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质子泵抑制剂安全性新数据的临床意义

Clinical Implications of Emerging Data on the Safety of Proton Pump Inhibitors.

作者信息

Schnoll-Sussman Felice, Katz Philip O

机构信息

Jay Monahan Center for Gastrointestinal Health, Department of Gastroenterology and Hepatology, Weill Cornell Medicine, Cornell University, New York, NY, USA.

Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA, USA.

出版信息

Curr Treat Options Gastroenterol. 2017 Mar;15(1):1-9. doi: 10.1007/s11938-017-0115-5.

DOI:10.1007/s11938-017-0115-5
PMID:28130652
Abstract

Proton pump inhibitors (PPI) are among the safest class of drugs used by all care providers, including gastroenterologists. They are the mainstay in treatment of acid-related disease, in particular, gastroesophageal reflux disease. Without them, many patients would experience a major decrement in their quality of life. However, no drug is without side effects or adverse events. In the past decade, numerous reports, principally case control studies and meta-analyses, have raised questions about important adverse events related to the use of PPIs. This has affected not only physicians' prescribing habits but patients' concerns about using these medications, particularly long term. Several FDA warnings are listed including those related to long bone fractures, interaction with clopidogrel, enteric infections, and hypomagnesaemia. More recently, concerns regarding PPIs and cardiovascular events have resurfaced as have issues related to kidney disease and dementia. The methodology of these studies allows us to find an association with these events but does not provide us with sufficient evidence to determine causality. In general, the findings of the available studies do not fit with our clinical experience nor is the magnitude of the association sufficient to result in a major change in our practice. Nevertheless, the recent literature has resulted in our careful reevaluation of PPI use across both FDA indications and in general. This article will critically review the literature regarding potential PPI adverse events and attempt to place them in perspective for the practicing physician.

摘要

质子泵抑制剂(PPI)是包括胃肠病学家在内的所有医疗服务提供者使用的最安全的药物类别之一。它们是治疗酸相关疾病,特别是胃食管反流病的主要药物。没有它们,许多患者的生活质量将大幅下降。然而,没有一种药物没有副作用或不良事件。在过去十年中,大量报告,主要是病例对照研究和荟萃分析,对与使用PPI相关的重要不良事件提出了质疑。这不仅影响了医生的处方习惯,也影响了患者对使用这些药物的担忧,尤其是长期使用。美国食品药品监督管理局(FDA)列出了几项警告,包括与长骨骨折、与氯吡格雷的相互作用、肠道感染和低镁血症相关的警告。最近,对PPI与心血管事件的担忧再次出现,与肾脏疾病和痴呆症相关的问题也是如此。这些研究的方法使我们能够发现与这些事件的关联,但没有为我们提供足够的证据来确定因果关系。一般来说,现有研究的结果与我们的临床经验不符,而且关联的程度也不足以导致我们的临床实践发生重大改变。尽管如此,最近的文献促使我们对FDA适应症范围内以及一般情况下PPI的使用进行了仔细的重新评估。本文将批判性地回顾有关PPI潜在不良事件的文献,并试图为执业医生正确看待这些事件。

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Clinical Implications of Emerging Data on the Safety of Proton Pump Inhibitors.质子泵抑制剂安全性新数据的临床意义
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本文引用的文献

