关于实验性瘤学的多中心跨专业共识与药物相关的眼部不良事件报告
Neel D Pasricha1,2, Stella K Kim3, Asim V Farooq4
1Department of Ophthalmology, University of California, San Francisco.
JAMA ophthalmology
|December 4, 2025
概括
新的眼部分级尺度改善了接受实验性瘤药物治疗的患者不良事件 (AE) 的报告. 这些标准化尺度提高了患者的安全性,并指导了新型癌症治疗方法的开发.
科学领域:
- 眼科医生 眼科 眼科
- 在瘤学瘤学.
- 临床试验 临床试验
背景情况:
- 目前的眼科不良事件常用术语标准 (CTCAE) 缺乏标准化,混杂症状和迹象,并省略剂量修改指南.
- 对眼部不良事件 (AE) 进行强有力的报告对于患者安全和开发有效的瘤药物至关重要.
研究的目的:
- 开发改进的眼部AE分级尺度,用于评估正在接受实验性瘤药物治疗的患者的AE.
- 为眼部AE提供明确的药物剂量修改建议.
主要方法:
- 在2023年2月,一个由瘤学家和眼科医生组成的多中心合作工作组成立.
- 专家们就新的实验性瘤学药物相关的眼部AE分级表达达了共识,该表格于2023年6月发布.
主要成果:
- 为抗体药物联合临床试验开发了六种新的眼部AE分级尺度:视力敏度,眼睛症状,角膜,结膜/硬膜,前腔和视网膜/后段.
- 这些尺度包括标准化临床照片,如适用.
结论:
- 新的尺度比以前的CTCAE更简洁,包括明确的药物剂量修改建议.
- 这些分级尺度促进客观和一致的眼睛AE的测量,有助于新瘤药物的安全测试.
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
Clinical Trials: Overview
4.5K
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...
4.5K
Open Angle Glaucoma: Treatment
917
In open-angle glaucoma, the iridocorneal angle remains open, but the trabecular meshwork becomes stiff, slowing down the outflow of aqueous humor. This causes a buildup of aqueous humor in the anterior chamber, leading to a sudden increase in intraocular pressure. The treatment for open-angle glaucoma focuses on reducing the elevated intraocular pressure by either decreasing the secretion of aqueous humor or increasing its outflow.
Drugs such as carbonic anhydrase inhibitors, α2- and...
Drugs such as carbonic anhydrase inhibitors, α2- and...
917


