抗生素诱导的肺栓塞:在食品和药物管理局的不良事件报告系统数据库中的不成比例分析,使用数据挖掘算法
Pramod Kumar Adusumilli1, Foujia Begum1, Ankita Ashok Sangnure1
1Department of Pharmacy Practice, Faculty of Pharmacy, M. S. Ramaiah University of Applied Sciences, Bengaluru, Karnataka, India.
Perspectives in clinical research
|January 27, 2025
概括
这项研究确定了与米诺环素,氨基醇和莫西素相关的肺栓塞 (PE) 风险增加. 需要进一步的研究来确认这些与抗生素相关的不良药物事件的因果关系.
科学领域:
- 药物监督 药物监督 药物监督
- 药品安全 药品安全
- 医疗数据采矿 医疗数据采矿
背景情况:
- 抗生素是经常被处方的药物.
- 不必要的抗生素使用引发了人们对潜在药物不良反应的担忧.
- 确定抗生素和不良事件之间的关联对于患者安全至关重要.
研究的目的:
- 调查抗生素使用与肺栓塞 (PE) 之间的关联.
- 分析美国食品和药物管理局不良事件报告系统 (FAERS) 数据库的潜在信号.
- 应用数据挖掘算法进行不成比例分析.
主要方法:
- 对FAERS数据 (2004 Q12022 Q3) 的回顾性案例/非案例不成比例性分析.
- 使用报告赔率比率 (ROR),比例报告比率 (PRR) 和信息组件 (IC) 来评估报告不成比例.
- 定义的阳性信号标准:ROR>1,Chi-square>4,PRR R2的情况>3,和IC>0.
主要成果:
- 分析了26,555,430个不良事件,包括80,809份肺栓塞报告.
- 确定了与PE相关的11种抗生素报告.
- 对于PE的显著报告信号发现了米诺环素 (ROR 2.87),氨基醇 (ROR 3.35) 和莫西素 (ROR 2.08).
结论:
- 报告肺栓塞的统计学上显著增加的风险与米诺环素,氨基醇和莫西素有关.
- 这些发现突出了针对特定抗生素的潜在安全问题.
- 从这些观测数据无法确定最终的因果关系.
关键词:
胺尼科尔 (Chloramphenicol) 是一种化学物质.美国食品和药物管理局对不良事件报告系统的数据库.米诺环素是什么意思?莫西弗洛克萨辛 (moxifloxacin) 是一种药物.肺栓塞 肺栓塞是一种肺栓塞.更多相关视频
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