与环胺相关的不良事件:使用FDA不良事件报告系统的药监测研究
Hui Zhang1, Minghao Lin1, Dexi Zhao1,2
1Changchun University of Chinese Medicine, Changchun, China.
PloS one
|January 6, 2026
概括
循环胺 (CHOP) 化疗可以引起严重的不良事件,特别是血液和淋巴系统疾病. 建议高风险患者谨慎使用,特别是在与放射治疗相结合时,因为血液性囊炎等风险增加.
科学领域:
- 在瘤学瘤学.
- 药物监督 药物监督 药物监督
- 临床药理学 临床药理学
背景情况:
- 环胺 (CHOP) 是一种广泛用于各种癌症的化剂.
- 它的机制涉及干扰DNA复制和转录以抑制瘤细胞增殖.
- 现实世界的数据分析对于理解其安全概况至关重要.
研究的目的:
- 通过使用真实世界的数据来评估与环胺 (CHOP) 相关的不良事件 (AE).
- 识别潜在的安全信号和意外的不良反应.
- 评估CHOP与其他疗法结合使用的影响.
主要方法:
- 从FAERS数据库 (2004-2024) 中分析了3625份不良事件报告.
- 包括医疗保健专业人员提交的CHOP是主要可疑药物的报告.
- 使用了四种信号检测方法:ROR,PRR,BCPNN和MGPS.
主要成果:
- 在25个系统器官类 (SOC) 中确定了重要的信号.
- 最突出的SOC信号是"血液和淋巴系统疾病" (ROR = 6.64).
- 一个有意义的首选术语 (PT) 信号是"高级B细胞淋巴瘤Burkitt类淋巴瘤复发" (ROR = 613.63).
结论:
- 证实了已知的安全问题,并确定了七个意想不到的非标签的副作用.
- 当CHOP与放射治疗相结合时,观察到严重的AE风险增加,如出血性囊炎.
- 强调需要谨慎对待具有特定病史的高风险患者.
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
Drug Regulation
2.7K
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...
2.7K
Therapeutic Drug Monitoring: Affecting Factors
196
Therapeutic Drug Monitoring (TDM) is the clinical practice of measuring specific drug levels in a patient's blood or body tissues to manage and optimize therapy. TDM is crucial for drugs with narrow therapeutic windows, like warfarin and phenytoin, where incorrect doses can lead to treatment failure or severe side effects. This monitoring ensures the dosage administered is within a safe and effective range. The factors affecting therapeutic drug monitoring include:Patient-Specific Factors:a.
196
Drug Accumulation During Multiple Dosing: Intermittent IV Infusions
227
Intermittent intravenous (IV) infusion is a method of drug administration where medications are delivered over short infusion periods followed by intervals of no drug delivery. This approach helps to prevent sustained high drug concentrations in the bloodstream, reducing the risk of adverse effects associated with prolonged exposure. Unlike continuous infusion, steady-state concentrations may not be achieved during a single dosing cycle but can be reached through repeated...
227
FDA Approved Drugs: Changes to Approved Drugs
239
Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
239
Desensitization and Tachyphylaxis
3.0K
Tachyphylaxis is described as a rapid decrease in response to a drug after repeated or continuous administration of the same drug dose. It is a phenomenon where the body becomes less responsive to a particular substance or intervention over time, requiring higher doses or stronger interventions to achieve the same effect. It results from adaptive changes in the body's receptors, signaling pathways, or physiological processes that occur in response to prolonged exposure to a stimulus.
3.0K

