Department of Pharmacy, West China Second University Hospital, Sichuan University, Chengdu, China.
Evidence-Based Pharmacy Center, West China Second University Hospital, Sichuan University, Chengdu, China.
Sci Rep. 2023 Mar 18;13(1):4475. doi: 10.1038/s41598-023-27687-0.
Though triazole antifungals are the first choice for preventing and treating invasive fungal infections, periostitis caused by voriconazole has been described in emerging case reports; however, no studies exist on this association in real-world clinical settings. Our study aimed to identify the association between periostitis and triazole antifungals by analyzing data from the FDA Adverse Event Reporting System (FAERS). We extracted and analyzed reports on the association between periostitis and triazole antifungals in FAERS from the first quarter of 2004 to the second quarter of 2022 using OpenVigil 2.1. Disproportionality analysis was performed to evaluate the association between periostitis and triazole antifungals, and chi-squared (χ), relative reporting ratio (RRR), reporting odds ratio (ROR), proportional reporting ratio (PRR), and Bayesian confidence propagation neural networks (BCPNN) of information components (IC) were reported. In total, 143 patients experienced periostitis while using voriconazole. Disproportionality analysis identified an association between periostitis and voriconazole (χ = 82,689.0, RRR = 583.6, 95%CI [472.4, 721.1], PRR = 1808.9, 95%CI [1356.0, 2412.9], ROR = 1831.7, 95%CI [1371.6, 2446.3], IC = 9.2, 95%CI [8.6, 9.8]). However, no safety signals were observed between periostitis and other triazole antifungals. When stratified by sex and age, disproportionality analysis identified positive signals between periostitis and voriconazole. The possible association between periostitis and voriconazole should attract sufficient attention in clinical practice. Alternative treatment with other triazole antifungals can be considered, and causality needs to be verified in further prospective studies.
虽然三唑类抗真菌药是预防和治疗侵袭性真菌感染的首选药物,但已有报道称伏立康唑可引起骨膜炎;然而,在真实临床环境中,尚未有关于这种关联的研究。我们的研究旨在通过分析 FDA 不良事件报告系统 (FAERS) 的数据,确定骨膜炎与三唑类抗真菌药之间的关联。我们使用 OpenVigil 2.1 从 2004 年第一季度到 2022 年第二季度提取并分析了 FAERS 中关于骨膜炎与三唑类抗真菌药之间关联的报告。使用卡方 (χ)、相对报告比值 (RRR)、报告比值比 (ROR)、比例报告比值 (PRR) 和贝叶斯置信传播神经网络 (BCPNN) 信息成分 (IC) 对骨膜炎与三唑类抗真菌药之间的关联进行了不均衡性分析。共有 143 例患者在使用伏立康唑时发生骨膜炎。不均衡性分析确定了骨膜炎与伏立康唑之间存在关联 (χ=82689.0,RRR=583.6,95%CI [472.4,721.1],PRR=1808.9,95%CI [1356.0,2412.9],ROR=1831.7,95%CI [1371.6,2446.3],IC=9.2,95%CI [8.6,9.8])。然而,在其他三唑类抗真菌药与骨膜炎之间未观察到安全信号。按性别和年龄分层后,不均衡性分析确定了骨膜炎与伏立康唑之间存在阳性信号。在临床实践中,应充分关注骨膜炎与伏立康唑之间的潜在关联。可以考虑使用其他三唑类抗真菌药进行替代治疗,并且需要在进一步的前瞻性研究中验证因果关系。