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Proton Pump Inhibitors and Risk of Incident CKD and Progression to ESRD.质子泵抑制剂与新发慢性肾脏病及进展至终末期肾病的风险
J Am Soc Nephrol. 2016 Oct;27(10):3153-3163. doi: 10.1681/ASN.2015121377. Epub 2016 Apr 14.
2
Association of Proton Pump Inhibitors With Risk of Dementia: A Pharmacoepidemiological Claims Data Analysis.质子泵抑制剂与痴呆风险的关联:基于药物流行病学索赔数据分析。
JAMA Neurol. 2016 Apr;73(4):410-6. doi: 10.1001/jamaneurol.2015.4791.
3
Proton Pump Inhibitor Use and the Risk of Chronic Kidney Disease.质子泵抑制剂的使用与慢性肾脏病风险
实体器官移植后的骨质流失:器官特异性考虑因素的综述。
Endocrinol Metab (Seoul). 2024 Apr;39(2):267-282. doi: 10.3803/EnM.2024.1939. Epub 2024 Apr 25.
4
Impact of Proton Pump Inhibitors on Kidney Function and Chronic Kidney Disease Progression: A Systematic Review.质子泵抑制剂对肾功能及慢性肾脏病进展的影响:一项系统评价
Cureus. 2023 Dec 3;15(12):e49883. doi: 10.7759/cureus.49883. eCollection 2023 Dec.
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Endoscopic capsule robot-based diagnosis, navigation and localization in the gastrointestinal tract.基于内镜胶囊机器人的胃肠道诊断、导航与定位
Front Robot AI. 2022 Sep 2;9:896028. doi: 10.3389/frobt.2022.896028. eCollection 2022.
6
Efficacy and Safety of Robotic Dor Fundoplication on Severe Gastroesophageal Reflux Disease in Patients With Scleroderma.机器人 Dor 胃底折叠术治疗硬皮病患者重度胃食管反流病的疗效和安全性。
J Investig Med High Impact Case Rep. 2021 Jan-Dec;9:23247096211051211. doi: 10.1177/23247096211051211.
7
Current therapies for gastro-oesophageal reflux in the setting of chronic lung disease: state of the art review.慢性肺病背景下胃食管反流的当前治疗方法:最新综述
ERJ Open Res. 2020 Nov 10;6(4). doi: 10.1183/23120541.00190-2019. eCollection 2020 Oct.
8
Role and safety of fundoplication in esophageal disease and dysmotility syndromes.胃底折叠术在食管疾病和动力障碍综合征中的作用及安全性
J Thorac Dis. 2019 Aug;11(Suppl 12):S1610-S1617. doi: 10.21037/jtd.2019.06.62.
9
The Advantages and Adverse Events Associated With Long-Term Use of Proton Pump Inhibitors.长期使用质子泵抑制剂的益处及不良事件
Gastroenterol Hepatol (N Y). 2018 Oct;14(10):595-597.
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The relationship between proton pump inhibitors and renal disease.质子泵抑制剂与肾脏疾病之间的关系。
J Bras Nefrol. 2018 Jul-Sep;40(3):301-306. doi: 10.1590/2175-8239-jbn-2018-0021. Epub 2018 Jul 10.
JAMA Intern Med. 2016 Feb;176(2):238-46. doi: 10.1001/jamainternmed.2015.7193.
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Daytime intragastric acid control: post hoc analyses of esomeprazole 20 mg and over-the-counter proton-pump inhibitors.日间胃内酸控制:埃索美拉唑20毫克与非处方质子泵抑制剂的事后分析
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Open Heart. 2015 Jun 30;2(1):e000248. doi: 10.1136/openhrt-2015-000248. eCollection 2015.
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Gastroenterology. 2015 Oct;149(4):883-5.e9. doi: 10.1053/j.gastro.2015.06.043. Epub 2015 Jul 9.
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Proton Pump Inhibitor Usage and the Risk of Myocardial Infarction in the General Population.质子泵抑制剂的使用与普通人群心肌梗死风险
PLoS One. 2015 Jun 10;10(6):e0124653. doi: 10.1371/journal.pone.0124653. eCollection 2015.
10
Systematic review with meta-analysis: post-infectious irritable bowel syndrome after travellers' diarrhoea.系统评价与荟萃分析:旅行者腹泻后的感染后肠易激综合征。
Aliment Pharmacol Ther. 2015 Jun;41(11):1029-37. doi: 10.1111/apt.13199. Epub 2015 Apr 13.