (odds ratio : OR = 5.21, 95% confidence interval: 95% CI=2.68-10.06) and acetaminophen (OR=3.41, 95% 1=1.12-10.51) that were associated with a significant elevation of the risk of SJS and TEN. Further, mexiletine hydrochloride (OR = 205.48, 95% CI = 28.04-2330.89) and diaminodiphenylsulfone (OR = 981.56, 95% CI = 94.84-25212.82), were found to be associated with a significant elevation of the risk of DIHS. By identifying certain risk factors for SJS, TEN and DIHS, the results of the present study would be useful in preventing severe drug reactions.
日本医療薬学会の論文
2007-06-10