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质子泵抑制剂相关急性肾损伤和慢性肾脏病:美国 FDA 不良事件报告系统的数据挖掘。

Proton pump inhibitors associated acute kidney injury and chronic kidney disease: data mining of US FDA adverse event reporting system.

机构信息

Department of Pharmacy, West China Hospital, Sichuan University, 37 Guoxue Alley, Wuhou, Chengdu, 610041, Sichuan, China.

West China School of Medicine, Sichuan University, Chengdu, 610041, Sichuan, China.

出版信息

Sci Rep. 2021 Feb 11;11(1):3690. doi: 10.1038/s41598-021-83099-y.

Abstract

Proton pump inhibitors (PPIs) were widely used. Observational studies suggested increasing risk of kidney injury in patients with PPIs treatment. We gathered six PPI regimens and adverse reports of acute kidney injury (AKI) and chronic kidney disease (CKD) based on US FDA Adverse Event Reporting System (FAERS) database from 2004 to 2019. We employed reporting odds ratio (ROR) to detect signals. Finally, we identified 3187 PPIs-associated AKI cases and 3457 PPIs-associated CKD cases. We detected significant signals between PPIs and AKI as well as CKD. The signal strength was stronger for CKD (ROR = 8.80, 95% CI 8.49-9.13) than AKI (ROR = 3.95, 95% CI 3.81-4.10), while dexlansoprazole performed stronger association for CKD (ROR = 34.94, 95% CI 30.89-39.53) and AKI (ROR = 8.18, 95% CI 7.04-9.51) than the other five PPIs. The median time from PPIs use to event occurrence was 23 days for AKI and 177 days for CKD. PPIs-associated AKI resulted larger proportion of death, life-threatening, hospitalization and disability events than PPIs-associated CKD. By mining the FAERS big data, we provided more information between PPIs use and the AKI and CKD events. PPIs rational use should be repeatedly stressed.

摘要

质子泵抑制剂(PPIs)被广泛应用。观察性研究表明,PPIs 治疗的患者发生肾脏损伤的风险增加。我们从 2004 年至 2019 年,基于美国食品药品监督管理局不良事件报告系统(FAERS)数据库,收集了六种 PPI 方案和 PPI 治疗导致的急性肾损伤(AKI)和慢性肾脏病(CKD)的不良报告。我们采用报告比值比(ROR)来检测信号。最终,我们确定了 3187 例与 PPI 相关的 AKI 病例和 3457 例与 PPI 相关的 CKD 病例。我们检测到 PPI 与 AKI 和 CKD 之间存在显著信号。与 AKI 相比,CKD 的信号强度更强(ROR=8.80,95%CI 8.49-9.13),而达克普隆(dexlansoprazole)与 CKD(ROR=34.94,95%CI 30.89-39.53)和 AKI(ROR=8.18,95%CI 7.04-9.51)的关联更强。从 PPI 使用到事件发生的中位时间为 AKI 23 天,CKD 177 天。与 PPI 相关的 AKI 导致的死亡、危及生命、住院和残疾事件的比例大于与 PPI 相关的 CKD。通过挖掘 FAERS 大数据,我们提供了更多关于 PPI 使用与 AKI 和 CKD 事件之间的信息。应反复强调 PPI 的合理使用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/15c1/7878877/26f75ab887c9/41598_2021_83099_Fig1_HTML.jpg

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