Yang Jingrong, Zhang Guangheng, You Mengfan, Zhang Han, Shang Yonghan, Xing Kaidi, Ge Deye, Su Wenge, Wang Yifei
School of Traditional Chinese Medicine, Shandong University of Traditional Chinese Medicine, Jinan, China.
Department of Cardiovascular, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, China.
Expert Opin Drug Saf. 2024 Dec 10:1-11. doi: 10.1080/14740338.2024.2438742.
Amiodarone is used to treat cardiac arrhythmias but carries a risk of pulmonary toxicity. Despite this well-known side effect, there is currently no large descriptive case series studying amiodarone-induced pulmonary toxicity.
The reporting odds ratio (ROR) was utilized to quantify signals of amiodarone-related pulmonary adverse events (AEs) from 2004 to 2023. Severity comparisons between serious and non-serious cases were conducted using the Mann-Whitney U test or chi-square (χ2) test, and signal prioritization was achieved through rating scales.
A total of 4896 cases of amiodarone-related pulmonary AEs were found, and 56 signals were detected. 27 AEs were classified as serious adverse reactions, and 21 AEs were identified as new and unexpected signals. Even when stratified by age, weight, sex, and reporter type, the association between amiodarone and pulmonary diseases persisted. Seven strong clinical priority signals were defined. The median time to onset (TTO) for strong, moderate, and weak clinical priority signals was 221, 126, and 227 days, respectively. All disproportional signals exhibited an early failure-type pattern.
Our study offers a deeper and broader understanding of the pulmonary safety profile of amiodarone, which will aid healthcare professionals in mitigating the risk of pulmonary adverse events in clinical practice.
胺碘酮用于治疗心律失常，但存在肺毒性风险。尽管有这种众所周知的副作用，但目前尚无大型描述性病例系列研究胺碘酮所致肺毒性。
采用报告比值比（ROR）来量化2004年至2023年期间与胺碘酮相关的肺部不良事件（AE）信号。使用曼-惠特尼U检验或卡方（χ2）检验对严重和非严重病例的严重程度进行比较，并通过评分量表对信号进行优先级排序。
共发现4896例与胺碘酮相关的肺部AE病例，检测到56个信号。27例AE被归类为严重不良反应，21例AE被确定为新的和意外信号。即使按年龄、体重、性别和报告者类型进行分层，胺碘酮与肺部疾病之间的关联仍然存在。定义了7个强临床优先级信号。强、中、弱临床优先级信号的中位发病时间（TTO）分别为221天、126天和227天。所有不成比例信号均呈现早期失效型模式。
我们的研究对胺碘酮的肺部安全性概况提供了更深入和广泛的理解，这将有助于医疗保健专业人员在临床实践中降低肺部不良事件的风险。
