Li Dongxuan, Song Yi, Bai Zhanfeng, Xi Xin, Liu Feng, Zhang Yang, Qin Chunmeng, Du Dan, Du Qian, Liu Songqing
Department of Pharmacy, The Third Affiliated Hospital of Chongqing Medical University, Chongqing 401120, China.
College of Pharmacy, Chongqing Medical University, Chongqing 400016, China.
Antibiotics (Basel). 2023 Jun 27;12(7):1109. doi: 10.3390/antibiotics12071109.
Antibacterial drug exposure (ADE) is a well-known potential risk factor for infection (CDI), but it remains controversial which certain antibacterial drugs are associated with the highest risk of CDI occurrence. To summarize CDI risk associated with ADE, we reviewed the CDI reports related to ADE in the FDA Adverse Event Reporting System database and conducted disproportionality analysis to detect adverse reaction (ADR) signals of CDI for antibacterial drugs. A total of 8063 CDI reports associated with ADE were identified, which involved 73 antibacterial drugs. Metronidazole was the drug with the greatest number of reports, followed by vancomycin, ciprofloxacin, clindamycin and amoxicillin. In disproportionality analysis, metronidazole had the highest positive ADR signal strength, followed by vancomycin, cefpodoxime, ertapenem and clindamycin. Among the 73 antibacterial drugs, 58 showed at least one positive ADR signal, and ceftriaxone was the drug with the highest total number of positive signals. Our study provided a real-world overview of CDI risk for AED from a pharmacovigilance perspective and showed risk characteristics for different antibacterial drugs by integrating its positive-negative signal distribution. Meanwhile, our study showed that the CDI risk of metronidazole and vancomycin may be underestimated, and it deserves further attention and investigation.
抗菌药物暴露（ADE）是艰难梭菌感染（CDI）的一个众所周知的潜在风险因素，但某些抗菌药物与CDI发生的最高风险相关仍存在争议。为了总结与ADE相关的CDI风险，我们回顾了美国食品药品监督管理局（FDA）不良事件报告系统数据库中与ADE相关的CDI报告，并进行了不成比例分析，以检测抗菌药物CDI的不良反应（ADR）信号。共识别出8063份与ADE相关的CDI报告，涉及73种抗菌药物。甲硝唑报告数量最多，其次是万古霉素、环丙沙星、克林霉素和阿莫西林。在不成比例分析中，甲硝唑的ADR阳性信号强度最高，其次是万古霉素、头孢泊肟、厄他培南和克林霉素。在这73种抗菌药物中，58种显示至少一个阳性ADR信号，头孢曲松是阳性信号总数最高的药物。我们的研究从药物警戒角度提供了AED的CDI风险的真实情况概述，并通过整合其正负信号分布显示了不同抗菌药物的风险特征。同时，我们的研究表明，甲硝唑和万古霉素的CDI风险可能被低估，值得进一步关注和调查。
