临床实践中脂质乳液的安全性概况:使用FDA不良事件报告系统的药监测研究
Akira Okada1,2, Shoji Sera1,2, Koki Takeda1
1Laboratory of Regulatory Science, Faculty of Pharmacy, Musashino University, Nishi-Tokyo, Japan.
Annals of nutrition & metabolism
|July 22, 2024
概括
脂质乳液可以引起肝功能障碍和感染等不良事件,特别是在施用后的早期. 仔细监测肝功能和甘油三对于临床使用期间的患者安全至关重要.
科学领域:
- 临床药房 临床药房
- 药物监督 药物监督 药物监督
- 代谢过程中的代谢.
背景情况:
- 脂质乳液在临床上有用,但与不良事件有关.
- 现实世界的数据分析对于理解安全概况至关重要.
研究的目的:
- 在临床实践中分析脂质乳液的安全性.
- 为了识别和评估与脂质乳液使用相关的不良事件.
主要方法:
- 使用了美国食品和药物管理局不良事件报告系统数据库.
- 通过报告的几率比率和时间到发病分析评估不良事件风险.
主要成果:
- 确定了4430份与脂质乳液相关的不良事件报告.
- 肝功能障碍发生在早期,受甘油三含量的影响.
- 感染风险是早期的,但没有受到甘油三含量的显著影响.
结论:
- 脂质乳液不良事件需要全面的安全管理,特别是在治疗的早期.
- 靠肠道营养的患者需要监测肝功能和甘油三.
- 建议对输液速率进行重新评估,以获得最佳的患者护理.
更多相关视频
00:04A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
10.6K
08:44Preparation, Administration, and Assessment of In Vivo Tissue-Specific Cellular Uptake of Fluorescent Dye-Labeled Liposomes
Published on: July 30, 2020
4.4K
相关概念视频
01:19Pharmacovigilance
810
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...
810
01:25Drug Regulation
1.3K
Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
1.3K