用自发不良药反应报告数据库评估由生物代理引起的间歇性肺病并发症
Ayu Minagi1, Hideki Nawa1,2,3, Mitsuhiro Goda4
1Department of Pharmacy, Faculty of Pharmacy, Shujitsu University, Okayama, Japan.
Pharmacology research & perspectives
|February 21, 2025
概括
间歇性肺病 (ILD) 是生物药物,特别是TNF-α抑制剂的严重风险. 这项研究在大型不良事件数据库中确定了ILD信号,强调了在生物治疗期间需要保持警.
科学领域:
- 药物监督 药物监督 药物监督
- 肺部病理学 肺部病理学
- 类风湿病学 类风湿病学
背景情况:
- 间歇性肺病 (ILD) 是已知的生物制剂不良事件,但其发病率缺乏大规模的风险评估.
- 生物疗法被广泛用于诸如牛皮,类风湿性关节炎和克罗恩病等自身免疫性疾病.
研究的目的:
- 通过使用全球药物不良反应数据库,评估生物制剂使用与ILD发展之间的关联.
- 检测与特定生物制剂相关的ILD安全信号.
主要方法:
- 利用了VigiBase自发不良事件报告数据库,包含超过3200万份报告.
- 分析了用于治疗牛皮,类风湿性关节炎和克罗恩病的9种生物药物的数据.
- 采用信息组件方法进行信号检测,并进行并发症和时间到事件分析.
主要成果:
- 在32.520.983份报告中,68.489份 (0.21%) 是针对ILD.
- 主要检测到重要的ILD信号主要是针对瘤亡因子-α (TNF-α) 抑制剂.
- 在不同生物药物中观察到并发症概况和ILD发病时间的变化.
结论:
- ILD是一种与生物药物,特别是TNF-α抑制剂相关的严重不良影响.
- 不能排除某些生物药物和ILD之间的因果关系.
- 临床医生应在生物治疗期间监测间歇性ILD,特别是使用TNF-α抑制剂.
更多相关视频
15:04Potentiation of Anticancer Antibody Efficacy by Antineoplastic Drugs: Detection of Antibody-drug Synergism Using the Combination Index Equation
Published on: January 19, 2019
12.1K
07:40A Data Integration Workflow to Identify Drug Combinations Targeting Synthetic Lethal Interactions
Published on: May 27, 2021
4.1K
相关概念视频
Pharmacovigilance
764
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
764
Allergic Drug Reactions
805
Allergic reactions related to drugs are hypersensitivity responses driven by the immune system and bear no connection to the drug's therapeutic action. While drugs in isolation do not trigger an immune response, they can interact with endogenous proteins to form antigens. These antigens stimulate lymphocytes to produce antibodies. IgE-type antibodies attach themselves to mast cells. Upon subsequent exposure to the same stimulus, the antigen-antibody interaction is initiated, unleashing...
805
Drugs for Treatment of Crohn's Disease in IBD Using Biologic Agents: Anti-TNF
107
Tumor Necrosis Factor (TNF), a proinflammatory cytokine, contributes significantly to the inflammation seen in Crohn's disease. It exists as soluble TNF and membrane-bound TNF, with actions mediated through TNF receptors (TNFR). TNFR activation leads to the release of proinflammatory cytokines, T-cell activation, collagen production, and leukocyte migration, all contributing to inflammation in Crohn's disease. Anti-TNF monoclonal antibodies, namely infliximab (Remicade), adalimumab...
107
Structure-Activity Relationships and Drug Design
484
Drug design is a dynamic field that involves discovering and developing new medications based on specific biological targets. This process heavily relies on structure-activity relationships (SAR) and quantitative structure-activity relationships (QSAR) to guide the design and optimization of efficient drugs.
SAR studies the intricate relationship between a drug's chemical structure and biological activity. It focuses on understanding how modifications to a drug's structure can influence...
SAR studies the intricate relationship between a drug's chemical structure and biological activity. It focuses on understanding how modifications to a drug's structure can influence...
484
Drugs Used in Lower Respiratory Disorders: Overview
341
Lower respiratory tract disorders present challenges that often require skilled and nuanced approaches for effective management. Common ailments, such as asthma and chronic obstructive pulmonary disease (COPD), have prompted the development of intricate treatment strategies involving bronchodilators and anti-inflammatory drugs, each tailored to ease breathing and revitalize the lungs.
Bronchodilators, the first step of respiration enhancement, come in various forms, each with its own mechanism...
Bronchodilators, the first step of respiration enhancement, come in various forms, each with its own mechanism...
341
