来自FAERS数据库的药物诱导的自身免疫性肝炎的现实世界药监测研究
Bu-Kun Zhu1, Si-Ying Chen2, Xiang Li3
1Department of Infection, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China.
Scientific reports
|February 8, 2025
概括
这项研究使用FDA数据确定了22种与药物诱导的自身免疫性肝炎 (DI-AIH) 相关的药物. 米诺环素,尼托福兰和多克西环素显示出最高的风险,强调需要仔细监测药物.
科学领域:
- 药物监督 药物监督 药物监督
- 肝病学 肝病学是一种肝病学.
- 药品安全 药品安全
背景情况:
- 自免疫性肝炎 (AIH) 可以由药物引起,称为药物诱导的AIH (DI-AIH).
- 确定与DI-AIH相关的特定药物对于患者安全和临床管理至关重要.
- 美国食品和药物管理局的不良事件报告系统 (FAERS) 数据库是药监研究的宝贵资源.
研究的目的:
- 识别和评估通常与患自身免疫性肝炎的风险相关的药物.
- 分析与药物诱导的AIH相关的不良药物事件的发病时间.
主要方法:
- 利用FAERS数据库 (2004年1月至2024年6月) 来检索与AIH相关的不良药物事件.
- 采用不成比例分析来识别与DI-AIH有显著关联的药物.
- 进行了时间到发病 (TTO) 分析,以评估DI-AIH不良反应的时间和风险概况.
主要成果:
- 确定了2511个与AIH相关的ADEs.
- 不成比例分析显示,22种药物与AIH风险有显著的关联,包括抗生素,抗病毒药物,心血管药物和抗瘤药物.
- 米诺环素 (ROR=53.97),尼托福兰 (ROR=57.02) 和多克西环素 (ROR=16.12) 显示了最高的DI-AIH风险. 抗瘤药物TTO中位数最短 (77天),而心血管药物TTO中位数最长 (668.3天).
结论:
- 这项对FAERS数据库的全面分析确定了与AIH强烈相关的特定药物.
- 防止DI-AIH需要明智的药物选择和警的患者监测.
- 这些发现提供了基于证据的见解,以优化临床管理和减轻与DI-AIH相关的风险.
相关概念视频
Pharmacovigilance
769
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...
769
Allergic Drug Reactions
806
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...
806
Drug Regulation
1.3K
Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
1.3K
Autoimmune Disorders
379
Autoimmune diseases are a group of disorders in which the body's immune system mistakenly attacks its own cells, tissues, and organs. This results from an overactive immune response against substances and tissues normally present in the body. Let's delve into the concept and mechanism of autoimmune diseases from an immune system point of view, explore different causes and examples of such diseases, and discuss potential solutions.
Concept and Mechanism of Autoimmune Diseases
The immune...
Concept and Mechanism of Autoimmune Diseases
The immune...
379


