摘要
目的基于美国FDA不良事件报告系统(FAERS)数据库,评估不同喹诺酮类药物与全血细胞减少症的关联性,以识别潜在风险信号。方法提取FAERS数据库中全血细胞减少症病例报告,采用报告比值比(ROR)、比例报告比值比(PRR)及贝叶斯置信传播神经网络(信息组分,IC)三种不相称性分析方法进行数据挖掘,并利用χ^(2)检验评估关联的统计学意义。结果共纳入46,715例报告,其中249例(0.53%)与喹诺酮类药物相关。风险信号分析显示,不同喹诺酮类药物风险存在异质性:氧氟沙星(ROR=2.27,95%CI:1.31-3.90)和诺氟沙星(ROR=3.13,95%CI:1.01-9.72)显示出显著的正向风险信号;而环丙沙星、左氧氟沙星、莫西沙星和加替沙星则未检测到显著信号。卡方检验进一步证实氧氟沙星、诺氟沙星、左氧氟沙星和莫西沙星的关联具有显著性(P<0.05)。结论在喹诺酮类药物中,氧氟沙星和诺氟沙星与全血细胞减少症的关联风险信号较强,提示临床使用这些药物时应加强血液学监测。本研究为喹诺酮类药物的安全性差异提供了真实世界证据。
OBJECTIVE To evaluate the association between different fluoroquinolones and pancytopenia and identify potential risk signals based on the USA FDA Adverse Event Reporting System(FAERS)database.METHODS Case reports of pancytopenia were extracted from the FAERS database.Disproportionality analysis was performed using the Reporting Odds Ratio(ROR),Proportional Reporting Ratio(PRR),and Bayesian Confidence Propagation Neural Network(Information Component,IC)methods.The Chi-square test was used to assess statistical significance.RESULTS A total of 46,715 reports were included,of which 249(0.53%)were associated with fluoroquinolone use.Risk analysis revealed heterogeneity among different drugs:ofloxacin(ROR=2.27,95%CI:1.31-3.90)and norfloxacin(ROR=3.13,95% CI:1.01-9.72)showed significant positive risk signals.In contrast,no significant signals were detected for ciprofloxacin,levofloxacin,moxifloxacin,or gatifloxacin.The Chi-square test further confirmed significant associations(P<0.05)for ofloxacin,norfloxacin,levofloxacin,and moxifloxacin.CONCLUSION Among fluoroquinolones,ofloxacin and norfloxacin show stronger risk signals associated with pancytopenia,suggesting that enhanced hematological monitoring may be warranted during their clinical use.This study provides real-world evidence on the safety differences among fluoroquinolone antibiotics.
作者
卢贞
高沁
LU Zhen;GAO Qin(Jinshan Campus,Provincial Hospital Affiliated to Fuzhou University,Fuzhou 350028,China;People's Hospital Affiliated to Fujian University of Traditional Chinese Medicine,Fuzhou 350004,China)
出处
《海峡药学》
2025年第12期129-133,共5页
Strait Pharmaceutical Journal
