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沙特阿拉伯药物不良事件的规模与特征:一项系统综述

Magnitude and Characteristics of Adverse Drug Events in Saudi Arabia: A Systematic Review.

作者信息

Alharbi Lina, Almuraee Duaa, AteeqAllah Lama, Belal Wareef, Ali Sheraz

机构信息

Department of Pharmaceutical Care, Prince Mohammad Bin Abdulaziz Hospital, Ministry of National Guard, Madinah, Saudi Arabia.

Department of Pharmaceutical Care, King Faisal Specialist Hospital and Research Center, Madinah, Saudi Arabia.

出版信息

Saudi J Med Med Sci. 2025 Apr-Jun;13(2):79-89. doi: 10.4103/sjmms.sjmms_582_24. Epub 2025 Apr 21.

DOI:10.4103/sjmms.sjmms_582_24
PMID:40352340
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12063962/
Abstract

AIMS

We aimed to determine the prevalence, nature, and identification methods of the adverse drug events (ADEs) as well as explore if standard definitions were utilized while assessing ADEs in Saudi Arabia.

METHODS

We systematically searched MEDLINE via PubMed and Embase from their inceptions to April 2022. We investigated experimental and observational studies conducted in Saudi Arabia.

RESULTS

We screened 14,398 records and included 12 studies. This review indicated that the incidence of ADEs ranged from 0.58% to 74.2%, while three cross-sectional study reports highlighted that the proportion of subjects experiencing ADEs ranged from 28% to 98.5%. This wide variation can be attributed to factors such as diverse study designs, measurement variability, and heterogeneous populations. ADR was the most frequently reported type of ADE in all studies. Chart review (58%) was the commonly utilized ADE detection method, followed by patient interviews (25%), and trigger tools (17%). Five studies (42%) used their own ADE definition, and only one study (8%) reported the standard ADE definition; however, half of the studies ( = 6) did not report any ADE definition.

CONCLUSIONS

This systematic review suggests that ADE prevalence varied between studies, with chart review being the most used approach for ADE identification in Saudi Arabia, followed by patient interviews. ADR was the most common type of ADE among all studies. Further, most studies did not use the standard ADE definitions. To improve medication safety and patient care outcomes, our review highlights the crucial need for standardized ADE detection and reporting practices in Saudi Arabia. Future research should prioritize prospective studies with standardized methodologies to accurately assess ADE prevalence rates and evaluate the impact of interventions on reducing ADEs in Saudi Arabia.

摘要

目的

我们旨在确定药物不良事件(ADEs)的发生率、性质和识别方法,并探讨在沙特阿拉伯评估ADEs时是否使用了标准定义。

方法

我们通过PubMed和Embase系统检索MEDLINE,检索时间从其创刊至2022年4月。我们调查了在沙特阿拉伯进行的实验性和观察性研究。

结果

我们筛选了14398条记录,纳入了12项研究。该综述表明,ADEs的发生率在0.58%至74.2%之间,而三项横断面研究报告强调,经历ADEs的受试者比例在28%至98.5%之间。这种广泛的差异可归因于多种因素,如不同的研究设计、测量变异性和异质性人群。在所有研究中,药物不良反应(ADR)是最常报告的ADE类型。病历审查(58%)是常用的ADE检测方法,其次是患者访谈(25%)和触发工具(17%)。五项研究(42%)使用了自己的ADE定义,只有一项研究(8%)报告了标准的ADE定义;然而,一半的研究(n = 6)没有报告任何ADE定义。

结论

该系统综述表明,不同研究之间ADEs的发生率有所不同,病历审查是沙特阿拉伯最常用的ADE识别方法,其次是患者访谈。ADR是所有研究中最常见的ADE类型。此外,大多数研究未使用标准的ADE定义。为了提高用药安全性和患者护理结果,我们的综述强调了沙特阿拉伯标准化ADE检测和报告实践的迫切需求。未来的研究应优先采用标准化方法进行前瞻性研究,以准确评估ADEs的发生率,并评估干预措施对减少沙特阿拉伯ADEs的影响。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/38ee/12063962/6a9bb19796b1/SJMMS-13-79-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/38ee/12063962/6a9bb19796b1/SJMMS-13-79-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/38ee/12063962/6a9bb19796b1/SJMMS-13-79-g001.jpg

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本文引用的文献

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Medication Errors in Saudi Arabian Hospital Settings: A Systematic Review.沙特阿拉伯医院环境中的用药错误:系统评价。
Medicina (Kaunas). 2024 Aug 29;60(9):1411. doi: 10.3390/medicina60091411.
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The evaluation of adverse drug reactions in Saudi Arabia: A retrospective observational study.沙特阿拉伯药物不良反应的评估:一项回顾性观察研究。
Saudi Pharm J. 2022 Jun;30(6):735-741. doi: 10.1016/j.jsps.2022.03.018. Epub 2022 Mar 31.
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Actual drug-related harms in residential aged care facilities: a narrative review.养老机构中与药物相关的实际危害:叙事性综述。
Expert Opin Drug Saf. 2022 Aug;21(8):1047-1060. doi: 10.1080/14740338.2022.2084071. Epub 2022 Jun 2.
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Patterns of adverse drug reactions (ADRs) in Saudi Arabia.沙特阿拉伯的药物不良反应模式。
Saudi Pharm J. 2022 Jan;30(1):8-13. doi: 10.1016/j.jsps.2021.08.014. Epub 2021 Aug 4.
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Incidence and risk factors of adverse drug reactions in patients with coronavirus disease 2019: A pharmacovigilance experience utilizing an ADR trigger tool.2019冠状病毒病患者药物不良反应的发生率及危险因素:利用药物不良反应触发工具的药物警戒经验
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Development and Implementation of an e-Trigger Tool for Adverse Drug Events in a Swiss University Hospital.瑞士大学医院药物不良事件电子触发工具的开发与实施
Drug Healthc Patient Saf. 2021 Dec 24;13:251-263. doi: 10.2147/DHPS.S334987. eCollection 2021.
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Detection of adverse drug events in e-prescribing and administrative health data: a validation study.电子处方和行政健康数据中不良药物事件的检测:一项验证研究。
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Real-world safety experience with immune checkpoint inhibitors in Saudi Arabia.沙特阿拉伯免疫检查点抑制剂的真实世界安全性经验。
Sci Prog. 2021 Jan-Mar;104(1):36850421997302. doi: 10.1177/0036850421997302.
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Evaluation of medication error rates in Saudi Arabia: A protocol for systematic review and meta-analysis.评估沙特阿拉伯的用药错误率:系统评价和荟萃分析方案。
Medicine (Baltimore). 2021 Mar 5;100(9):e24956. doi: 10.1097/MD.0000000000024956.
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