Raeder E A, Podrid P J, Lown B
Am Heart J. 1985 May;109(5 Pt 1):975-83. doi: 10.1016/0002-8703(85)90238-8.
To assess the incidence of adverse effects associated with long-term amiodarone therapy, we reviewed the records of 217 consecutive patients who were treated for refractory arrhythmia. After an average of 11.8 months of therapy, one or more side effects occurred in 113 patients (52%). These were considered clinically significant in 42 patients (19.3%), mandating discontinuation of amiodarone in 18 (8.3%). The untoward reactions requiring discontinuation of amiodarone included thyroid dysfunction, visual disturbances, pulmonary infiltrates, ataxia, cardiac conduction abnormalities, and drug interactions. The mild side effects included corneal microdeposits, skin rashes, and gastrointestinal symptoms. There was a weak correlation between blood levels of amiodarone, the daily dose, and the cumulative dose (r = 0.23, p = 0.015). Drug levels were higher in symptomatic patients (p less than 0.03), although they received lower doses of amiodarone. While amiodarone is associated with frequent side effects, they are generally mild and do not necessitate drug discontinuation. Careful monitoring of therapy is essential to detect the potentially serious adverse reactions which are encountered in nearly 20% of patients.
为评估长期胺碘酮治疗相关不良反应的发生率，我们回顾了217例连续治疗难治性心律失常患者的病历。平均治疗11.8个月后，113例患者（52%）出现了一种或多种副作用。其中42例患者（19.3%）的副作用具有临床意义，18例患者（8.3%）因此停用胺碘酮。需要停用胺碘酮的不良反应包括甲状腺功能障碍、视觉障碍、肺部浸润、共济失调、心脏传导异常和药物相互作用。轻微副作用包括角膜微沉积、皮疹和胃肠道症状。胺碘酮血药浓度、每日剂量和累积剂量之间存在弱相关性（r = 0.23，p = 0.015）。有症状患者的药物浓度较高（p < 0.03），尽管他们接受的胺碘酮剂量较低。虽然胺碘酮常伴有副作用，但一般较轻微，不一定需要停药。密切监测治疗对于发现近20%患者中出现的潜在严重不良反应至关重要。
