与儿童和青少年药物相关的严重皮肤不良反应:基于FDA不良事件报告系统数据库的药监测研究
Yaping Xiao1,2, Hu Guo1,2, Lijuan Deng1,2
1Department of Pharmacy, Chongqing University Three Gorges Hospital, 165 Xincheng Road, Wanzhou District, Chongqing, 404000, China.
International journal of clinical pharmacy
|December 3, 2025
概括
儿童和青少年的严重皮肤不良反应 (SCAR) 与抗和抗感染药物有关,显示出高的住院和死亡率. 加强儿科药物监测对于预防至关重要.
科学领域:
- 儿科药理学 儿科药理学
- 药物监督 药物监督 药物监督
- 药品安全 药品安全
背景情况:
- 严重的皮肤不良反应 (SCAR) 由于其独特的生理和免疫特征,对儿童和青少年构成重大风险.
- 关于儿科人口中药物特异性SCAR模式的有限大规模数据存在,阻碍了针对性的安全干预.
研究的目的:
- 分析儿童患者中SCARs的流行病学,临床表现和药物相关性.
- 通过FDA不良事件报告系统 (FAERS) 在儿童和青少年中识别SCARs的安全信号.
主要方法:
- 通过使用标准化MedDRA查询 (SMQ) 从FAERS (Q1 2004Q2 2024) 获取儿科SCAR报告 (≤18岁).
- 使用多个不成比例分析 (ROR,PRR,BCPNN,MGPS,EBGM) 来检测安全信号.
- 将已识别的信号与现有的FDA儿科药物标签进行比较.
主要成果:
- 分析了7183份儿科SCAR报告,随着时间的推移趋势不断增加,主要是青少年和学龄儿童.
- 最常见的是带有异敏性和全身症状 (DRESS),史蒂文斯-约翰逊综合征 (SJS) 和有毒表皮解体 (TEN) 的药物反应.
- 观察到高住院率 (64.5%) 和死亡率 (6.3%);82.7%的病例发生在药物暴露后的30天内.
- 对38种药物,包括拉莫特里金和类药物,发现了积极的安全信号;四种药物在儿科标签上缺乏相应的警告.
结论:
- 儿科SCARs表现出不同的模式,其特点是严重的结果和与抗和抗感染药物的关联.
- 加强儿科药物监测系统和实施风险管理策略对于预防SCAR至关重要.
- 基因型导向的处方可能为未来的儿童群体减轻SCAR风险提供一种方法.
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
Allergic Drug Reactions
1.3K
Allergic reactions related to drugs are hypersensitivity responses driven by the immune system and bear no connection to the drug's therapeutic action. While drugs in isolation do not trigger an immune response, they can interact with endogenous proteins to form antigens. These antigens stimulate lymphocytes to produce antibodies. IgE-type antibodies attach themselves to mast cells. Upon subsequent exposure to the same stimulus, the antigen-antibody interaction is initiated, unleashing...
1.3K
Pharmacokinetics in Pediatric Patients: Drug Distribution
244
Drug distribution in the pediatric population exhibits unique challenges and considerations due to the physiological differences between children, particularly neonates and infants, and adults. A crucial aspect of pediatric pharmacology is understanding how these differences impact the pharmacokinetics of various drugs, necessitating age-specific dosing strategies to ensure efficacy and safety.Neonates and infants have a higher total body water content, ~75%–90% of their body weight,...
244
Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption
231
Understanding the physiological differences in the pediatric population is crucial for effective pharmacotherapy. Neonates, infants, and children exhibit significant variations in gastric pH, gastric emptying time, intestinal transit time, and biliary function. These variations profoundly affect oral drug absorption, necessitating a nuanced approach to pediatric dosing.Neonates present with a unique physiological profile, having a gastric pH greater than 4 and faster and more irregular gastric...
231
Drug Dosing: Infants and Children
234
Pediatric patient dosages diverge from adults due to disparities in body surface area, total body water, and extracellular fluid per kilogram of body weight. The dosing regimen considers the variations in pharmacokinetics and pharmacology across distinct age groups, encompassing preterm newborns, infants, young children, older children, and adolescents. Calculation of pediatric patient doses is predicated on determining body surface area, which exhibits a superior correlation with the child's...
234
Pharmacokinetics in Pediatric Patients: Drug Excretion
195
In pediatric medicine, understanding the renal function and drug elimination nuances is crucial for administering safe and effective treatments. Newborns, in particular, display markedly slower renal functions than adults, profoundly affecting how drugs are cleared from their bodies. This slower drug clearance requires clinicians to extend the dosing intervals for many medications to prevent drug accumulation and toxicity while ensuring therapeutic efficacy.One key area where these adjustments...
195


