相关实验视频
Updated: Feb 13, 2026

13:19
Deep Neural Networks for Image-Based Dietary Assessment
Published on: March 13, 2021
10.0K
深入探讨与索托拉西布相关的肝胆副反应:基于FDA不良事件报告系统
Xinmei Pan1, Lin Zhang1, Linli Xie1
1Department of Pharmacy, the First Affiliated Hospital of Army Medical University (Third Military Medical University), Chongqing 400038, China.
Lung cancer (Amsterdam, Netherlands)
|February 11, 2026
概括
这项研究使用FAERS数据分析了与sotorasib相关的肝胆不良事件 (AE). 它确定了药物说明书中未列出的关键副作用,如肝功能异常,有助于安全的临床使用.
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:
- 索托拉西布是一种针对某些癌症的向治疗.
- 肝胆不良事件 (AEs) 是对索托拉西布治疗的一个担忧.
- 了解这些AE对于安全的临床应用至关重要.
研究的目的:
- 使用FAERS数据库探索与索托拉西布相关的肝胆性副作用.
- 识别和描述潜在的安全信号.
- 为安全临床使用索托拉西布提供参考.
主要方法:
- 从美国食品和药物管理局不良事件报告系统 (FAERS) 数据库提取数据 (2021年5月至2024年9月).
- 使用四种算法进行不成比例分析:ROR,PRR,BCPNN和MGPS.
- 专注于肝胆性副作用的分析,包括信号评估,特征描述和风险因素分析.
主要成果:
- 对索托拉西布报告了2383例副作用;291例在36个PTs中与肝胆副作用相关.
- 15个PT显示出积极的安全信号,其中11个药物说明中没有列出 (例如,肝功能异常,胆固醇,胆固醇性肝损伤).
- 索托拉西布和肝胆性副作用之间的相关性在不同的人口统计和报告类型中持续存在,并具有不同的模式.
结论:
- FAERS数据挖掘揭示了索托拉西布真正的肝胆毒性谱.
- 确定了影响因素和关键的副作用,包括那些不在药物标签上.
- 在临床实践中为管理与索托拉西布相关的肝胆不良反应提供了宝贵的见解.
相关概念视频
FDA Approved Drugs: Changes to Approved Drugs
275
Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
275
Local Anesthetics: Adverse Effects
815
While local anesthetics are generally safe and well-tolerated, they can occasionally cause adverse effects that vary in severity. Local anesthetics can induce toxicity at two distinct levels. They can either produce local effects through direct contact with the neural elements or be absorbed into the bloodstream from the injection site, leading to systemic effects.
Once absorbed into the systemic circulation, local anesthetics can affect the organs that depend on the functioning of sodium...
Once absorbed into the systemic circulation, local anesthetics can affect the organs that depend on the functioning of sodium...
815
Data Reporting and Recording
5.5K
Reporting and recording are crucial in data documentation. The timely, thorough, and accurate documentation of facts is essential when recording patient data. Failure to record findings during an assessment or interpretation of a problem will result in loss of information and make the patient document unreliable. The reader is left with general impressions if the information is not specific. A recording is documenting data of the individual's health information in a traceable, secure, and...
5.5K
Integration of Synaptic Events
4.2K
Synaptic integration mainly includes the summation of graded potentials. Graded potentials, regardless of their type, cause subtle alterations in membrane voltage, resulting in either depolarization or hyperpolarization. These incremental changes, when combined or summed, can propel the neuron toward its threshold. Consider, for example, a membrane experiencing a +15 mV shift, causing it to depolarize from -70 mV to -55 mV. In this scenario, graded potentials govern the membrane's ability to...
4.2K
Insulin: Dosing Regimen and Adverse Effects
835
Insulin-replacement therapy usually includes both long-acting insulin (basal) and short-acting insulin (to cater to postprandial needs). In a diverse group of type 1 diabetes patients, the average daily insulin dose is typically 0.5-0.7 units/kg body weight. However, obese patients and pubertal adolescents may need more due to insulin resistance.
The basal dose constitutes about 40%-50% of the total daily dose, with the rest as premeal insulin. The mealtime insulin dose should mirror...
The basal dose constitutes about 40%-50% of the total daily dose, with the rest as premeal insulin. The mealtime insulin dose should mirror...
835
Skeletal Muscle Relaxants: Adverse Effects
864
Skeletal muscle relaxants are widely used for muscle paralysis and relieving pain following any muscle injury or stiffness. However, depending on the drug type, they can have adverse effects that range from mild to severe. Usually, nondepolarizing neuromuscular blockers have minimal side effects. For example, drugs like d-tubocurarine, cisatracurium, and rocuronium cause hypotension, whereas drugs like baclofen, when stopped abruptly, can lead to the recurrence of spastic conditions.
Unlike...
Unlike...
864

