使用药监数据库估计与草药相关的不良事件:系统审查和元分析
Chuenjid Kongkaew1,2, Dang Thuc Anh Phan1,3, Prathan Janusorn1,4
1Centre for Safety and Quality in Health, Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand.
JMIR public health and surveillance
|August 29, 2024
概括
草药的不良事件 (AE) 显示出不同的报告率,受报告来源的影响. 标准化报告系统对于可靠的药监数据至关重要.
科学领域:
- 药物监督 药物监督 药物监督
- 草药的安全性 草药的安全性
- 系统审查是系统的审查.
背景情况:
- 草药 (HM) 在全球广泛使用,但它们的安全性和相关不良事件 (AE) 往往没有得到充分报道.
- 以前的研究表明,潜在的副作用包括肝毒性和功能衰竭,但与HM相关的副作用的总体患病率被认为很低.
- 没有全面的系统审查和元分析专门使用药物监督 (PV) 数据库分析HM AEs.
研究的目的:
- 使用药监数据库估计与草药相关的不良事件 (AE) 报告率.
- 批判性地评估HMs报告的AE中提供的数据的完整性和细节性.
主要方法:
- 一个系统的审查和对研究的元分析发表到2023年12月,搜索MEDLINE/PubMed,SCOPUS,EMBASE和CINAHL.
- 利用DerSimonian-Laird随机效应模型进行数据聚合,使用子组和元回归分析来调查异质性.
- 采用Crombie的检查清单来评估所包含的26项研究中的偏见风险.
主要成果:
- 对HM的AE报告率有很大的差异,从0.03%到29.84%不等,中位数的综合估计为1.42%.
- 报告率与报告者的来源有显著的关联 (P=.01).
- 包含的研究缺乏对疑似草药产品的全面细节,通常只披露主要成分,并省略其他潜在有害成分.
结论:
- 这一系统性审查强调了HM AE报告率的相当大的变化,受报告人群的影响.
- 消费者报告系统的标准化,包括表格,教育和后续工作,对于提高HM安全监测的光伏数据的质量和实用性至关重要.
- 有效监测和报告HMAE需要患者,制造商,医疗保健提供者和监管机构之间的协作努力.
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