Li Hao, Jiang Manxue, Pan Xiaona, Kong Lingti
Department of Pharmacy, The First Affiliated Hospital of Bengbu Medical University, Bengbu, China.
School of Pharmacy, Bengbu Medical University, Bengbu, China.
Front Pharmacol. 2025 Jan 24;16:1524702. doi: 10.3389/fphar.2025.1524702. eCollection 2025.
Voriconazole is a broad-spectrum antifungal agent. It is used widely for the prevention and treatment of invasive fungal infections in patients with a hematological malignancy, but studies on its safety in this population are scarce. We assessed the adverse drug events (ADEs) of voriconazole in this population based on the US Food and Drug Administration Adverse Event Reporting System (FAERS) database to improve understanding of the safety of voriconazole.
ADE reports for patients with a hematological malignant tumor using voriconazole between the first quarter of 2004 to the first quarter of 2024 were retrieved. Then, they were classified using the preferred terminology (PT) and system organ category (SOC) in the Medical Dictionary for Regulatory Activities. Data mining was done using reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS).
A total of 605 ADEs were included: 116 (19.17%) in children and 489 (80.83%) in adults. The types of SOC involved in children and adults were 22 and 24, respectively. The only positive SOC signal that satisfied all four algorithms simultaneously in children was "psychiatric disorders", whereas in adults they were "endocrine disorders" and "hepatobiliary disorders". At the PT level, the types involved in children and adults were 28 and 74, respectively. The highest ROR signal intensities were found for "hallucinations, mixed" in children and "toxic optic neuropathy" in adults. The median time of onset of the ADE in children and adults was 11 and 8.5 days, respectively.
We used four algorithms (ROR, PRR, BCPNN, MGPS) to mine the signals of voriconazole in patients with a hematological malignant tumor, and compared the differences between children and adults. This study is important for targeting the monitoring, and could help to improve the safety of voriconazole.
伏立康唑是一种广谱抗真菌药。它被广泛用于预防和治疗血液系统恶性肿瘤患者的侵袭性真菌感染，但关于其在该人群中的安全性研究较少。我们基于美国食品药品监督管理局不良事件报告系统（FAERS）数据库评估伏立康唑在该人群中的药物不良事件（ADEs），以增进对伏立康唑安全性的了解。
检索2004年第一季度至2024年第一季度期间使用伏立康唑的血液系统恶性肿瘤患者的ADE报告。然后，使用《监管活动医学词典》中的首选术语（PT）和系统器官类别（SOC）对其进行分类。使用报告比值比（ROR）、比例报告比（PRR）、贝叶斯置信传播神经网络（BCPNN）和多项目伽马泊松收缩器（MGPS）进行数据挖掘。
共纳入605例ADEs：儿童116例（19.17%），成人489例（80.83%）。儿童和成人涉及的SOC类型分别为22种和24种。在儿童中唯一同时满足所有四种算法的阳性SOC信号是“精神障碍”，而在成人中是“内分泌疾病”和“肝胆疾病”。在PT水平上，儿童和成人涉及的类型分别为28种和74种。儿童中“混合性幻觉”和成人中“中毒性视神经病变”的ROR信号强度最高。儿童和成人ADE的中位发病时间分别为11天和8.5天。
我们使用四种算法（ROR、PRR、BCPNN、MGPS）挖掘血液系统恶性肿瘤患者中伏立康唑的信号，并比较儿童和成人之间的差异。本研究对于有针对性的监测具有重要意义，并有助于提高伏立康唑的安全性。
