揭露隐藏的风险:从FAERS数据库分析与益生菌相关的药物不良反应 - 质量改进研究
Yan Jiao1, Zhi-Cheng Liu2, Ya-Hui Liu1
1Department of Hepatobiliary and Pancreatic Surgery, General Surgery Center, The First Hospital of Jilin University, Changchun, Jilin, China.
International journal of surgery (London, England)
|May 28, 2025
概括
益生菌可能导致药物不良反应 (ADR),包括胃肠道问题和焦虑. 这项研究分析了FAERS数据以确定这些风险,提高对临床使用益生菌安全性的理解.
科学领域:
- 微生物学 微生物学
- 药物监督 药物监督 药物监督
- 胃肠病学 胃肠病学
背景情况:
- 益生菌通过减少感染和炎症,在腹部手术中显示出治疗潜力.
- 然而,益生菌与不良药物反应 (ADRs) 有关.
- 美国食品和药物管理局的不良事件报告系统 (FAERS) 对制药监测非常有价值.
研究的目的:
- 分析与益生菌使用相关的ADR.
- 通过识别潜在风险,指导安全的临床治疗.
主要方法:
- 从FAERS数据库中对益生菌相关的ADR报告进行了回顾性分析.
- 使用报告几率比率 (ROR),比例报告比率 (PRR) 和其他方法进行统计分析.
- 在除重复后包含超过800万条记录.
主要成果:
- 鉴定了55种与益生菌相关的不良药物反应 (ADR).
- 对于胃肠道疾病,如腹部不适,膨胀,膨胀和疼痛,发现了重要的关联.
- 注意到与神经和精神效应的潜在关联,如焦虑,兴奋和震.
结论:
- 该研究提供了益生菌的全面安全概况,包括新的副作用.
- 需要持续的警和进一步的调查来确认发现.
- 对益生菌安全性的更好理解对于临床应用至关重要.
相关概念视频
01:19Pharmacovigilance
1.0K
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...
1.0K
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
184
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
184