日本人におけるアミオダロン肝障害の検討

概要

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Amiodarone has long been associated with liver damage, but very few such investigations have been conducted in Japan. The objective of the present study was to determine variations in liver enzymes, incidence of liver damage, and their relationships to dose and plasma concentrations following the start of amiodarone treatment in Japanese patients. Liver enzyme levels and their relationships to dose and plasma concentrations of amiodarone and desethylamiodarone during the first year following the start of treatment were retrospectively analyzed in 252 patients administered amiodarone between 1996 and 2002. Amiodarone-induced liver damage was defined as serum Aspartate amino trans terase (AST) and alanine amino trans terafe (ALT) levels elevated two-fold or more of the upper limit of normal level for which other causes were ruled out, while liver toxicity was defined as a three-fold increase. Liver damage during treatment was observed in 5.9% of patients. Liver toxicity was observed in only two patients, and both showed intraindividual variation, with dose-dependent variation in liver enzyme levels. A weak correlation (r=0.32, p=0.004) was observed between desethylamiodarone and AST. The incidence of liver damage was low for low-dose amiodarone treatment, and no dose-dependent increases in liver enzymes were observed. However, dose and plasma concentration-dependent liver damage may occur at higher doses.
東京女子医科大学の論文