目的 分析探究泊沙康唑的不良事件（ADE）信號(hào)，為臨床合理用藥提供數(shù)據(jù)支持。方法 利用美國食品藥品監(jiān)督管理局不良事件呈報(bào)系統(tǒng)（FAERS）進(jìn)行數(shù)據(jù)挖掘，分別應(yīng)用報(bào)告比值比法（ROR）和比例報(bào)告比值比法（PRR）對泊沙康唑的不良事件信號(hào)進(jìn)行分析研究。結(jié)果 泊沙康唑ADE多見于各類檢查、肝膽系統(tǒng)、內(nèi)分泌系統(tǒng)、胃腸系統(tǒng)。發(fā)現(xiàn)胰腺炎，麻痹性腸梗阻等ADE在該藥品說明書中未見闡述。分別篩選出血藥濃度變化、假性醛固酮增多癥、胰腺炎、肝臟及心臟相關(guān)不良事件發(fā)生的危險(xiǎn)因素。結(jié)論 應(yīng)用該藥前應(yīng)詳細(xì)評估患者的危險(xiǎn)因素，并針對性進(jìn)行相應(yīng)不良事件的重點(diǎn)監(jiān)測。

Objective To analyze the adverse event signal of posaconazole to provide data support for clinical rational drug use. Methods The adverse event signal of posaconazole was analyzed by ROR and PRR using data mining of the FAERS. Results Posaconazole ADE is more common in various examinations, hepatobiliary system, endocrine system, gastrointestinal system. It was found that ADE such as pancreatitis and paralytic intestinal obstruction were not described in the drug instructions. The risk factors of hemorrhagic drug concentration change, pseudoaldosteronism, pancreatitis, liver and heart related adverse events were screened. Conclusion Before the use of this drug, the risk factors of patients should be evaluated in detail, and the corresponding adverse events should be monitored.

R978.1

天津市衛(wèi)生健康委青年人才項(xiàng)目（TJWJ2021QN057）；天津市醫(yī)學(xué)重點(diǎn)學(xué)科（?？疲┙ㄔO(shè)項(xiàng)目（TJYXZDXK-049A）