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氟喹诺酮类药物的使用与孔源性视网膜脱离风险:一项使用两个全国代表性索赔数据库的回顾性队列研究。

Use of fluoroquinolones and risk of rhegmatogenous retinal detachment: a retrospective cohort study using two nationwide representative claims databases.

作者信息

Lin Ting-Yu, Wang Jiun-Ling, Wang Grace Hsin-Min, Huang Yu-Yun, Chen Ming-Ching, Dong Yaa-Hui, Lo-Ciganic Wei-Hsuan

机构信息

Department of Pharmacy, College of Pharmaceutical Sciences, National Yang Ming Chiao Tung University, Taipei, Taiwan.

Department of Pharmacy Administration, Chang Gung Medical Foundation, Taoyuan City, Taiwan.

出版信息

Front Pharmacol. 2024 Dec 11;15:1414221. doi: 10.3389/fphar.2024.1414221. eCollection 2024.

Abstract

BACKGROUND

Although biological plausibility suggests that fluoroquinolones could lead to rhegmatogenous retinal detachment (RRD) through collagen degradation, real-world evidence on their relative risk of RRD is inconsistent, with limited information on absolute risk estimates.

OBJECTIVE

The study aimed to estimate the RRD risk associated with fluoroquinolones versus other antibiotics with similar indications (i.e., comparison antibiotics).

METHODS

We conducted a retrospective cohort study analyzing claims data from adult patients who initiated fluoroquinolones or amoxicillin/clavulanate or ampicillin/sulbactam or extended-spectrum cephalosporins using the Taiwan National Health Insurance Research Database (2009-2018) and the United States IBM MarketScan Database (2011-2020). Patients were followed for up to 90 days after cohort entry. For each country's data, after 1:1 propensity score (PS) matching, we used Cox regression models to estimate RRD risks, presented with hazard ratios (HR) with 95% confidence interval (95% CI). We used random-effects meta-analyses to derive pooled HRs across both counties.

RESULTS

Of 24,172,032 eligible patients comprising 7,944,620 insured Taiwanese (mean age [SD], 46 [18] years; 45% male) and 16,227,412 United States commercially insured individuals (mean age [SD], 47 [16] years; 40% male), 10,137,468 patients initiated fluoroquinolones, 10,203,794 initiated amoxicillin/clavulanate or ampicillin/sulbactam, and 3,830,770 initiated extended-spectrum cephalosporins. After PS matching, similar RRD incidence rates were observed between fluoroquinolones and amoxicillin/clavulanate or ampicillin/sulbactam users (0.33 [95% CI, 0.19-0.56] versus 0.35 [95% CI, 0.26-0.46] per 1,000 person-years), yielding an HR of 0.97 (95% CI, 0.76-1.23). The RRD incidence rates were also similar comparing fluoroquinolones to extended-spectrum cephalosporins (0.36 [95% CI, 0.22-0.57] versus 0.34 [95% CI, 0.22-0.50] per 1,000 person-years; HR, 1.08 [95% CI, 0.92-1.27]). The comparative safety profiles remained consistent by country, various patient characteristic (e.g., diabetes or ophthalmic conditions), type of fluoroquinolones, follow-up duration, or treatment setting.

CONCLUSION

This large-scale study, leveraging real-world data from Taiwan and the United States, showed a low and comparable RRD risk among adults who initiated fluoroquinolones or other antibiotics with similar indications. This suggests that the RRD risk should not deter the use of fluoroquinolone when clinically indicated.

摘要

背景

尽管从生物学合理性来看,氟喹诺酮类药物可能通过胶原蛋白降解导致孔源性视网膜脱离(RRD),但关于其导致RRD的相对风险的实际证据并不一致,且绝对风险估计信息有限。

目的

本研究旨在评估氟喹诺酮类药物与具有相似适应证的其他抗生素(即对照抗生素)相比的RRD风险。

方法

我们进行了一项回顾性队列研究,利用台湾国民健康保险研究数据库(2009 - 2018年)和美国IBM MarketScan数据库(2011 - 2020年)分析成年患者开始使用氟喹诺酮类药物、阿莫西林/克拉维酸、氨苄西林/舒巴坦或广谱头孢菌素的索赔数据。队列入组后对患者随访长达90天。对于每个国家的数据,在进行1:1倾向评分(PS)匹配后,我们使用Cox回归模型估计RRD风险,以风险比(HR)及95%置信区间(95%CI)表示。我们使用随机效应荟萃分析得出两个国家的合并HR。

结果

在24172032名符合条件的患者中,包括7944620名台湾参保者(平均年龄[标准差],46[18]岁;45%为男性)和16227412名美国商业保险个体(平均年龄[标准差],47[16]岁;40%为男性),10137468名患者开始使用氟喹诺酮类药物,10203794名患者开始使用阿莫西林/克拉维酸或氨苄西林/舒巴坦,3830770名患者开始使用广谱头孢菌素。PS匹配后,氟喹诺酮类药物使用者与阿莫西林/克拉维酸或氨苄西林/舒巴坦使用者的RRD发病率相似(每1000人年分别为0.33[95%CI,0.19 - 0.56]和0.35[95%CI,0.26 - 0.46]),HR为0.97(95%CI,0.76 - 1.23)。氟喹诺酮类药物与广谱头孢菌素相比,RRD发病率也相似(每1000人年分别为0.36[95%CI,0.22 - 0.57]和0.34[95%CI,0.22 - 0.50];HR,1.08[95%CI,0.92 - 1.27])。不同国家、各种患者特征(如糖尿病或眼科疾病)、氟喹诺酮类药物类型、随访时间或治疗环境下的比较安全性概况保持一致。

结论

这项利用台湾和美国真实世界数据的大规模研究表明,开始使用氟喹诺酮类药物或其他具有相似适应证的抗生素的成年人中,RRD风险较低且相当。这表明在临床有指征时,RRD风险不应妨碍氟喹诺酮类药物的使用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7780/11668581/0f74a6118f11/fphar-15-1414221-g001.jpg

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