目的 利用FAERS數(shù)據(jù)庫挖掘替那帕諾上市后在真實世界中的藥品不良事件信號，旨在為其在中國上市后的臨床安全合理使用提供參考。方法 提取FAERS數(shù)據(jù)庫中2019年第3季度—2025年第1季度與替那帕諾相關(guān)的不良事件報告數(shù)據(jù)，經(jīng)過數(shù)據(jù)清洗和標準化處理，采用報告比值比法（ROR）篩選其不良事件風險信號，挖掘出以替那帕諾為首要懷疑藥物的不良事件報告。同時將得到的不良事件信號與最新修訂的藥品說明書進行比對，挖掘潛在可疑的新的藥物不良事件。結(jié)果 共獲取以替那帕諾為首要懷疑藥物的不良事件報告2 088份，涉及患者1 066例，男性比例稍高于女性（47.66% vs 43.15%），主要上報國家是美國（81.43%）和日本（17.82%）。在剔除涉及藥物適應(yīng)證及排除超說明書使用、故意漏用藥物、產(chǎn)品處方問題等非正常用藥情況下的信號后共挖掘出相關(guān)不良事件風險信號54個，累及13個器官系統(tǒng)，不良事件信號中以腹瀉、死亡、住院治療、腹脹、腹痛、頭暈等報告頻次較高，還檢測到嘔吐、心臟停搏、低血壓、肌痙攣等說明書中未提及的不良事件，以及直腸出血、高血鉀癥等罕見的不良事件，值得進一步關(guān)注。結(jié)論 基于FAERS數(shù)據(jù)庫挖掘出的替那帕諾上市后在真實世界中發(fā)生的不良事件與藥品說明書具有一致性，但存在部分潛在可疑的新的藥物不良事件。在患者接受替那帕諾治療期間，臨床藥師和醫(yī)師對該部分不良事件要給予高度重視；對于其罕見的不良事件（如直腸出血），應(yīng)提高警惕并進一步加強臨床驗證。

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

郴州市科技發(fā)展計劃項目（ZDYF2020228）；科普研究重點項目（CMEI2024KPYJ00180）