Abstract：
OBJECTIVE: Metronidazole, a widely used antimicrobial medication, has been linked to neurologic adverse drug reactions. This study investigates the association between metronidazole use and first-time neurologic events.
METHODS: We conducted a case-time-control study using data from the Danish National Patient Register and the National Prescription Register in years 2013 to 2021. Patients with a first-time diagnosis of encephalopathy, cerebellar dysfunction, or peripheral neuropathy were included. Conditional logistic regression analyses were performed to estimate the risk of neurologic events associated with metronidazole use.
RESULTS: Out of 476,066 first-time metronidazole prescriptions, the 100-day cumulative incidence of peripheral neuropathy was 0.016%, and 0.002% for cerebellar dysfunction or encephalopathy. In the case-time control study, we identified 17,667 persons with a first-time neurologic event and were included for the analysis. The estimated odds ratio for the combined neurologic events was 0.98 (95% CI, 0.59-1.64, P = 0.95) with no statistically significant association across different subgroups and time windows.
CONCLUSIONS: Our findings suggest that metronidazole-induced neurologic events may be rarer than previously described, and we did not find any consistent or statistically significant association between metronidazole exposure. Nonetheless, clinicians should remain vigilant to potential neurologic risks in patients receiving metronidazole, to ensure its safe and effective use.
METHODS: We conducted a case-time-control study using data from the Danish National Patient Register and the National Prescription Register in years 2013 to 2021. Patients with a first-time diagnosis of encephalopathy, cerebellar dysfunction, or peripheral neuropathy were included. Conditional logistic regression analyses were performed to estimate the risk of neurologic events associated with metronidazole use.
RESULTS: Out of 476,066 first-time metronidazole prescriptions, the 100-day cumulative incidence of peripheral neuropathy was 0.016%, and 0.002% for cerebellar dysfunction or encephalopathy. In the case-time control study, we identified 17,667 persons with a first-time neurologic event and were included for the analysis. The estimated odds ratio for the combined neurologic events was 0.98 (95% CI, 0.59-1.64, P = 0.95) with no statistically significant association across different subgroups and time windows.
CONCLUSIONS: Our findings suggest that metronidazole-induced neurologic events may be rarer than previously described, and we did not find any consistent or statistically significant association between metronidazole exposure. Nonetheless, clinicians should remain vigilant to potential neurologic risks in patients receiving metronidazole, to ensure its safe and effective use.
摘要：
目标：甲硝唑，一种广泛使用的抗菌药物，与神经系统药物不良反应有关。这项研究调查了甲硝唑使用与首次神经系统事件之间的关联。
方法：我们在2013年至2021年期间使用来自丹麦国家患者登记册和国家处方登记册的数据进行了病例时间对照研究。首次诊断为脑病的患者，小脑功能障碍,或包括周围神经病变。进行条件逻辑回归分析以评估与甲硝唑使用相关的神经系统事件的风险。
结果：在476,066次首次甲硝唑处方中，周围神经病变的100天累积发生率为0.016%，和0.002％为小脑功能障碍或脑病。在病例时间对照研究中，我们确定了17,667人首次出现神经系统事件,并纳入分析.合并神经系统事件的估计比值比为0.98（95％CI，0.59-1.64，P=0.95），在不同的亚组和时间窗口之间没有统计学上的显着关联。
结论：我们的研究结果表明，甲硝唑引起的神经系统事件可能比以前描述的更罕见，我们没有发现甲硝唑暴露之间有任何一致或统计学显著的关联.尽管如此，临床医生应该对接受甲硝唑的患者的潜在神经系统风险保持警惕，以确保其安全有效的使用。
方法：我们在2013年至2021年期间使用来自丹麦国家患者登记册和国家处方登记册的数据进行了病例时间对照研究。首次诊断为脑病的患者，小脑功能障碍,或包括周围神经病变。进行条件逻辑回归分析以评估与甲硝唑使用相关的神经系统事件的风险。
结果：在476,066次首次甲硝唑处方中，周围神经病变的100天累积发生率为0.016%，和0.002％为小脑功能障碍或脑病。在病例时间对照研究中，我们确定了17,667人首次出现神经系统事件,并纳入分析.合并神经系统事件的估计比值比为0.98（95％CI，0.59-1.64，P=0.95），在不同的亚组和时间窗口之间没有统计学上的显着关联。
结论：我们的研究结果表明，甲硝唑引起的神经系统事件可能比以前描述的更罕见，我们没有发现甲硝唑暴露之间有任何一致或统计学显著的关联.尽管如此，临床医生应该对接受甲硝唑的患者的潜在神经系统风险保持警惕，以确保其安全有效的使用。
