一项关于钙调磷酸酶抑制剂相关心脏损害的药物警戒研究: 特别关注心室肥厚

doi:10.5246/jcps.2025.08.054

中国药学(英文版) ›› 2025, Vol. 34 ›› Issue (8): 732-740.DOI: 10.5246/jcps.2025.08.054

一项关于钙调磷酸酶抑制剂相关心脏损害的药物警戒研究: 特别关注心室肥厚

余馨¹^,²^,^#, 王欣蕊¹^,^#, 安卓玲¹, 冯欣²^,^*(), 杨辉¹^,^*()

^1. 首都医科大学附属北京朝阳医院药事部, 北京 100020
^2. 首都医科大学附属北京妇产医院药事部, 北京 100026

收稿日期:2025-03-23 修回日期:2025-04-06 接受日期:2025-06-24 出版日期:2025-08-29 发布日期:2025-08-29
通讯作者: 冯欣, 杨辉

Pharmacovigilance study on cardiac involvement associated with calcineurin inhibitors: focus on ventricular hypertrophy

Xin Yu¹^,²^,^#, Xinrui Wang¹^,^#, Zhuoling An¹, Xin Feng²^,^*(), Hui Yang¹^,^*()

¹ Department of Pharmacy, Beijing Chao-Yang Hospital, Capital Medical University, Beijing 100020, China
² Department of Pharmacy, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing 100026, China

Received:2025-03-23 Revised:2025-04-06 Accepted:2025-06-24 Online:2025-08-29 Published:2025-08-29
Contact: Xin Feng, Hui Yang
About author:
^# Xin Yu and Xinrui Wang contributed equally to this manuscript.

摘要/Abstract

摘要：

钙调磷酸酶抑制剂 (CNIs)显著提高了器官和患者的移植存活率。然而, 由于潜在致命的心室肥厚风险, 其安全性受到了广泛关注。我们进行了一项观察性的回顾性药物警戒研究, 用于评估与CNIs相关的心室肥厚, 包括其临床特征、不同人群中的风险以及导致致命结果的因素, 使用了美国食品药品监督管理局(FDA)不良事件报告系统(FAERS)的真实世界数据, 覆盖了从数据库建立到2023年第三季度的时期。共识别出131例与CNIs相关的心室肥厚病例。研究揭示了CNIs与心室肥厚之间存在的显著关联[ROR = 3.03 (2.54–3.61), IC = 1.55 (1.29–1.81)]。男性是CNIs相关心室肥厚致命结果的危险因素(P = 0.005)。临床医生应提高对CNIs相关心室肥厚的认识, 并关注长期接受CNIs治疗的患者心脏功能的定期评估结果, 包括整体和区域心脏受累情况, 特别是老年男性患者。

关键词: 钙调磷酸酶抑制剂, 心室肥厚, 肥厚性心肌病, 美国食品药品监督管理局不良事件报告系统, 药物警戒, 不成比例分析, 真实世界研究

Abstract:

Calcineurin inhibitors (CNIs) have significantly enhanced both organ and patient survival rates following transplantation. However, their safety profile remains a concern due to the heightened risk of ventricular hypertrophy, a condition that can be life-threatening. This study aimed to evaluate the clinical characteristics, population-specific risks, and contributing factors to fatal outcomes associated with CNI-induced ventricular hypertrophy. We conducted an observational, retrospective pharmacovigilance analysis utilizing real-world data from the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database, spanning from its inception until the third quarter of 2023. A total of 131 cases of CNI-related ventricular hypertrophy were identified, with our findings demonstrating a significant correlation between CNIs and ventricular hypertrophy [ROR = 3.03 (2.54–3.61), IC = 1.55 (1.29–1.81)]. Male patients were found to have an increased risk of fatal outcomes in CNI-associated ventricular hypertrophy (P = 0.005). Given these findings, clinicians are urged to maintain heightened vigilance regarding this severe complication. Regular and comprehensive cardiac function assessments, including both global and regional cardiac evaluations, are particularly recommended for patients on long-term CNI therapy, with a specific focus on older male individuals.

Key words: Calcineurin inhibitors, Ventricular hypertrophy, Hypertrophic cardiomyopathy, FDA Adverse Events Reporting System, Pharmacovigilance, Disproportionality analysis, Real-world study

Supporting:

余馨, 王欣蕊, 安卓玲, 冯欣, 杨辉. 一项关于钙调磷酸酶抑制剂相关心脏损害的药物警戒研究: 特别关注心室肥厚[J]. 中国药学(英文版), 2025, 34(8): 732-740.

Xin Yu, Xinrui Wang, Zhuoling An, Xin Feng, Hui Yang. Pharmacovigilance study on cardiac involvement associated with calcineurin inhibitors: focus on ventricular hypertrophy[J]. Journal of Chinese Pharmaceutical Sciences, 2025, 34(8): 732-740.

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参考文献 17

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一项关于钙调磷酸酶抑制剂相关心脏损害的药物警戒研究: 特别关注心室肥厚

Pharmacovigilance study on cardiac involvement associated with calcineurin inhibitors: focus on ventricular hypertrophy

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