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了解塞纳风险:来自FDA不良事件报告系统的证据

Jingyi Zhao¹, Yan Chen¹, Chao Du²

¹Hebei (Chengde) Industrial Technology Institute of Chinese Medicinal Materials, Chengde Medical University, Chengde, 067000, China.

Journal of ethnopharmacology

|January 25, 2026

概括

塞纳的使用可能与免疫系统障碍有关,大多数不良事件 (AE) 报告在女性和老年人中. 需要进一步的研究来了解这些塞纳的副作用.

科学领域:

药物监督和草药安全草药安全
临床药理学临床药理学
药品安全监督药品安全监督

背景情况:

塞纳是一种广泛使用的豆类药用植物,具有传统的治疗性质,包括药作用.
尽管它被广泛使用,但塞纳的安全性概况和潜在的不良事件 (AEs) 尚未完全理解.
药监数据对于评估草药药物的安全性至关重要,如 senna.

研究的目的:

分析2004年至2024年在FDA不良事件报告系统 (FAERS) 数据库中报告的与塞纳相关的不良事件 (AE).
评估这些AE的证据的强度,并确定潜在的风险因素.
评估塞纳使用与报告的不良事件之间的因果关系.

主要方法:

从FAERS数据库中分析了超过1800万份与塞纳有关的报告.
使用ROR,PRR,IC和EBGM算法进行不成比例分析.
后勤回归和时间开始分析用于风险因素识别;修改了Bradford Hill因果关系评估标准.

主要成果:

报告的副作用的显著增加被观察到,免疫系统障碍是最常见的系统器官类 (SOC).
女性 (62.86%) 和60岁以上的人 (32.09%) 受影响最多,平均发病时间为4天.
先进的年龄,女性性别,以及同时使用酸和托法西替尼酸盐被确定为免疫系统疾病的危险因素.

结论:

塞纳的使用可能与免疫系统障碍有关,需要仔细的临床监测.
这些发现表明,基于经过修改的布拉德福德希尔标准,可能存在因果关系.
需要进一步研究 senna 诱导的不良反应的机制.

关键词:

药物不良反应药物不良反应布拉德福德山的标准布拉德福德山的标准公平的人是公平的.药物监督药物监督药物监督塞纳塞纳塞纳塞纳自发的报告自发报告.

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