探索Nefecon的新型不良事件
Jingyu Wang1,2,3,4,5, Zhao Zhang1,2,3,4,5, Xingzi Liu1,2,3,4,5
1Renal Division, Peking University First Hospital, Beijing, China.
Kidney international reports
|September 18, 2024
概括
新的IgA脏病药物Nefecon在现实数据中显示出良好的安全性,没有发现高优先级的不良事件. 发现了新的副作用,有助于早期临床监测.
科学领域:
- 药物监督 药物监督 药物监督
- 腎臟病學 (nephrology) 是一種醫學專業.
- 药品安全 药品安全
背景情况:
- 尼菲康是第一个FDA和EMA批准的IgA脏病 (IgAN) 药物.
- 此前,对于Nefecon缺乏全面的真实世界不良事件 (AE) 数据.
- 营销后监测对于了解药物安全性概况至关重要.
研究的目的:
- 使用美国FDA FAERS数据对Nefecon的不良事件进行现实世界的评估.
- 为了确定潜在的安全信号,并描述Nefecon在IGAN患者中的AE概况.
- 评估新的不良事件,并评估临床优先级.
主要方法:
- 使用了美国FDA不良事件报告系统 (FAERS) 的营销后数据.
- 使用不成比例分析 (DPA) 来检测SOC和PT级别的安全信号.
- 排除了使用MedDRA的重复和先前报告的副作用;分析了发病时间,累计发病率和子组数据.
主要成果:
- 确定了5个积极的SOC信号和23个积极的PT信号.
- 发现了4种新的副作用:喘息,不适,产品剂量遗漏和焦虑.
- 没有高优先级的临床事件;中等优先级的事件包括,高血压,面部胀和体重增加.
结论:
- 在IgA脏病患者中,Nefecon表现出有利的现实安全概况.
- 该研究确定了新的副作用和子组特异性风险,提高了早期临床警.
- 调查结果为Nefecon持续的安全监测提供了有价值的数据.
相关概念视频
01:12Local Anesthetics: Adverse Effects
399
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...
399
01:28Chemotherapy-Induced Nausea and Vomiting: Neurokinin-1 Receptor Antagonists
153
Neurokinin 1 (NK1) receptors are distributed across the GI tract, vagal afferents, and key CNS regions including the central vomiting center and chemoreceptor trigger zone (CTZ) Chemotherapy agents stimulate enterochromaffin cells in the gastrointestinal (GI) tract to release large amounts of substance P (SP). SP is a neuropeptide released by specific sensory nerves in response to many different stressors, including those in the GI mucosa affected by chemotherapy. SP binds and activates...
153
01:19Pharmacovigilance
786
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...
786
01:28Esophageal Perforation-II: Clinical Manifestations and Management
45
Esophageal perforations manifest in various clinical forms, influenced by factors such as the perforation's cause and location (cervical, intrathoracic, or intra-abdominal), the extent of contamination, and potential injury to adjacent mediastinal structures. The timing between the perforation occurrence and treatment initiation also affects the clinical presentation.
Clinical Manifestations:
Clinical Manifestations:
45
01:29Chemotherapy-Induced Nausea and Vomiting: Dopamine Receptor Antagonists
236
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...
236
01:27Chemotherapy-Induced Nausea and Vomiting: 5-HT3 Receptor Antagonists
181
5-HT3 receptor antagonists, such as dolasetron, granisetron (Kytril), ondansetron (Zofran), and palonosetron (Axoli), are crucial in managing chemotherapy-induced nausea and vomiting (CINV) and postoperative nausea. These drugs selectively block 5-HT3 receptors in the visceral vagal and spinal afferent nerves, chemoreceptor trigger zone, and the vomiting center. They have a rapid onset of action and can be given as a single dose before chemotherapy. Ondansetron and granisetron, in particular,...
181