药品上市后临床安全性再评价医院集中监测方案的实施要点

发布时间：2018-04-21 00:14

本文选题：医院集中监测 + 上市后再评价　；参考：《中国中西医结合杂志》2017年05期

【摘要】：医院集中监测是指在一定的时间(数月或数年)、一定的范围内对某一医院或某一地区内所发生的不良事件/反应及药物利用作详细记录,以探讨不良事件/反应的发生规律。目前我国仍处于不良反应监测的初期阶段,集中监测的技术仍不成熟。结合河南中医药大学药学部主持参与的多项中药注射液上市后临床安全性再评价医院集中监测研究,总结医院集中监测方案的实施要点,以供参鉴。
[Abstract]:Centralized monitoring in hospital refers to the detailed recording of adverse events / reactions and drug use in a certain hospital or region within a certain range of time (months or years) in order to discuss the occurrence regularity of adverse events / reactions. At present, China is still in the initial stage of adverse reaction monitoring, centralized monitoring technology is still immature. Combined with the centralized monitoring research of the hospital after the clinical safety evaluation of many traditional Chinese medicine injection which was presided over by the Department of Pharmacy of Henan University of traditional Chinese Medicine, the main points of the implementation of the centralized monitoring scheme of the hospital were summarized in order to provide reference for reference.
【作者单位】：河南中医药大学第一附属医院心血管内科;天津中医药大学中医药研究院;
【基金】：国家重点基础研究发展计划(973)(No.2015CB554401) 河南省创新型科技团队(No.C20130050) 河南省高校科技创新团队支持计划(No.13IRTSTHN012)
【分类号】：R95

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