Yu Yongfei, Zhang Kaiyu, Gao Jinglin, Huang Guoshun, Yong Chen, Wei Yuan, Zhou Enchao
Jiangsu University Key Laboratory of TCM Nourishing Kidney Essence and Anti-Aging Research, The First Clinical Medical College, Nanjing University of Chinese Medicine, Nanjing, China.
Division of Nephrology, Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu Province Hospital of Chinese Medicine, Nanjing, China.
PLoS One. 2025 Mar 25;20(3):e0320585. doi: 10.1371/journal.pone.0320585. eCollection 2025.
Sodium zirconium cyclosilicate (SZC) is a novel therapeutic agent for hyperkalemia. However, limited reports have described its real-world safety. In this study, we used the Food and Drug Administration Adverse Event Reporting System (FAERS) database to evaluate the safety profilet of SZC. This retrospective analysis involved FAERS data from the third quarter of 2018 to the fourth quarter of 2023. A disproportionality analysis, including reporting odds ratio (ROR), proportional reporting ratio (PRR), empirical bayesian geometric mean(EBGM), and bayesian confidence propagation neural network (BCPNN), was conducted to quantify the signals of SZC-related adverse events (AEs). Sex subgroup analyses were also conducted. A total of 1,154 SZC-related AE reports were obtained from the FAERS database. SZC-related AEs primarily targeted 21 system organ classes after simultaneously conforming to the four algorithms. The most common AEs included X-ray gastrointestinal tract abnormalities(ROR = 3888.02[1051.8, 14372.15]) and blood potassium abnormal(ROR = 212.53[134.73, 335.26]), consistent with prior findings and clinical trials. Unexpected significant AEs included ileus (ROR = 27.82[14.44, 53.59]), death (ROR = 17.49[15.7, 19.49]) and congestive cardiac failure (ROR = 16.66[10.94, 25.37]). Sex-based differences were observed for AEs. The median onset time of SZC-related AEs was 33 days. This study confirms common AEs of SZC and identifies new ones, highlighting the need for careful monitoring and facilitating its safe use in clinical settings. However, disproportionality analysis cannot formally prove causation and further studies are needed to confirm these associations.
环硅酸锆钠（SZC）是一种治疗高钾血症的新型药物。然而，关于其实际安全性的报道有限。在本研究中，我们使用美国食品药品监督管理局不良事件报告系统（FAERS）数据库来评估SZC的安全性概况。这项回顾性分析涉及2018年第三季度至2023年第四季度的FAERS数据。进行了不成比例分析，包括报告比值比（ROR）、比例报告比（PRR）、经验贝叶斯几何均值（EBGM）和贝叶斯置信传播神经网络（BCPNN），以量化与SZC相关的不良事件（AE）信号。还进行了性别亚组分析。从FAERS数据库中总共获得了1154份与SZC相关的AE报告。在同时符合四种算法后，与SZC相关的AE主要涉及21个系统器官类别。最常见的AE包括X线胃肠道异常（ROR = 3888.02[1051.8, 14372.15]）和血钾异常（ROR = 212.53[134.73, 335.26]），与先前的研究结果和临床试验一致。意外的显著AE包括肠梗阻（ROR = 27.82[14.44, 53.59]）、死亡（ROR = 17.49[15.7, 19.49]）和充血性心力衰竭（ROR = 16.66[10.94, 25.37]）。观察到AE存在基于性别的差异。与SZC相关的AE的中位发病时间为33天。本研究证实了SZC的常见AE并发现了新的AE，强调了仔细监测的必要性，并促进其在临床环境中的安全使用。然而，不成比例分析不能正式证明因果关系，需要进一步研究来证实这些关联。
