Rankin Stephen, Elder Douglas H, Ogston Simon, George Jacob, Lang Chim C, Choy Anna Maria
College of Medical, Veterinary Life Sciences, University of Glasgow, Glasgow, UK.
Division of Cardiovascular and Diabetes Medicine, Ninewells Hospital and Medical School, University of Dundee, Dundee, UK.
Cardiovasc Ther. 2017 Jun;35(3). doi: 10.1111/1755-5922.12258.
Amiodarone is associated with significant long-lasting adverse drug reactions (ADRs). Guidelines recommend laboratory monitoring during long-term use. However, data of compliance with laboratory monitoring are lacking.
The aim of this study was to assess laboratory monitoring of liver and thyroid function during amiodarone prescribing from 1989 to 2011 in the Tayside, UK, population (approximately 400 000) in relation to National Guidelines recommending laboratory monitoring every 6 months. We also report the population-level incidence of abnormal liver and thyroid function in relation to total exposure of amiodarone.
Utilizing well-established record-linkage database, a longitudinal retrospective analysis of 1413 patients on long-term amiodarone was carried out, analyzing prescribing, biochemical, and clinical data.
Forty-six percent (46%), 28%, and 21% of patients underwent liver, thyroid, and combined testing, respectively, in accordance with guideline recommendations. Thirteen percent and 17% of patients did not have any ALT or TSH testing, respectively. During follow-up, 117 (9.5%) patients had an ALT 3×ULN and 16% patients had an abnormal TSH, (n=125, <0.4 mU/L and n=28, >10 mU/L). One hundred and forty patients (10%) required thyroxine replacement therapy, and 40 (3%) required on hyperthyroid medication. Total amiodarone exposure increased the likelihood of abnormal biochemical testing 2.5-fold after 4 years therapy for liver and thyroid function (P<.0005).
In this population-based study, adherence to laboratory monitoring guidelines was suboptimal. There was a positive correlation with total amiodarone exposure and biochemical abnormalities and development of thyroid disease compared to the general population, highlighting the need for improvement and continued amiodarone monitoring.
胺碘酮与显著的长期药物不良反应（ADR）相关。指南建议在长期使用期间进行实验室监测。然而，缺乏关于实验室监测依从性的数据。
本研究的目的是评估1989年至2011年期间英国泰赛德地区（约40万人口）在开具胺碘酮处方时，根据国家指南建议每6个月进行一次实验室监测的情况下，肝脏和甲状腺功能的实验室监测情况。我们还报告了与胺碘酮总暴露相关的肝脏和甲状腺功能异常的人群水平发病率。
利用完善的记录链接数据库，对1413例长期服用胺碘酮的患者进行了纵向回顾性分析，分析了处方、生化和临床数据。
分别有46%、28%和21%的患者按照指南建议进行了肝脏、甲状腺和联合检测。分别有13%和17%的患者未进行任何谷丙转氨酶（ALT）或促甲状腺激素（TSH）检测。在随访期间，117例（9.5%）患者的ALT超过正常上限（ULN）的3倍，16%的患者TSH异常（n = 125，<0.4 mU/L和n = 28，>10 mU/L）。140例（10%）患者需要甲状腺素替代治疗，40例（3%）患者需要抗甲状腺药物治疗。在治疗4年后，胺碘酮总暴露使肝脏和甲状腺功能生化检测异常的可能性增加了2.5倍（P <.0005）。
在这项基于人群的研究中，对实验室监测指南的依从性欠佳。与普通人群相比，胺碘酮总暴露与生化异常及甲状腺疾病的发生呈正相关，突出了改进和持续监测胺碘酮的必要性。
