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与药物相关的产后出血:基于FAERS数据库的全面不成比例分析

Yongjin Xie¹, Jintuo Zhou², Yingling Xie³

¹Department of Obstetrics and Gynecology, College of Clinical Medicine for Obstetrics & Gynecology and Pediatrics, Fujian Maternity and Child Health Hospital, Fujian Medical University, Fuzhou, Fujian, 350001, China.

Naunyn-Schmiedeberg's archives of pharmacology

|September 9, 2025

概括

这项研究使用FDA数据确定了32种与分娩后出血 (PPH) 相关的药物,包括催产素,丁诺普罗斯和米索普罗斯托. 调查结果强调需要监测药物诱导的PPH风险,即使是长期的.

科学领域:

药物监督药物监督药物监督
产科产科产科产科产科
药品安全药品安全

背景情况:

产后出血 (PPH) 是一个严重的产科并发症,具有显著的孕产妇发病率和死亡率.
确定PPH的阳性致病原因对于改善患者的治疗结果和制定有针对性的预防策略至关重要.

研究的目的:

使用FDA不良事件报告系统 (FAERS) 数据库识别与PPH相关的药物.
为有针对性的预防与药物相关的PPH风险因素提供科学证据.
分析与PPH相关的药物不良事件 (ADEs) 的时间发生.

主要方法:

从2004Q1到2025Q1的FAERS数据的不成比例分析.
使用统计方法,包括报告几率比率 (ROR),比例报告比率 (PRR),信息组件 (IC) 和实证贝叶斯几何平均值 (EBGM) 来进行信号检测.
确定了与PPH具有统计学意义的关联的药物事件组合.

主要成果:

总共分析了1078份与PPH相关的ADEs报告,97.96%导致严重后果.
在14个系统中32种药物符合该研究的信号检测标准.
催产素,丁诺普罗斯和弥索普罗斯是与PPH相关的前三种药物,所有这些药物都常用于分娩诱导或PPH管理.
在药物服用后的第一个月和最多360天内观察到显著的PPH事件,这表明长期风险.

结论:

这项研究成功地识别和排名了与PPH相关的药物,强调了药物监督的重要性.
这些发现强调了在产周期间需要个性化监测策略的需要.
与怀孕期间使用的慢性疾病药物相关的长期PPH风险需要进一步关注和研究.

关键词:

不良事件是不良事件.不成比例的分析分析.公平的人是公平的.产后出血产后出血产后出血

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