使用日本自发报告系统对尼沃卢马布肺部不良事件的评估
Yuko Kanbayashi1, Tadashi Shimizu2, Asuka Kojima3
1Department of Education and Research Center for Clinical Pharmacy, Faculty of Pharmacy, Osaka Medical and Pharmaceutical University, 4-20-1 Nasahara, Takatsuki, Osaka, 569-1094, Japan. yuko.kambayashi@ompu.ac.jp.
Scientific reports
|May 31, 2023
概括
尼沃卢马布可以引起严重的肺部不良事件 (AE),包括间歇性肺部疾病,这可能是致命的. 患者需要在整个治疗期间和之后对这些副作用进行监测.
科学领域:
- 药物监督 药物监督 药物监督
- 肺部病理学 肺部病理学
- 在瘤学瘤学.
背景情况:
- 尼沃卢马布是一种免疫检查点抑制剂,用于癌症治疗.
- 肺部不良事件 (AE) 是已知的尼沃卢马布治疗并发症.
- 了解这些副作用的发生率,时间和结果对于患者安全至关重要.
研究的目的:
- 调查与nivolumab相关的肺部副作用的发生率,发病时间和结果.
- 从大型不良事件数据库中识别特定的肺部副作用及其风险信号.
- 为了为尼沃卢马布诱导的肺毒性提供临床监测策略的信息.
主要方法:
- 2004年4月至2021年3月,对日本药物不良事件报告数据库的分析.
- 提取和分析关于尼沃卢马布相关肺部副作用的数据.
- 使用报告几率比率估计相对风险.
主要成果:
- 分析了超过520万份报告,确定了3084个与尼沃卢马布相关的肺部副作用.
- 九个肺部副作用显示出显著的信号,包括间歇性肺病 (最常见,68.7%),肺炎和肺炎.
- 发病时间从34天到79天不等,一些病例发生在nivolumab启动后的一年多;报告有致命病例,特别是间歇性肺病.
结论:
- 尼沃卢马布与各种营销后肺部副作用有关,间歇性肺部疾病是一个重大问题.
- 早期和持续的患者监测是必不可少的,因为这些AE可能导致严重的后果和延迟发病.
- 在整个治疗过程和治疗后的随访过程中,需要保持临床警.
更多相关视频
相关概念视频
Pharmacovigilance
916
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...
916
Clinical Trials: Overview
3.1K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
3.1K
Clinical Trials
6.9K
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
There are four phases in a clinical trial. A phase one...
6.9K
Asthma-IV: Diagnostic and Management
2.6K
The diagnosis and management of asthma are comprehensive, encompassing clinical assessments, lung function tests, and pharmacological interventions. Here's an overview:
Clinical Assessment for Asthma:
This is the first step in diagnosing and managing asthma. It includes:
Clinical Assessment for Asthma:
This is the first step in diagnosing and managing asthma. It includes:
2.6K
Chronic Obstructive Pulmonary Disease-IV: Assessement and Diagnostic Studies
2.5K
Assessing and diagnosing Chronic Obstructive Pulmonary Disease (COPD) involves a detailed approach that includes a comprehensive review of medical history, physical examination, and a variety of diagnostic tests. This thorough evaluation is essential to ensure an accurate diagnosis and guide effective management strategies.
Medical History
Medical History
2.5K
Asthma-III: Symptoms and Complications
2.5K
Asthma, a common chronic respiratory condition, is classified considering the frequency and severity of symptoms alongside lung function impairment. Understanding this classification is essential for appropriate treatment and management. Here's a detailed look at the classification of asthma and its clinical features and complications:
Classification of Asthma
Classification of Asthma
2.5K


