相关实验视频

Updated: Jan 7, 2026

The Use of Gas Chromatography to Analyze Compositional Changes of Fatty Acids in Rat Liver Tissue during Pregnancy

The Use of Gas Chromatography to Analyze Compositional Changes of Fatty Acids in Rat Liver Tissue during Pregnancy

Published on: March 13, 2014

与阿扎西奥普林相关的妊娠的肝脏内胆固醇症:使用FDA不良事件报告系统的第一个定量不成比例分析

Yonghoon Kwon¹, Nai Lee¹, Yun Kim¹

¹College of Pharmacy, Daegu Catholic University, Gyeongsan, Republic of Korea.

Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques

|January 1, 2026

概括

怀孕期间使用阿扎西奥普林 (AZA) 可能与怀孕的肝脏内胆固醇症 (ICP) 有关,这是一个严重的疾病. 这项研究发现了AZA相关的ICP的显著报告信号,特别是在患有克罗恩病或性结肠炎的女性中.

科学领域:

药物监督药物监督药物监督
免疫抑制剂药物的安全性
怀孕并发症怀孕并发症

背景情况:

阿扎西奥普林 (AZA) 是一种免疫抑制剂,用于治疗类风湿性关节炎和预防移植排斥等疾病.
最近的FDA警告强调了AZA的潜在风险,包括妊娠肝脏内胆固醇症 (ICP),这是一种对母亲和胎儿构成风险的肝脏疾病.

研究的目的:

通过使用药监数据,调查阿扎西奥普林 (AZA) 和怀孕 (ICP) 的肝脏内胆固醇形成之间的潜在关联.
将AZA诱导的ICP报告频率与已知引起ICP的其他药物进行比较.

主要方法:

一项回顾性药物监测研究分析了1968年至2024年第二季度的FDA不良事件报告系统 (FAERS) 数据.
使用报告几率比率 (RORs) 的不成比例分析被用来评估AZA和ICP之间的关联.
亚组分析检查了怀孕状态和自身免疫指示,以及与其他ICP诱导药物的比较分析.

主要成果:

在与阿扎西奥普林 (AZA) 相关的不良事件报告中检测到ICP的强烈不成比例信号 (ROR025 = 153.0).
在孕妇 (ROR025 = 5.46) 和特别是那些患有克罗恩病 (ROR025 = 66.99) 和性结肠炎 (ROR025 = 9.01) 的孕妇中观察到与AZA相关的ICP显著信号.
对比分析表明,与AZA相关的ICP病例比例较高,与以前与ICP相关的其他药物相比.

结论:

这项药监测研究发现了一个显著的信号,表明阿扎西奥普林 (AZA) 与怀孕 (ICP) 的肝脏内胆固醇形成之间存在潜在的关联.
这些发现强调了在给生育年龄的妇女开药时需要仔细考虑和临床监测,因为ICP的潜在风险.

关键词:

亚扎西奥普林是一种阿扎西奥普林.怀孕期间的肝脏内胆固醇形成.药物监督和药物监督怀孕安全怀孕安全报告不成比例的信号

更多相关视频

An Intestine/Liver Microphysiological System for Drug Pharmacokinetic and Toxicological Assessment

An Intestine/Liver Microphysiological System for Drug Pharmacokinetic and Toxicological Assessment

Published on: December 3, 2020

相关概念视频

Effect of Hepatic Disease on Pharmacokinetics: Pathophysiologic Assessment and Liver Function Test

Effect of Hepatic Disease on Pharmacokinetics: Pathophysiologic Assessment and Liver Function Test

In clinical practice, the direct measurement of hepatic blood flow to evaluate liver function presents significant challenges due to the intricate and specialized nature of the necessary techniques. Consequently, healthcare professionals often rely on empirical estimates derived from thorough patient examinations and liver function tests to gauge liver health. Among the tools at their disposal, the Child–Pugh and MELD scoring systems stand out for their ability to categorize and assess...

Pharmacovigilance

Pharmacovigilance

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...

Effect of Hepatic Disease on Pharmacokinetics: Dose Adjustments Due to Hepatic Impairment

Effect of Hepatic Disease on Pharmacokinetics: Dose Adjustments Due to Hepatic Impairment

Hepatic impairment, characterized by decreased liver function, does not uniformly mandate adjustments in drug dosage. Whether dosage modifications are necessary depends on various factors related to the drug's metabolism and elimination pathways. If a drug is primarily excreted via the kidneys and bypasses significant hepatic processing, if it undergoes minimal metabolic transformation in the liver, or if it is volatile and primarily expelled through the lungs, dose adjustments may not be...