Fischer Alicia Jeanette, Enders Dominic, Eckardt Lars, Köbe Julia, Wasmer Kristina, Breithardt Günter, De Torres Alba Fernando, Kaleschke Gerrit, Baumgartner Helmut, Diller Gerhard-Paul
Department of Cardiology III-Adult Congenital and Valvular Heart Disease, University Hospital Muenster, D-48149 Muenster, Germany.
Institute of Biostatistics and Clinical Research, University Hospital Muenster, D-48149 Muenster, Germany.
J Clin Med. 2022 Apr 5;11(7):2027. doi: 10.3390/jcm11072027.
Background: Amiodarone has a profound adverse toxicity profile. Large population-based analyses quantifying the risk of thyroid dysfunction (TD) in adults with and without congenital heart disease (ACHD) are lacking. Methods: All adults registered with a major German health insurer (≈9.2 million members) with amiodarone prescriptions were analyzed. Occurrence of amiodarone-associated TD was assessed. Results: Overall, 48,891 non-ACHD (37% female; median 73 years) and 886 ACHD (34% female; median 66 years) received amiodarone. Over 184,787 patient-years, 10,875 cases of TD occurred. The 10-year risk for TD was 38% in non-ACHD (35% ACHD). Within ACHD, compared to amiodarone-naïve patients, the hazard ratio (HR) for TD was 3.9 at 4 years after any amiodarone exposure. TD was associated with female gender (HR 1.42, p < 0.001) and younger age (HR 0.97 per 10 years, p = 0.009). Patients with congenital heart disease were not at increased risk (HR 0.98, p = 0.80). Diagnosis of complex congenital heart disease, however, was a predictor for TD (HR 1.56, p = 0.02). Amiodarone was continued in 47% of non-ACHD (38% ACHD), and 2.3% of non-ACHD (3.5% ACHD) underwent thyroid surgery/radiotherapy. Conclusions: Amiodarone-associated TD is common and comparable in non-ACHD and ACHD. While female gender and younger age are predictors for TD, congenital heart disease is not necessarily associated with an elevated risk.
胺碘酮具有严重的不良毒性特征。目前缺乏基于大量人群的分析来量化有和没有先天性心脏病（ACHD）的成年人发生甲状腺功能障碍（TD）的风险。方法：对德国一家大型健康保险公司登记的所有开具胺碘酮处方的成年人（约920万成员）进行分析。评估胺碘酮相关TD的发生情况。结果：总体而言，48891名非ACHD患者（37%为女性；中位年龄73岁）和886名ACHD患者（34%为女性；中位年龄66岁）接受了胺碘酮治疗。在超过184787患者年中，发生了10875例TD。非ACHD患者TD的10年风险为38%（ACHD患者为35%）。在ACHD患者中，与未使用过胺碘酮的患者相比，任何胺碘酮暴露后4年TD的风险比（HR）为3.9。TD与女性性别（HR 1.42，p<0.001）和较年轻年龄（每10年HR 0.97，p=0.009）相关。先天性心脏病患者风险未增加（HR 0.98，p=0.80）。然而，复杂先天性心脏病的诊断是TD的一个预测因素（HR 1.56，p=0.02）。47%的非ACHD患者（38%的ACHD患者）继续使用胺碘酮，2.3%的非ACHD患者（3.5%的ACHD患者）接受了甲状腺手术/放疗。结论：胺碘酮相关TD在非ACHD和ACHD患者中很常见且相似。虽然女性性别和较年轻年龄是TD的预测因素，但先天性心脏病不一定与风险升高相关。
