Top 30 PTs by number of reported cases.

The aim of this study was to investigate frequencies, types, and signals of adverse drug events (ADEs) associated with sodium zirconium cyclosilicate (SZC) used for the treatment of hyperkalemia, in order to inform clinicians of possible safety concerns linked with SZC in real-life usage. ADE reports associated with SZC were collected from both the FAERS and VigiAccess databases. Data extraction from FAERS was performed using OpenVigil 2.1, covering reports from the first quarter of 2004 through the third quarter of 2024. The VigiAccess database was retrieved for reports up to February 5, 2025. The ADEs were standardized and classified by using the preferred term (PT) and the system organ class (SOC) of the Medical Dictionary for Regulatory Activities (MedDRA) (Version 27.0). The reporting odds ratio (ROR) method and the proportional reporting ratio (PRR) method were used to screen positive signals and analyze the characteristics of ADE signals. In this study, 1384 and 1518 ADE reports related to SZC were obtained from the FAERS database and the VigiAccess database, respectively. At the SOC level, the ADEs retrieved in the two databases involved 26 SOCs, and the top 3 SOCs in terms of the number of reported cases were general disorders and administration site conditions, gastrointestinal disorders, and investigations. At the PT level, among the top 30 PTs in terms of the number of reported cases in the two databases, death, cardiac failure, weight increased, blood pressure increased, cardiac failure congestive, cerebrovascular accident, myocardial infarction, pneumonia, dizziness, dysphagia, and dyspnoea were the ADEs with higher number of reported cases not included in the drug instructions. A total of 41 positive signals were obtained after signal screening in FAERS database. Among them, the top 3 PTs in terms of signal strength were blood potassium abnormal (ROR = 180.224[119.925, 270.842]), blood potassium increased (ROR = 98.789[78.835, 123.792]), blood sodium increased (ROR = 35.248[14.624, 84.961]). Signals of cardiac disorders such as cardiac failure chronic, cardiac failure and cardiac failure congestive, signals of gastrointestinal disorders such as ileus and intestinal perforation, and signals of blood sodium increased and hypernatraemia are positive signals that deserve special attention. In this study, the common ADEs associated with SZC were confirmed, and several intriguing novel signals not included in the drug instructions were discovered, which would provide more safety reference data for the clinical use of SZC.

本研究旨在探讨用于治疗高钾血症的环硅酸锆钠（sodium zirconium cyclosilicate, SZC）相关药物不良事件（adverse drug events, ADEs）的发生频率、类型及信号，以期为临床医师提供该药物实际临床应用中的相关安全警示信息。本研究从美国食品药品监督管理局不良事件报告系统（FAERS）与世界卫生组织VigiAccess药品不良反应数据库（VigiAccess）中收集了与SZC相关的药物不良事件报告。其中，针对FAERS数据库的数据提取工作采用OpenVigil 2.1工具完成，覆盖了2004年第一季度至2024年第三季度的所有报告；VigiAccess数据库则检索了截至2025年2月5日的全部相关报告。本研究采用医学监管活动词典（Medical Dictionary for Regulatory Activities, MedDRA）第27.0版的首选术语（preferred term, PT）与系统器官分类（system organ class, SOC）标准，对收集到的药物不良事件进行标准化处理与分类。同时采用报告比值比（reporting odds ratio, ROR）法与比例报告比值比（proportional reporting ratio, PRR）法开展阳性信号筛选，并分析药物不良事件信号的特征。本研究分别从FAERS数据库与VigiAccess数据库中获取了1384例和1518例与SZC相关的药物不良事件报告。在系统器官分类层面，两个数据库检索到的药物不良事件共涉及26个系统器官分类，报告病例数排名前三的类别依次为全身性疾病与给药部位异常、胃肠道疾病以及实验室检查异常。在首选术语层面，两个数据库中报告病例数排名前30的首选术语里，死亡、心力衰竭、体重增加、血压升高、充血性心力衰竭、脑血管意外、心肌梗死、肺炎、头晕、吞咽困难及呼吸困难均为未收录于该药物说明书的高报告数药物不良事件。经FAERS数据库的信号筛查，共得到41个阳性信号。其中信号强度排名前三的首选术语分别为血钾异常（ROR=180.224[119.925, 270.842]）、血钾升高（ROR=98.789[78.835, 123.792]）及血钠升高（ROR=35.248[14.624, 84.961]）。此外，慢性心力衰竭、心力衰竭、充血性心力衰竭等心脏疾病相关信号，肠梗阻、肠穿孔等胃肠道疾病相关信号，以及血钠升高、高钠血症相关信号均为值得重点关注的阳性信号。本研究明确了SZC相关的常见药物不良事件，并发现了若干未收录于该药物说明书的潜在新型信号，可为该药物的临床应用提供更为全面的安全参考数据。