摘要
目的建立主动监测规则,挖掘伏立康唑所致精神障碍和视觉异常的病例,分析其临床特征及相关影响因素。方法应用中国医院药物警戒系统(CHPS)的药品评价功能,监测2021年1月1日至2024年12月31日在厦门大学附属第一医院使用伏立康唑治疗的住院患者,挖掘发生精神障碍和视觉异常不良反应(ADR)的阳性病例,纳入研究对象的临床资料及实验室结果,包括性别、年龄、用药信息、6项实验室指标等,应用巢式病例对照研究(NCCS)方法以入院前后一周为匹配条件分组,运用χ^(2)检验和Mann-Whitney U检验对其进行单因素分析,对有意义的结果纳入多因素logistic回归分析,确定伏立康唑所致精神异常和视觉障碍的的独立影响因素。结果监测模型预警病例317例次,经药师筛选后确定发生目标ADR的阳性病例45例,监测模型的阳性发现率为14.2%。静脉滴注[3.03(1.25~7.31)]、联合使用莫西沙星[4.66(1.56~13.96)]、联合使用奥美拉唑[2.42(1.02~5.71)]、高维持剂量[1.01(1.01~1.01)]、总胆红素偏高[1.06(1.02~1.11)]是伏立康唑致精神障碍和视觉异常的独立危险因素。结论应用CHPS系统主动监测伏立康唑致精神障碍和视觉异常相关ADR具有良好可行性,该ADR多发生在用药后的1~9d,联合莫西沙星或奥美拉唑、静脉滴注给药、维持剂量高和用药前总胆红素水平高更易发生,应尽量避免上述因素以降低发生率。
OBJECTIVE To establish active surveillance criteria for identifying cases of psychiatric abnormali-ties and visual disturbances associated with voriconazole,and to analyze their clinical characteristics and contributing factors.METHODS Using the drug evaluation module of the Chinese Hospital Pharmacovigilance System(CHPS),this study monitored hospitalized patients receiving voriconazole treatment at the our hospital from January 1,2021 to December 31,2024.Cases with confirmed adverse drug reactions(ADR)involving psychiatric or visual abnormalities were identified as positive cases.Clinical data and laboratory parameters,including gender,age,medication details,and six laboratory indices,were collected.A nested case-control study(NCCS)was conducted with groups matched based on a one-week interval before and after hospitalization.Univariate analysis using theχ^(2)test and Mann-Whitney U test was performed,followed by multivariate logistic regression to identify independent risk factors for voriconazole-induced psychiatric and visual abnormalities.RESULTS Among 317 cases flagged by the surveillance model,45 positive cases of target ADR were confirmed after pharmacist review,yielding a positive detection rate of 14.2%.Independent risk factors included intravenous administration[OR=3.03,95%CI:1.25-7.31],concomitant use of moxifloxacin[OR=4.66,95%CI:1.56-13.96],concomitant use of omeprazole[OR=2.42,95%CI:1.02-5.71],high maintenance dose[OR=1.01,95%CI:1.01-1.01],and elevated total bilirubin levels[OR=1.06,95%CI:1.02-1.11].CONCLUSION Active surveillance of voriconazole-related psychiatric and visual ADRs using the CHPS system demonstrates practical feasibility.These ADRs predominantly manifest within 1-9 days of treatment initiation.Risk factors such as concomitant use of moxifloxacin or omeprazole,intravenous administra-tion,high maintenance doses,and elevated baseline total bilirubin levels should be minimized to reduce incidence.
作者
刘宏尉
吴艺燕
王渊
林艺聪
LIU Hong-wei;WU Yi-yan;WANG yuan;LIN Yi-cong(Department of Pharmacy,The First Affiliated Hospital of Xiamen University,Xiamen 361000,China)
出处
《海峡药学》
2025年第12期138-142,共5页
Strait Pharmaceutical Journal
关键词
伏立康唑
药物警戒
精神异常
不良反应
Voriconazole
Pharmacovigilance
Psychiatric Disorders
Adverse Drug Reactions
