目的 通過分析美國食品藥品監(jiān)督管理局不良事件報告系統(tǒng)（FAERS）數(shù)據(jù)庫，挖掘萬古霉素在老年患者的不良事件（ADE），為臨床用藥監(jiān)護提供參考。方法 收集FAERS數(shù)據(jù)庫從2004年至2022年第1季度的ADE報告，使用Open Vigil 2.1數(shù)據(jù)平臺，對65歲以上患者使用萬古霉素的ADE進行預處理。采用報告比值比（ROR）法和比例報告比值比（PRR）法對ADE進行挖掘與分析，獲得發(fā)生頻次及信號強度前10位的ADE，并分析前10位的聯(lián)合用藥情況。結果 以萬古霉素為首要懷疑藥品在65歲以上人群中的ADE報告共2221份，檢測到ADE信號2194個，其中445個屬于藥物的不良反應。按照發(fā)生頻次排序，ADE分別為藥物超敏反應（313例）、急性腎損傷（301例）及發(fā)熱（296例）等。按照信號強度排序，ADE分別為禽流感（ROR＝4312.79）、細菌性心包炎（ROR＝2985.78）及假絲酵母菌腦膜炎（ROR＝1658.77）。聯(lián)合用藥中，前3位的藥物分別為哌拉西林/他唑巴坦151例，慶大霉素119例及美羅培南112例。結論 萬古霉素在老年人應用時，應警惕腎毒性、超敏反應及谷濃度，同時應注意聯(lián)合用藥對萬古霉素不良反應發(fā)生的影響。

Objective To analyze the adverse drug event (ADE) of vancomycin in elderly patients by analyzing the FDA Adverse Event Reporting System (FAERS) database and provide reference for clinical medication monitoring. Methods ADE reports were collected from the FAERS database from 2004 to the first quarter of 2022, and ADE with vancomycin use in>65 years of age were preprocessed using the OpenVigil 2.1. Reporting odds ratio (ROR) method and proportional reporting ratio (PRR) method were used to mine and analyze ADE. The top 10 ADE in frequency and signal intensity were obtained, and the top 10 combination drugs were analyzed. Results There were 2 221 ADE reports of vancomycin as the primary suspected drug in the population over 65 years old, and 2194 ADE signals were detected, of which 445 were adverse drug reactions. According to the order of frequency of occurrence, ADE were drug hypersensitivity (n = 313), acute kidney injury (n = 301) and fever (n = 296). According to the signal intensity ranking, ADE were avian influenza (ROR = 4312.79), bacterial pericarditis (ROR = 2985.78) and candida meningitis (ROR = 1658.77). Among the combination drugs, the top three drugs were piperacillin/tazobactam in 151 cases, gentamicin in 119 cases and meloxicam in 112 cases. Conclusion Vancomycin should be alert to nephrotoxicity, hypersensitivity and trough concentration in the elderly, and attention should be paid to the effect of combination therapy on the occurrence of adverse reactions of vancomycin.

鄂爾多斯市財政資助醫(yī)學重點學科建設項目（鄂衛(wèi)健發(fā)〔2020〕230號）