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氟喹诺酮类药物与磺酰脲类药物使用者严重低血糖风险的关系:基于人群的队列研究。

Fluoroquinolones and the risk of severe hypoglycaemia among sulphonylurea users: Population-based cohort study.

机构信息

Department of Medicine, McGill University, Montreal, Canada.

Centre for Clinical Epidemiology, Lady Davis Institute, Montreal, Canada.

出版信息

Diabetes Obes Metab. 2024 Aug;26(8):3088-3098. doi: 10.1111/dom.15627. Epub 2024 May 2.

DOI:10.1111/dom.15627
PMID:38698651
Abstract

AIM

Fluoroquinolone-related hypoglycaemia is rare but may become clinically relevant in individuals at high baseline hypoglycaemic risk, such as patients with diabetes using sulphonylureas. Our population-based cohort study assessed whether fluoroquinolones are associated with an increased risk of severe hypoglycaemia compared with amoxicillin among patients treated with sulphonylureas.

MATERIALS AND METHODS

Using the UK's Clinical Practice Research Datalink Aurum linked to hospitalization and vital statistics data, we assembled a base cohort of patients who initiated second-generation sulphonylureas (1998-2020). The study cohort included patients initiating either fluoroquinolones or amoxicillin while on sulphonylureas. Using an intent-to-treat exposure definition, we assessed the 30-day risk of severe hypoglycaemia (hospitalization with or death because of hypoglycaemia) associated with fluoroquinolones compared with amoxicillin. Cox models estimated hazard ratios (HRs) with 95% confidence intervals (CIs) of severe hypoglycaemia after 1:5 matching on previous sulphonylurea use and propensity scores. Secondary analyses were stratified by demographics and glycated haemoglobin.

RESULTS

Overall, 143 417 patients initiated fluoroquinolones (n = 13 123) or amoxicillin (n = 130 294) while on sulphonylureas. Compared with amoxicillin, fluoroquinolones were not associated with the risk of severe hypoglycaemia (HR, 1.17; 95% CI, 0.91-1.50). Fluoroquinolones were associated with an increased risk in patients <65 years (HR, 2.90; 95% CI, 1.41-5.97) but not in those ≥65 years (HR, 1.03; 95% CI, 0.79-1.35) in stratified analyses. There was no evidence of effect modification by sex or glycated haemoglobin.

CONCLUSIONS

In patients using second-generation sulphonylureas, fluoroquinolones were not associated with an increased risk of severe hypoglycaemia compared with amoxicillin. An increased risk among younger adults is possible.

摘要

目的

氟喹诺酮类药物相关低血糖症较为罕见,但对于基线低血糖风险较高的个体(如正在使用磺酰脲类药物的糖尿病患者),可能具有重要的临床意义。我们的基于人群的队列研究评估了与使用磺酰脲类药物的患者相比,氟喹诺酮类药物是否与严重低血糖风险增加相关。

材料和方法

我们使用英国临床实践研究数据链 Aurum,将其与住院和生命统计数据相关联,组建了一个使用第二代磺酰脲类药物的基础队列(1998-2020 年)。研究队列包括开始使用氟喹诺酮类药物或阿莫西林的患者。使用意向治疗暴露定义,我们评估了氟喹诺酮类药物与阿莫西林相比,与 30 天严重低血糖(因低血糖住院或死亡)风险的关系。Cox 模型使用以前使用磺酰脲类药物和倾向评分进行 1:5 匹配后,估计严重低血糖的风险比(HR)及其 95%置信区间(CI)。次要分析按人口统计学和糖化血红蛋白分层。

结果

总体而言,143417 名患者开始使用氟喹诺酮类药物(n=13123)或阿莫西林(n=130294)的同时使用磺酰脲类药物。与阿莫西林相比,氟喹诺酮类药物与严重低血糖风险无关(HR,1.17;95%CI,0.91-1.50)。在年龄<65 岁的患者中,氟喹诺酮类药物与风险增加相关(HR,2.90;95%CI,1.41-5.97),但在年龄≥65 岁的患者中无此相关性(HR,1.03;95%CI,0.79-1.35)。性别或糖化血红蛋白无明显的交互作用。

结论

在使用第二代磺酰脲类药物的患者中,与阿莫西林相比,氟喹诺酮类药物与严重低血糖风险无关。年轻患者的风险可能增加。

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