スティーブンス・ジョンソン症候群(Stevens-Johnson syndrome:SJS)と中毒性表皮壊死症(toxic epidermal necrolysis:TEN)は、薬剤性過敏症症候群(DIHS)と並ぶ代表的な重症薬疹。重症の場合は全身の皮膚が剥がれて重症のやけどのようになります。

 人口100万人あたり1~6名の発症率(「重篤副作用疾患別対応マニュアル」より)なので、投与してみないとわからない怖さを感じながら調剤をしています。

 さて、SJSやTENなどの表皮性壊死症(Epidermal necrolysis:EN)の薬剤性を鑑別するアルゴリズム(algorithm of drug causality for EN:ALDEN)が、これまでのFrench pharmacovigilance methodよりも、有意に優れていたという報告。

Clin Pharmacol Ther. 2010 Jul;88(1):60-8. Epub 2010 Apr 7.

ALDEN, an algorithm for assessment of drug causality in Stevens-Johnson Syndrome and toxic epidermal necrolysis: comparison with case-control analysis.

Epidermal necrolysis (EN)–either Stevens-Johnson syndrome (SJS) or toxic EN (TEN)–is a severe drug reaction. We constructed and evaluated a specific algorithm, algorithm of drug causality for EN (ALDEN), in order to improve the individual assessment of drug causality in EN. ALDEN causality scores were compared with those from the French pharmacovigilance method in 100 cases and the case-control results of the EuroSCAR study. Scores attributed by ALDEN segregated widely. ALDEN pointed to a “probable” or “very probable” causality in 69/100 cases as compared to 23/100 with the French method (P < 0.001). It scored “very unlikely” causality for 64% of medications vs. none with the French method. Results of ALDEN scores were strongly correlated with those of the EuroSCAR case-control analysis for drugs associated with EN (r = 0.90, P < 0.0001), with probable causality being reported in 218/329 exposures. ALDEN excluded causality in 321 drugs that the case-control analysis had described as “probably not associated” and in 22/233 drugs that had been described as inconclusive exposures. Being more sensitive than a general method, ALDEN, which correlates well with case-control analysis results, can be considered a reference tool in SJS/TEN.

気づき)

・「個別症例安全性報告の因果関係評価基準」にはいろいろな論議があるようです

・予測ができる検査や因子があれば、いいのだけれど・・・

これから)

研究日

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カテゴリー: EBM

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