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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。
Centralized monitoring of hospitals refers to detailed recording of adverse events / reactions and drug use in a hospital or a certain area within a certain period of time (months or years) to explore adverse events / reactions The law of occurrence. At present, China is still in the initial stage of adverse reaction monitoring, and the technology of centralized monitoring is still immature. Combined with the pharmacy department of Henan University of Chinese Medicine under the auspices of a number of Chinese medicine injection clinical safety re-evaluation of the hospital centralized monitoring and research, summarize the implementation of the hospital centralized monitoring program points for reference.