一个现实世界药监案例/非案例研究FDA不良事件报告系统事件对曼尼托尔
Zhi Jin1, Yu Liu2, Zongren Zhao2
1Department of Neurology, Shanghai Fifth People's Hospital, Fudan University, Shanghai, China.
Expert opinion on drug safety
|April 10, 2025
概括
这项药监测研究确定了透性利尿剂曼尼托尔的安全信号. 关键的不良事件包括高度,高度和高度,强调需要仔细监测曼尼托尔.
科学领域:
- 药物监督 药物监督 药物监督
- 临床药理学 临床药理学
- 药品安全 药品安全
背景情况:
- 曼尼托尔是一种透性利尿剂,通常用于水和内高血压.
- 与曼尼托尔相关的不良事件 (AE) 需要持续的安全监测.
- 这项研究旨在利用现实数据确定曼尼托尔的潜在安全信号.
研究的目的:
- 使用FDA不良事件报告系统 (FAERS) 数据库分析与曼尼托尔相关的不良事件 (AE).
- 识别和评估与曼尼托尔使用相关的潜在安全信号.
- 评估报告的曼尼托尔副作用的频率,严重程度和临床相关性.
主要方法:
- 一个回顾性药监测研究设计.
- 使用FAERS数据从2013年第一季度到2023年第四季度.
- 采用信号检测算法,如报告几率比率 (ROR) 和比例报告比率 (PRR).
主要成果:
- 在3900多万份报告中分析了1014份提到曼尼托的报告.
- 确定了"高位状态" (ROR=665.98),"高血"和"高血" (ROR=25.18) 作为重要的安全信号.
- 副作用经常涉及和尿路疾病 (295例) 和皮肤/皮下组织疾病 (371例).
结论:
- 由于已识别的安全信号,对曼尼托尔使用的警监测至关重要.
- 需要进一步的研究来阐明意想不到的AE的机制.
- 建立对曼尼托尔的全面安全概况仍然是一个持续的优先事项.
相关概念视频
Pharmacovigilance
753
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...
753
Drug 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
Clinical Trials: Overview
2.5K
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...
2.5K
Local Anesthetics: Adverse Effects
377
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...
377
Chronopharmacokinetics: Circadian Rhythms and Influence on Drug Response
32
Circadian rhythms are cyclic changes that are crucial in plasma drug concentrations. Various standard circadian parameters, including core body temperature, heart rate, and other cardiovascular factors, directly impact disease states and the therapeutic response to drug therapy.
The time of drug administration is an important factor to consider, as it can influence the toxic dose of a drug. For example, a study conducted by Prins et al. in 1997 examined the effects of the timing of...
The time of drug administration is an important factor to consider, as it can influence the toxic dose of a drug. For example, a study conducted by Prins et al. in 1997 examined the effects of the timing of...
32
Antiepileptic Drugs: Potassium Channel Activators
134
Ezocgabine or retigabine, an antiepileptic drug of remarkable efficacy, has revolutionized the management of seizures. It is a potassium channel activator, explicitly targeting the family of Q subtype potassium channels. It enhances the transmembrane potassium currents, regulating neuronal excitability. This action stabilizes the resting membrane potential, a pivotal factor in mitigating the hyperexcitability that characterizes epilepsy.
Ezogabine has gained approval as an adjunctive treatment...
Ezogabine has gained approval as an adjunctive treatment...
134


