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糖尿病患者的药物警戒:一项数据驱动的分析,确定了具有不良肺部安全性特征的特定 RAS 拮抗剂,这些特征对 COVID-19 的发病率和死亡率有影响。

Pharmacovigilance in patients with diabetes: A data-driven analysis identifying specific RAS antagonists with adverse pulmonary safety profiles that have implications for COVID-19 morbidity and mortality.

出版信息

J Am Pharm Assoc (2003). 2020 Nov-Dec;60(6):e145-e152. doi: 10.1016/j.japh.2020.05.018. Epub 2020 Jun 1.

Abstract

OBJECTIVES

The current demographic information from China reports that 10%-19% of patients hospitalized with coronavirus disease (COVID-19) were diabetic. Angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin II receptor blockers (ARBs) are considered first-line agents in patients with diabetes because of their nephroprotective effects, but administration of these drugs leads to upregulation of angiotensin-converting enzyme 2 (ACE2), which is responsible for the viral entry of severe acute respiratory distress syndrome coronavirus 2 (SARS-CoV-2). Data are lacking to determine what pulmonary effects ACEIs or ARBs may have in patients with diabetes, which could be relevant in the management of patients infected with SARS-CoV-2. This study aims to assess the prevalence of pulmonary adverse drug effects (ADEs) in patients with diabetes who were taking ACEI or ARBs to provide guidance as to how these medications could affect outcomes in acute respiratory illnesses such as SARS-CoV-2 infection.

METHODS

1DATA, a unique data platform resulting from collaboration across veterinary and human health care, used an intelligent medicine recommender system (1DrugAssist) developed using several national and international databases to evaluate all ADEs reported to the Food and Drug Administration for patients with diabetes taking ACEIs or ARBs.

RESULTS

Mining of this data elucidated the proportion of a cluster of pulmonary ADEs associated with specific medications in these classes, which may aid health care professionals in understanding how these medications could worsen or predispose patients with diabetes to infections affecting the respiratory system, specifically COVID-19. Based on this data mining process, captopril was found to have a statistically significantly higher incidence of pulmonary ADEs compared with other ACEIs (P = 0.005) as well as ARBs (P = 0.012), though other specific drugs also had important pulmonary ADEs associated with their use.

CONCLUSION

These analyses suggest that pharmacists and clinicians will need to consider the specific medication's adverse event profile, particularly captopril, on how it may affect infections and other acute disease states that alter pulmonary function, such as COVID-19.

摘要

目的

目前中国的人口统计数据报告显示,住院的冠状病毒病(COVID-19)患者中有 10%-19%患有糖尿病。血管紧张素转换酶抑制剂(ACEI)和血管紧张素 II 受体阻滞剂(ARB)因其具有肾脏保护作用而被认为是糖尿病患者的一线药物,但这些药物的使用会导致血管紧张素转换酶 2(ACE2)的上调,ACE2 负责严重急性呼吸窘迫综合征冠状病毒 2(SARS-CoV-2)的病毒进入。目前尚无数据确定 ACEI 或 ARB 在糖尿病患者中可能产生的肺部不良反应,这在管理感染 SARS-CoV-2 的患者时可能很重要。本研究旨在评估服用 ACEI 或 ARB 的糖尿病患者肺部不良反应(ADE)的发生率,为这些药物在 SARS-CoV-2 感染等急性呼吸道疾病中的作用提供指导。

方法

1DATA 是兽医和人类医疗保健合作产生的独特数据平台,使用了一个使用多个国家和国际数据库开发的智能药物推荐系统(1DrugAssist)来评估向美国食品和药物管理局报告的所有糖尿病患者服用 ACEI 或 ARB 的 ADE。

结果

对这些数据的挖掘阐明了与这些类别中的特定药物相关的肺部 ADE 集群的比例,这可能有助于医疗保健专业人员了解这些药物如何使糖尿病患者的病情恶化或易感染影响呼吸系统的感染,特别是 COVID-19。基于此数据挖掘过程,发现卡托普利与其他 ACEI(P = 0.005)和 ARB(P = 0.012)相比,发生肺部 ADE 的发生率具有统计学意义更高,尽管其他特定药物也与使用相关的重要肺部 ADE。

结论

这些分析表明,药剂师和临床医生将需要考虑特定药物的不良事件概况,特别是卡托普利,因为它可能会影响感染和其他改变肺功能的急性疾病状态,例如 COVID-19。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/61c6/7262497/12e80ad8791d/gr1_lrg.jpg

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