目的 基于美國(guó)食品藥品管理局不良事件報(bào)告系統(tǒng)（FAERS）挖掘與分析瑪伐凱泰潛在的藥品不良事件信號(hào)，為臨床安全用藥提供參考。方法 利用線上藥物警戒工具Open Vigil 2.1版，收集FAERS數(shù)據(jù)庫(kù)中2022年4月1日—2024年9月30日的瑪伐凱泰相關(guān)不良事件報(bào)告，利用比例失衡法中的報(bào)告比值比法（ROR）和比例報(bào)告比值法（PRR）進(jìn)行數(shù)據(jù)挖掘。結(jié)果 經(jīng)數(shù)據(jù)清洗后，收集到瑪伐凱泰不良事件報(bào)告1 802份，共挖掘到43個(gè)有效不良事件信號(hào)，其中發(fā)生頻次較高的不良事件信號(hào)與藥品說明書中的基本一致。此外，還發(fā)現(xiàn)了心房顫動(dòng)、鼻咽炎、體質(zhì)量增加、尿路感染、高血壓等30個(gè)不良事件信號(hào)未被藥品說明書提及。結(jié)論 在臨床應(yīng)用瑪伐凱泰時(shí)，除了需重點(diǎn)關(guān)注藥品說明書中已明確的不良事件外，還應(yīng)警惕心房顫動(dòng)、鼻咽炎、尿路感染、體質(zhì)量增加、高血壓等藥品說明書未提及的不良事件。在用藥前及用藥過程中，應(yīng)監(jiān)測(cè)患者的左心室射血分?jǐn)?shù)（LVEF），避免LVEF降低、心力衰竭等嚴(yán)重不良反應(yīng)的發(fā)生，以確?；颊叩挠盟幇踩?。

Objective To mine and analyze potential adverse drug event signals associated with mavacamten based on the FAERS, providing reference for clinical medication safety. Methods Using the online pharmacovigilance tool Open Vigil version 2.1, adverse drug event reports related to mavacamten in the FAERS database from April 1, 2022, to September 30, 2024, were collected. Data mining was performed utilizing the reporting odds ratio (ROR) and proportional reporting ratio (PRR) methods. Results After data cleaning, a total of 1 802 adverse drug event reports related to mavacamten were collected, identifying 43 valid adverse drug event signals. The most frequently occurring adverse drug event signals were consistent with those specified in the product labeling. Additionally, 30 adverse drug event signals, including atrial fibrillation, nasopharyngitis, weight gain, urinary tract infection, and hypertension, were identified that were not mentioned in the product labeling. Conclusion When clinically applying mavacamten, it is crucial to not only monitor the adverse drug events explicitly listed in the product labeling but also to remain vigilant for unmentioned adverse drug events such as atrial fibrillation, nasopharyngitis, urinary tract infection, weight gain, and hypertension. Prior to and during treatment, patient LVEF should be monitored to prevent severe adverse reactions such as LVEF reduction and heart failure, ensuring medication safety for patients.

R972

中南大學(xué)教育教學(xué)改革項(xiàng)目（2023jy104）;中南大學(xué)研究生教育教學(xué)改革項(xiàng)目（2023JGB097）;美國(guó)中華醫(yī)學(xué)會(huì)基金(19-343)