目的 利用美國食品藥品管理局（FDA）不良事件報告系統(tǒng)（FAERS）數(shù)據(jù)庫分析維立西呱在真實世界中發(fā)生的藥物不良事件，為該藥的臨床安全使用提供參考。方法 采用報告比值比法和比例報告比值法對FAERS數(shù)據(jù)庫中2021年第1季度—2024年第2季度間以維立西呱為首要懷疑藥物的不良事件數(shù)據(jù)進行挖掘，利用《國際醫(yī)學(xué)用語詞典》的系統(tǒng)器官分類（SOC）和首選術(shù)語（PT）對不良事件進行分類及描述，篩選出以上2種方法的共有不良事件信號進行分析。結(jié)果 獲取得到維立西呱不良事件報告692例，報告對象以男性居多，年齡主要為50歲以上，報告國家或地區(qū)以美國、日本等為主，報告年份以2022、2023年為主，報告結(jié)局主要為死亡和住院。維立西呱信號挖掘得到11個SOC、23個PT信號。結(jié)論 本研究基于相關(guān)真實世界數(shù)據(jù)全面分析維立西呱上市后在實際臨床應(yīng)用中出現(xiàn)的不良事件特征，為臨床用藥安全和相關(guān)領(lǐng)域研究提供參考。

Objective To analyze the adverse drug events of vericiguat in the real world using FAERS database, and to provide reference for safe clinical medication. Methods The reporting odds ratio method and the proportional reporting ratio method were used to mine the adverse drug events data of vericiguat in the FAERS database from the first quarter of 2021 to the second quarter of 2024, with vericiguat as the primary suspected drugs. Classification and description of adverse drug events was conducted using the system organ class (SOC) and preferred term (PT) of the Medical Dictionary for Regulatory Activities. Common adverse drug events signals by above two methods were screened. Results A total of 692 cases of adverse drug events were obtained. Most patients were men, with the age of over 50 years old. The main sources of reported events were the United States and Japan. The reported events mainly occurred in 2022 and 2023. The main outcomes of reported events were death and hospitalization. Mining for vericiguat found that there were 11 SOCs and 23 PTs. Conclusion Based on the real-world data, this study comprehensively analyzed the adverse drug events characteristics in the actual clinical application of vericiguat, providing references for clinical use and related research.

R972

上海市科學(xué)技術(shù)委員會科研計劃項目(15411960110);上海市市級醫(yī)院新興前沿技術(shù)聯(lián)合攻關(guān)項目(SHDC12014107);海軍軍醫(yī)大學(xué)校級基礎(chǔ)醫(yī)學(xué)課題青年啟動基金(2022QN087)