与蛋白酶抑制剂和免疫调节药物相关的周围神经病变:使用VigiBase进行药物监测不成比例分析
Letícia Penna Braga1, Cristiane Aparecida Menezes de Pádua1, Iwyson Henrique F da Costa1,2
1Faculdade de Farmácia, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.
Pharmacology research & perspectives
|December 5, 2025
概括
用于多发性骨髓瘤的免疫调节药物 (IMID) 和蛋白酶体抑制剂 (PI) 会增加外围神经病变的风险. 这项研究发现了这些药物与感觉,运动和自主神经功能障碍之间的关联.
科学领域:
- 药物监督 药物监督 药物监督
- 神经学 神经学
- 在瘤学瘤学.
背景情况:
- 免疫调节药物 (IMID) 和蛋白酶体抑制剂 (PI) 是多发性骨髓瘤 (MM) 的关键治疗方法.
- 周围神经病变是与这些MM疗法相关的显著不良影响.
- 了解与IMID和PI相关的特定神经功能障碍类型对于患者管理至关重要.
研究的目的:
- 研究IMIDs和PI与多发性骨髓瘤患者的外周神经病变之间的关联.
- 根据神经功能障碍的类型来分层这些关联:感觉,运动或自主.
- 在这些类别中识别出具有较高神经病变风险的特定药物.
主要方法:
- 从VigiBase (世界卫生组织全球数据库) 分析个体病例安全报告 (ICSR).
- 包括2001年12月1日至2023年5月31日期间报告的ICSR.
- 使用MedDRA术语和标准化查询识别外围神经病变;使用ROR和IC进行不成比例分析.
主要成果:
- 所有分析的IMID和PI都显示出与外围神经病变的关联.
- 这两类药物都与外围感官神经病变有关.
- 具体的关联包括博尔特佐米布,伊克萨佐米布,卡菲尔佐米布和塔利多米德与自主神经病变;博尔特佐米布,塔利多米德,莱纳利多米德和波马利多米德与外围运动神经病变.
结论:
- IMIDs和PI与多发性骨髓瘤患者的各种类型的外围神经病变有显著的关联.
- 博尔特佐米布和沙利多米德与外围运动神经病变有很强的关联.
- 这些发现强调了需要对接受IMIDs和PI治疗多发性骨髓瘤的患者的神经不良事件的警监测.
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: Affecting Factors
182
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.
182
Therapeutic Drug Monitoring: Overview and Classification
275
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...
275
Bioequivalence studies: Biowaivers
210
Body:In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
210
Chemotherapy-Induced Nausea and Vomiting: Dopamine Receptor Antagonists
790
Dopamine receptor antagonists, also known as antipsychotic agents, are critical in managing chemotherapy-induced vomiting. These antiemetic agents block dopamine receptors in the chemoreceptor trigger zone (CTZ), inhibiting signal transmission to the vomiting center. Antipsychotic agents encompass phenothiazines (PTZ), butyrophenones, benzamides, and thienobenzodiazepines (Zyprexa), which are utilized for their antiemetic and sedative properties.
Phenothiazines, such as prochlorperazine...
Phenothiazines, such as prochlorperazine...
790
Therapeutic Drug Monitoring: Drug Analysis Methods
164
Therapeutic Drug Monitoring (TDM) is a clinical practice that measures specific drug levels in a patient's blood or body tissues to tailor drug therapy effectively. This monitoring is critical for managing drugs with narrow therapeutic indices like digoxin and phenytoin, ensuring they are both safe and effective. For instance, monitoring theophylline levels in asthma patients involves precision and sensitivity to adjust doses according to individual responses to therapy, ensuring efficacy and...
164


