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药物警戒——技术进步、最新进展与创新

Pharmacovigilance - Technological Advancements, Recent Developments and Innovations.

作者信息

Gomase Virendra S

机构信息

S.P. Mandali's Prin. L. N. Welingkar Institute of Management Development & Research, Mumbai, 400019, India.

出版信息

Curr Drug Saf. 2025;20(4):423-449. doi: 10.2174/0115748863356840250112181406.

DOI:10.2174/0115748863356840250112181406
PMID:39931995
Abstract

Pharmacovigilance is an important subject in medicine and healthcare, which aims to prevent side effects and other drug-related problems by identifying, evaluating, understanding, and avoiding them. Its main objectives are ensuring that a drug's benefits balance its hazards and improving patient safety. Within medicine and healthcare, pharmacovigilance is an essential subject that focuses on identifying, evaluating, comprehending, and preventing side effects or any other issues associated with drugs. Its main objective is to improve patient safety and ensure a drug's advantages exceed its drawbacks. Pharmacovigilance has evolved significantly as a result of technological advancements, enabling more efficient medication, safety monitoring, and management. The combination of machine learning (ML) with artificial intelligence (AI) for data analysis, adverse reaction prediction, and signal detection, electronic health records (EHRs), and mobile health (mHealth) applications have enhanced real-time data collecting and expedited the reporting of adverse drug reactions (ADRs). Pharmacovigilance plays an important role which focuses on detecting, assessing, comprehending, and averting adverse medication reactions. Making sure a drug's advantages outweigh its disadvantages is its main objective to improve patient safety. Pharmacovigilance, which balances patient safety, efficacy, and regulatory compliance in clinical trials, is necessary to promote the safe and effective use of drugs.

摘要

药物警戒是医学和医疗保健领域的一个重要课题,其目的是通过识别、评估、理解和避免副作用及其他与药物相关的问题。其主要目标是确保药物的益处大于风险,并提高患者安全性。在医学和医疗保健领域,药物警戒是一个重要课题,专注于识别、评估、理解和预防与药物相关的副作用或任何其他问题。其主要目标是提高患者安全性,并确保药物的优点超过缺点。由于技术进步,药物警戒有了显著发展,实现了更高效的药物治疗、安全监测和管理。将机器学习(ML)与人工智能(AI)相结合用于数据分析、不良反应预测和信号检测、电子健康记录(EHR)以及移动健康(mHealth)应用,增强了实时数据收集,并加快了药物不良反应(ADR)的报告。药物警戒发挥着重要作用,专注于检测、评估、理解和避免药物不良反应。确保药物的优点超过缺点是其提高患者安全性的主要目标。在临床试验中平衡患者安全性、疗效和法规遵从性的药物警戒,对于促进药物的安全有效使用是必要的。

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本文引用的文献

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Comprehensive evaluation of leuprorelin-associated adverse events: insights from FDA adverse event reporting system.亮丙瑞林相关不良事件的综合评估:来自美国食品药品监督管理局不良事件报告系统的见解
Expert Opin Drug Saf. 2025 Mar;24(3):355-364. doi: 10.1080/14740338.2024.2423680. Epub 2024 Oct 31.
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Psychiatric disorders associated with fluoroquinolones: a pharmacovigilance analysis of the FDA adverse event reporting system database.与氟喹诺酮类药物相关的精神障碍:对美国食品药品监督管理局不良事件报告系统数据库的药物警戒分析
Front Pharmacol. 2024 Oct 14;15:1435923. doi: 10.3389/fphar.2024.1435923. eCollection 2024.
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Pharmacovigilance monitoring and treatment adherence in patients on antihypertensive drugs at a tertiary care centre.
三级医疗中心接受抗高血压药物治疗患者的药物警戒监测与治疗依从性
Drugs Context. 2024 Oct 22;13. doi: 10.7573/dic.2024-5-2. eCollection 2024.
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A real-world pharmacovigilance study of FDA adverse event reporting system events for Lutetium-177-PSMA-617.镥[177Lu]-前列腺特异性膜抗原 617 药物不良反应真实世界监测研究
Sci Rep. 2024 Oct 28;14(1):25712. doi: 10.1038/s41598-024-77889-3.
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An Awareness of Pharmacovigilance Among Healthcare Professionals Due to an Underreporting of Adverse Drug Reactions Issue: A Systematic Review of the Current State, Obstacles, and Strategy.由于不良反应报告不足问题,提高医疗保健专业人员对药物警戒的认识:当前状况、障碍和策略的系统评价。
Curr Drug Saf. 2024;19(3):317-331. doi: 10.2174/0115748863276456231016062628.
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Pharmacovigilance in Vaccines: Importance, Main Aspects, Perspectives, and Challenges-A Narrative Review.疫苗的药物警戒:重要性、主要方面、前景与挑战——一篇叙述性综述
Pharmaceuticals (Basel). 2024 Jun 19;17(6):807. doi: 10.3390/ph17060807.
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Pharmacovigilance Strategies to Address Resistance to Antibiotics and Inappropriate Use-A Narrative Review.应对抗生素耐药性和不当使用的药物警戒策略——一篇叙述性综述
Antibiotics (Basel). 2024 May 16;13(5):457. doi: 10.3390/antibiotics13050457.
8
Adverse events associated with immune checkpoint inhibitors in non-small cell lung cancer: a safety analysis of clinical trials and FDA pharmacovigilance system.免疫检查点抑制剂在非小细胞肺癌中的不良反应:临床试验和 FDA 药物警戒系统的安全性分析。
Front Immunol. 2024 Apr 30;15:1396752. doi: 10.3389/fimmu.2024.1396752. eCollection 2024.
9
Global trends in pharmacovigilance-related events: a 30-year analysis from the 2019 global burden of disease study.全球药物警戒相关事件趋势:2019 年全球疾病负担研究三十年分析。
Int J Clin Pharm. 2024 Oct;46(5):1076-1090. doi: 10.1007/s11096-024-01738-6. Epub 2024 May 10.
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A Pilot, Predictive Surveillance Model in Pharmacovigilance Using Machine Learning Approaches.基于机器学习方法的药物警戒中的预测性监测模型:一个先导研究
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