在开始肝毒药物治疗后严重急性肝损伤在现实世界的数据中
Jessie Torgersen1,2, Alyssa K Mezochow1, Craig W Newcomb2
1Division of Infectious Diseases, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.
JAMA internal medicine
|June 24, 2024
概括
现实数据显示,药物诱导的急性肝损伤 (ALI) 发病率与病例报告的分类有很大的不同. 这项研究确定了高风险药物,改善了药物安全性评估.
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.
- 现实世界的证据研究研究.
背景情况:
- 目前的药物肝毒性分类依赖于病例报告,忽视了人群规模和暴露时间.
- 有限的现实数据存在于药物开始后严重急性肝损伤 (ALI) 发病率.
研究的目的:
- 用现实世界严重ALI的发病率来识别潜在的肝毒药物.
- 为了将这些现实世界比率与基于案例报告的现有分类进行比较.
主要方法:
- 一项队列研究分析了2000-2021年美国退伍军人事务部的数据.
- 包括7,899,888名患者开始服用194种疑似肝毒药物.
- 严重的ALI是由特定的肝酶和胆红素水平或INR定义的,并计算出发病率.
主要成果:
- 严重ALI的发病率差异很大,从0到86.4事件每10,000人年 (stavudine).
- 七种药物显示发生率≥10.0事件/10,000人/年;十种药物显示发生率在5.0-9.9.9之间.
- 在17种药物中,有11种具有最高ALI率的药物不在基于病例报告的顶级类别中.
结论:
- 严重ALI的现实发病率有效地识别潜在的肝毒药物.
- 这种方法是调查药物安全信号的宝贵工具.
- 病例报告的数量并不准确地反映了药物开始后观察到的严重ALI率.
相关概念视频
Pharmacovigilance
821
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...
821
Prevention of Further Absorption of Poison
816
In cases of acute poisoning, the primary objective is to prevent further absorption of the toxic substance into the body. Immediate interventions using various decontamination techniques targeting the gastrointestinal (GI) tract can achieve this. Decontamination is crucial to prevent poison from entering the systemic circulation, which involves washing affected areas with water and mild soap and removing contaminated clothing. Once external decontamination is done, attention must be turned to...
816
Hepatic Drug Excretion: Enterohepatic Cycling
1.5K
Enterohepatic cycling involves the active secretion of drugs and their metabolites into the bile via transporters in the canalicular membrane of hepatocytes. This secretion is an integral part of the digestive process, releasing these substances into the gastrointestinal (GI) tract.
Post-release drugs and metabolites can be reabsorbed into the body from the intestine. For conjugated metabolites like glucuronides, reabsorption requires enzymatic hydrolysis by intestinal microflora. This...
Post-release drugs and metabolites can be reabsorbed into the body from the intestine. For conjugated metabolites like glucuronides, reabsorption requires enzymatic hydrolysis by intestinal microflora. This...
1.5K
Factors Affecting Drug Response: Overview
2.0K
When it comes to infants and young children, they are typically administered smaller doses of medication in comparison to adults. This is primarily because their organ functions still need to fully develop, meaning their bodies are not as efficient at metabolizing or eliminating drugs. Additionally, their blood-brain barrier is more permeable than in adults. As a result, high concentrations of drugs can easily penetrate the central nervous system (CNS), potentially leading to neurological...
2.0K
Esophageal Varices-II: Clinical Features and Management
57
Esophageal varices often manifest as gastrointestinal bleeding episodes, presenting symptoms like hematemesis (vomiting of blood), hematochezia (passing fresh blood via the rectum), and melena (black, tarry stools). Other signs can include weight loss, anorexia, abdominal discomfort, jaundice, pruritus, altered mental status, and muscle cramps.
In the initial assessment, a thorough review of the patient's medical history is vital to identify risk factors such as liver disease, alcohol...
In the initial assessment, a thorough review of the patient's medical history is vital to identify risk factors such as liver disease, alcohol...
57
Toxic Reactions: Overview
966
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,...
966


