目的 利用FAERS数据库挖掘替那帕诺上市后在真实世界中的药品不良事件信号，旨在为其在中国上市后的临床安全合理使用提供参考。方法 提取FAERS数据库中2019年第3季度—2025年第1季度与替那帕诺相关的不良事件报告数据，经过数据清洗和标准化处理，采用报告比值比法（ROR）筛选其不良事件风险信号，挖掘出以替那帕诺为首要怀疑药物的不良事件报告。同时将得到的不良事件信号与最新修订的药品说明书进行比对，挖掘潜在可疑的新的药物不良事件。结果 共获取以替那帕诺为首要怀疑药物的不良事件报告2 088份，涉及患者1 066例，男性比例稍高于女性（47.66% vs 43.15%），主要上报国家是美国（81.43%）和日本（17.82%）。在剔除涉及药物适应证及排除超说明书使用、故意漏用药物、产品处方问题等非正常用药情况下的信号后共挖掘出相关不良事件风险信号54个，累及13个器官系统，不良事件信号中以腹泻、死亡、住院治疗、腹胀、腹痛、头晕等报告频次较高，还检测到呕吐、心脏停搏、低血压、肌痉挛等说明书中未提及的不良事件，以及直肠出血、高血钾症等罕见的不良事件，值得进一步关注。结论 基于FAERS数据库挖掘出的替那帕诺上市后在真实世界中发生的不良事件与药品说明书具有一致性，但存在部分潜在可疑的新的药物不良事件。在患者接受替那帕诺治疗期间，临床药师和医师对该部分不良事件要给予高度重视；对于其罕见的不良事件（如直肠出血），应提高警惕并进一步加强临床验证。

Objective To mine the signals of adverse drug events in the real world after the launch of tenapanor by FAERS database, aiming to provide a reference for its clinical safe and reasonable use after the launch of tenapanor in China. Methods The adverse event reporting data related to tenapanor from the FAERS database from the 3rd quarter of 2019 to the 1st quarter of 2025 were extracted. After data cleaning and standardization, the adverse event risk signals were screened using the reporting odds ratio method (ROR) to mine adverse event reports with tenapanor as the primary suspected drug were mined. At the same time, the obtained adverse event signals are compared with the latest revised drug instructions to explore potentially suspicious new drug adverse events. Results A total of 2 088 adverse events reported with tenapanor as the primary suspected drug were obtained, involving 1 066 patients, with a slightly higher proportion of men than women (47.66% vs 43.15%). The main reporting countries were the United States (81.43%) and Japan (17.82%). After removing signals involving drug indications and excluding abnormal medications such as drug use, intentional misuse of drugs, product prescription problems, etc., a total of 54 related adverse events risk signals were excavated, involving 13 organ systems. Among the adverse event signals, diarrhea, death, hospitalization, abdominal distension, abdominal pain, dizziness, etc., were also detected. Adverse events not mentioned in the instructions, such as vomiting, cardiac arrest, hypotension, muscle spasm, as well as rare adverse events such as rectal bleeding and hyperkalemia, which deserve further attention. Conclusion The adverse events that occurred in the real world after the launch of tenapanor were mined based on the FAERS database are consistent with the drug instructions, but there are some potentially suspicious new drug adverse events. During the patient’s treatment with tenapanor, clinical pharmacists and physicians should pay great attention to this part of the adverse events; for rare adverse events (such as rectal bleeding), vigilance should be raised and clinical verification should be further strengthened.

R983

郴州市科技发展计划项目（ZDYF2020228）；科普研究重点项目（CMEI2024KPYJ00180）