目的 基于JADER數(shù)據(jù)庫挖掘羅沙司他的不良事件信號，評價羅沙司他在真實世界中的安全性，以期為臨床合理用藥提供參考。方法 收集JADER數(shù)據(jù)庫自2004年4月—2024年8月的不良事件報告數(shù)據(jù)，采用報告比值比法和綜合標(biāo)準(zhǔn)法進(jìn)行不良事件信號挖掘。結(jié)果 共收集到以羅沙司他為“可疑”藥物的不良事件報告2 997份，男性所占比例略高于女性，年齡集中在65～84歲。共挖掘出101個不良事件信號，其中發(fā)生頻數(shù)居前的不良事件信號與說明書基本一致，包括甲狀腺功能減退癥、大腦梗死、深靜脈血栓形成、高鉀血癥等。除此之外還發(fā)現(xiàn)了一些新的可疑不良反應(yīng)，如黃疸、高膽紅素血癥、視網(wǎng)膜出血等。結(jié)論 臨床上應(yīng)加強(qiáng)監(jiān)測患者的甲狀腺功能指標(biāo)、心腦血管功能、血鉀水平以及感染癥狀與體征，并警惕說明書未提及的不良事件信號，保障患者用藥安全。

Objective To detect adverse event signals of roxadustat based on the JADER database and evaluate its safety in the real world, so as to provide evidence for rational use of medicines. Methods The adverse event reports from April 2004 to August 2024 were collected. The adverse event signal were analyzed using the reporting odds ratio method and comprehensive standard method. Results A total of 2 997 adverse event reports related to roxadustat as “suspected” were collected. There was a slightly higher proportion of males. The age was mainly concentrated between 65 and 84 years. A total of 101 adverse event signals were identified. The signals with high frequency were consistent with the instruction basically, including hypothyroidism, cerebral infarction, deep vein thrombosis, hyperkalemia, etc. Additionally, some new suspicious adverse reactions were discovered, such as jaundice, hyperbilirubinemia, retinal hemorrhage, etc. Conclusion In clinical practice, healthcare professionals should pay attention to patients' thyroid function indicators, cardiovascular and cerebrovascular function, blood potassium levels, as well as infection symptoms and signs, and be alter to the adverse event signals not mentioned in the instruction to ensure patient safety.

R973