达丁类药物的肝毒性:基于美国食品和药物管理局不良事件报告系统数据库的现实研究
Bojing Wang1, Shu Huang2,3, Shiqi Li1
1Department of Gastroenterology, The Affiliated Hospital of Southwest Medical University, Luzhou, China.
Frontiers in pharmacology
|January 22, 2025
概括
药物可以导致肝损伤,阿托瓦斯塔丁,西姆瓦斯塔丁和罗斯瓦斯塔丁的肝病发病率较高. 这项分析强调了特定的肝毒性风险,以确保更安全的临床决策.
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:
- 类药物是预防心血管疾病的关键降脂药物.
- 广泛使用他类药物引起了人们对不良事件的担忧,特别是肝毒性.
- 与他类药物相关的肝毒性需要显著的临床关注.
研究的目的:
- 进行对他类药物诱导的肝毒性进行全面分析.
- 为了识别与他类药物使用相关的特定不良事件信号.
- 提供关于他类药物治疗的安全临床决策的科学基础.
主要方法:
- 使用美国食品和药物管理局不良事件报告系统数据库 (2004-2024年).
- 雇员报告几率比率和经验贝叶斯几何平均值用于不利事件信号挖掘.
- 分析了关于肝脏疾病的七种他类药物的数据.
主要成果:
- 所有七种他类药物都显示出肝脏疾病的积极信号,有14511例报告的病例.
- 阿托瓦斯塔丁,西姆瓦斯塔丁和罗斯瓦斯塔丁的肝脏不良事件发生率更高.
- 在多种他类药物中发现了自身免疫性肝炎和药物诱导的肝损伤的积极信号;阿托瓦斯塔丁显示了胆固醇和异常胆红素结合的显著信号.
结论:
- 确定了特定的不良事件信号,表明他类药物的潜在肝毒性风险.
- 结果为他类药物的安全临床应用提供了宝贵的见解.
- 结果支持临床医生做出明智和更安全的治疗决策.
相关概念视频
Lipid-Lowering Drugs: Statins and Miscellaneous Agents
526
Hyperlipidemia, a medical condition often referred to as high cholesterol, is characterized by abnormally elevated levels of lipids in the bloodstream. When present in excess, these lipids, specifically cholesterol and triglycerides, can lead to serious health complications, often involving cardiovascular diseases. Illnesses like atherosclerosis, heart attacks, and pancreatitis have all been linked to untreated hyperlipidemia. This means controlling and regulating cholesterol and triglyceride...
526
Pharmacovigilance
770
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...
770
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
Drug Distribution: Tissue Binding
2.5K
Upon entering the systemic circulation, drugs can distribute into the interstitial and intracellular fluid of various tissue cells. This distribution is facilitated by the binding of drugs to different cellular components within tissues, which may lead to drug accumulation in specific areas. Drugs bound to tissue components serve as reservoirs that release free drugs back into the system, prolonging the drug's overall action. However, this accumulation can also result in local toxicity.
For...
For...
2.5K
Toxic Reactions: Overview
938
When toxic substances penetrate the human body, they disseminate to various tissues, undergoing metabolic changes. This process yields reactive metabolites that may covalently bind with specific target molecules, resulting in toxicity.
Toxicity falls into two primary categories: local and systemic.
Local toxicity appears at the exposure site, such as protein denaturation caused by caustic substances.
In contrast, systemic toxicity requires the toxic agent's absorption and distribution,...
Toxicity falls into two primary categories: local and systemic.
Local toxicity appears at the exposure site, such as protein denaturation caused by caustic substances.
In contrast, systemic toxicity requires the toxic agent's absorption and distribution,...
938
Hepatic Drug Excretion: Influencing Factors
79
The biliary system of the liver, crucial for bile secretion and drug excretion, comprises intrahepatic bile ducts that merge to form the common hepatic duct. This duct, carrying hepatic bile, combines with the cystic duct, draining the gallbladder and forming the common bile duct, which empties into the duodenum. Bile, produced by hepatic cells lining the bile canaliculi, is composed primarily of water, bile salts, pigments, electrolytes, and lesser amounts of cholesterol and fatty acids. Bile...
79


