在多发性硬化症中使用克拉迪宾的营销后安全概况:基于FDA不良事件报告系统的不成比例分析
Yuwen Hu1, Jianghai He1, Zheng Tu1
1Department of Neurology, Postgraduate Training Base Alliance of Wenzhou Medical University, Wenzhou People's Hospital, Wenzhou, 325000, Zhejiang, China.
International journal of clinical pharmacy
|November 15, 2025
概括
这项研究使用现实世界的数据在多发性硬化症 (MS) 患者中确定了与克拉迪宾相关的已知和新的不良事件 (AE). 调查结果强调需要对克拉德里宾治疗早期急性毒性保持警.
科学领域:
- 药物监督 药物监督 药物监督
- 神经学 神经学
- 临床安全 临床安全
背景情况:
- 克拉迪宾是复发性复发性多发性硬化症 (MS) 的公认治疗方法.
- 在MS患者中使用克拉迪宾的真实安全数据仍然有限.
- 评估不良事件 (AEs) 对于了解克拉德里宾的安全概况至关重要.
研究的目的:
- 在多发性硬化症 (MS) 患者中评估与克拉迪宾相关的不良事件 (AEs).
- 使用现实数据识别潜在的新安全信号.
- 分析与克拉迪相关的副作用的发病时间模式.
主要方法:
- 从美国食品和药物管理局的不良事件报告系统 (FAERS) (Q1 2019Q3 2024) 提取了AE报告.
- 使用四种不成比例方法 (ROR,PRR,ANN,EBG) 来评估与克拉迪相关的副作用.
- 利用韦布尔分布进行时间到发病分析,并根据性别和年龄进行子组分析.
主要成果:
- 确定了113个与cladribine相关的首选术语 (PT),包括已知的AEs如肺炎和淋巴缺血症,以及诸如风湿性关节炎和心肌梗塞等意想不到的事件.
- 分层分析揭示了女性 (恶心,脱发),男性 (行走障碍,败血症) 和老年人 (白血病,尿道感染) 的特定风险.
- 平均AE发病时间为152天,在第一个月达到早期峰值,这表明迅速发病的毒性.
结论:
- 这项研究证实了克拉迪宾已知的安全风险,并揭示了新的潜在安全信号.
- 强调需要加强对克拉迪宾治疗多发性硬化症患者早期急性毒性的警.
- 现实世界的数据分析提供了超越临床试验的克拉迪宾安全概况的宝贵见解.
相关概念视频
Pharmacovigilance
1.6K
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...
1.6K
Therapeutic Drug Monitoring: Overview and Classification
282
Therapeutic Drug Monitoring (TDM) is a clinical practice that measures specific drug levels in a patient's blood at designated intervals to ensure the drug concentration stays within a therapeutic range. This monitoring is crucial for optimizing individual dosage regimens, enhancing therapeutic efficacy, and minimizing drug-related toxicity. TDM is vital for drugs with narrow therapeutic windows, significant variability in pharmacokinetics, and a clear correlation between plasma levels and...
282
Therapeutic Drug Monitoring: Affecting Factors
189
Therapeutic Drug Monitoring (TDM) is the clinical practice of measuring specific drug levels in a patient's blood or body tissues to manage and optimize therapy. TDM is crucial for drugs with narrow therapeutic windows, like warfarin and phenytoin, where incorrect doses can lead to treatment failure or severe side effects. This monitoring ensures the dosage administered is within a safe and effective range. The factors affecting therapeutic drug monitoring include:Patient-Specific Factors:a.
189
FDA Approved Drugs: Changes to Approved Drugs
236
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,...
236
Drug Administration and Therapy Phases: Overview
1.2K
Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
1.2K
Drug Accumulation During Multiple Dosing: Repetitive IV Injections
242
Calculating drug dosage and accumulation in multiple-dose regimens is crucial for achieving therapeutic efficacy while avoiding toxicity. This involves determining the plasma drug concentrations over time to optimize dosing schedules. The principle of superposition is fundamental in this process, allowing for the prediction of drug concentration in plasma following multiple doses based on single-dose data.The principle of superposition asserts that the plasma concentration-time curves from...
242


