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质子泵抑制剂与心肌梗死之间的关联:美国食品药品监督管理局的数据告诉了我们什么?

The Association between Proton Pump Inhibitors and Myocardial Infarction: What Do Food and Drug Administration Data Tell Us?

作者信息

Tan Jiun Ming, Parsons Richard, Sim Tin Fei, Lee Ya Ping

机构信息

School of Pharmacy and Biochemical Sciences, Faculty of Health Sciences, Curtin University, Western Australia.

出版信息

J Res Pharm Pract. 2019 Oct 16;8(3):123-128. doi: 10.4103/jrpp.JRPP_19_73. eCollection 2019 Jul-Sep.

Abstract

OBJECTIVE

There is limited and conflicting evidence on the association between proton pump inhibitors (PPIs) and myocardial infarction (MI). This study aims to examine the occurrence of MI associated with PPI use from the Food and Drug Administration (FDA) Adverse Event Reporting System database.

METHODS

This is a cross-sectional study using data from the FDA dated from December 2013 to April 2018. Standard descriptive statistics were used to describe demographic information. Logistic regression analyses were performed to investigate the association between the independent variables and MI.

FINDINGS

Among the 52,443 individuals who were taking a PPI and experienced an adverse event which was registered on the FDA database, 726 (1.38%) experienced MI. Of all the PPIs, esomeprazole had the largest proportion of users experiencing MI (1.81%). Compared to other PPIs, esomeprazole was associated with a significantly higher rate of MI (odds ratio [OR] =1.53, < 0.001), whereas lansoprazole was associated with a lower rate of MI (OR = 0.74, = 0.03).

CONCLUSION

Among the PPIs, esomeprazole appeared to have the highest risk of MI. Although the observed associations do not infer causality, this study highlighted a need for further studies to determine if a PPI, especially esomeprazole, can indeed cause MI.

摘要

目的

关于质子泵抑制剂(PPI)与心肌梗死(MI)之间的关联,证据有限且相互矛盾。本研究旨在通过美国食品药品监督管理局(FDA)不良事件报告系统数据库,调查与使用PPI相关的MI的发生情况。

方法

这是一项横断面研究,使用了FDA在2013年12月至2018年4月期间的数据。采用标准描述性统计来描述人口统计学信息。进行逻辑回归分析以研究自变量与MI之间的关联。

结果

在52443名正在服用PPI且经历了在FDA数据库中登记的不良事件的个体中,726人(1.38%)发生了MI。在所有PPI中,埃索美拉唑使用人群中发生MI的比例最高(1.81%)。与其他PPI相比,埃索美拉唑与显著更高的MI发生率相关(优势比[OR]=1.53,<0.001),而兰索拉唑与较低的MI发生率相关(OR=0.74,=0.03)。

结论

在PPI中,埃索美拉唑似乎具有最高的MI风险。尽管观察到的关联并不意味着因果关系,但本研究强调需要进一步研究以确定PPI,尤其是埃索美拉唑,是否确实会导致MI。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6dd2/6830015/77fecb7add18/JRPP-8-123-g001.jpg

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