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糖尿病患者经历的药物不良事件模式：一项初级保健中的日记研究。

Adverse drug event patterns experienced by patients with diabetes: A diary study in primary care.

作者信息

Denig Petra, van Puijenbroek Eugène P, Soliman Nashwa, Mol Peter G M, de Vries Sieta T

机构信息

Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.

Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands.

出版信息

Pharmacoepidemiol Drug Saf. 2019 Sep;28(9):1175-1179. doi: 10.1002/pds.4839. Epub 2019 Jun 17.

DOI:10.1002/pds.4839
PMID:31209934
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6771843/
Abstract

PURPOSE: Little is known about adverse drug events (ADEs) experienced over time during chronic drug use. The purpose of this study was to assess ADE patterns experienced by patients with diabetes. METHODS: Patients who received an oral glucose-lowering drug completed a daily diary for 13 weeks. The diary asked for experienced symptoms and whether patients related these symptoms to any drug they used. Summaries of Product Characteristics were used to check whether the ADEs were known adverse drug reactions (ADRs) of the drugs used. Patterns of weekly occurring ADEs were assessed with descriptive statistics. RESULTS: We included 78 patients. Almost half of them reported at least one ADE (N = 36; 46%). In total, 80 ADEs were reported. Of these ADEs, 71 (90%) were known ADRs. ADEs lasted less than 1 week in 27 cases (34%) and between 2 and 12 weeks in 15 cases (19%). The remaining ADEs fluctuated (16 cases; 20%) or persisted (22 cases; 28%) during the entire study period. CONCLUSIONS: ADEs experienced by patients with diabetes can fluctuate or persist over long periods of drug use.

摘要

目的：关于长期使用慢性药物期间发生的药物不良事件（ADEs），我们了解甚少。本研究的目的是评估糖尿病患者经历的ADEs模式。 方法：接受口服降糖药物治疗的患者完成了为期13周的每日日记。日记询问了所经历的症状以及患者是否将这些症状与他们使用的任何药物相关联。使用产品特性摘要来检查这些ADEs是否为所用药物已知的药物不良反应（ADRs）。采用描述性统计评估每周发生的ADEs模式。 结果：我们纳入了78名患者。其中近一半报告了至少一种ADE（N = 36；46%）。总共报告了80起ADEs。在这些ADEs中，71起（90%）是已知的ADRs。27例（34%）ADEs持续时间少于1周，15例（19%）持续2至12周。其余的ADEs在整个研究期间波动（16例；20%）或持续存在（22例；28%）。 结论：糖尿病患者经历的ADEs在长期用药期间可能波动或持续存在。

相似文献

[1]
Adverse drug event patterns experienced by patients with diabetes: A diary study in primary care.

Pharmacoepidemiol Drug Saf. 2019-9

[2]
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[4]
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[5]
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[6]
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[7]
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[9]
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引用本文的文献

[1]
Diabetes mellitus increases risk of adverse drug reactions and death in hospitalised older people: the SENATOR trial.

Eur Geriatr Med. 2024-2

[2]
Sex Differences in Adverse Drug Reactions of Metformin: A Longitudinal Survey Study.

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本文引用的文献

[1]
Time course, outcome and management of adverse drug reactions associated with metformin from patient's perspective: a prospective, observational cohort study in the Netherlands.

Eur J Clin Pharmacol. 2016-5

[2]
Parametric time-to-onset models were developed to improve causality assessment of adverse drug reactions from antidiabetic drugs.

J Clin Epidemiol. 2015-3-9

[3]
Construct and concurrent validity of a patient-reported adverse drug event questionnaire: a cross-sectional study.

Health Qual Life Outcomes. 2014-8-13

[4]
The validity of a patient-reported adverse drug event questionnaire using different recall periods.

Qual Life Res. 2014-11

[5]
Experiences with the use of varenicline in daily practice in the Netherlands: a prospective, observational cohort study.

Drug Saf. 2014-6

[6]
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Saudi Pharm J. 2013-2-24

[7]
A qualitative study to explore how patients identify and assess symptoms as adverse drug reactions.

Eur J Clin Pharmacol. 2014-5

[8]
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Drug Saf. 2013-9

[9]
Representativeness of diabetes patients participating in a web-based adverse drug reaction monitoring system.

Pharmacoepidemiol Drug Saf. 2012-8-30

[10]
Longitudinal monitoring of the safety of drugs by using a web-based system: the case of pregabalin.

Pharmacoepidemiol Drug Saf. 2011-6

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