目的 通过分析美国食品药品监督管理局不良事件报告系统（FAERS）数据库，挖掘万古霉素在老年患者的不良事件（ADE），为临床用药监护提供参考。方法 收集FAERS数据库从2004年至2022年第1季度的ADE报告，使用Open Vigil 2.1数据平台，对65岁以上患者使用万古霉素的ADE进行预处理。采用报告比值比（ROR）法和比例报告比值比（PRR）法对ADE进行挖掘与分析，获得发生频次及信号强度前10位的ADE，并分析前10位的联合用药情况。结果 以万古霉素为首要怀疑药品在65岁以上人群中的ADE报告共2221份，检测到ADE信号2194个，其中445个属于药物的不良反应。按照发生频次排序，ADE分别为药物超敏反应（313例）、急性肾损伤（301例）及发热（296例）等。按照信号强度排序，ADE分别为禽流感（ROR＝4312.79）、细菌性心包炎（ROR＝2985.78）及假丝酵母菌脑膜炎（ROR＝1658.77）。联合用药中，前3位的药物分别为哌拉西林/他唑巴坦151例，庆大霉素119例及美罗培南112例。结论 万古霉素在老年人应用时，应警惕肾毒性、超敏反应及谷浓度，同时应注意联合用药对万古霉素不良反应发生的影响。

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.

鄂尔多斯市财政资助医学重点学科建设项目（鄂卫健发〔2020〕230号）