本文選題：醫(yī)院集中監(jiān)測 + 上市后再評價��； 參考：《中國中西醫(yī)結(jié)合雜志》2017年05期

【摘要】：醫(yī)院集中監(jiān)測是指在一定的時間(數(shù)月或數(shù)年)、一定的范圍內(nèi)對某一醫(yī)院或某一地區(qū)內(nèi)所發(fā)生的不良事件/反應(yīng)及藥物利用作詳細(xì)記錄,以探討不良事件/反應(yīng)的發(fā)生規(guī)律。目前我國仍處于不良反應(yīng)監(jiān)測的初期階段,集中監(jiān)測的技術(shù)仍不成熟。結(jié)合河南中醫(yī)藥大學(xué)藥學(xué)部主持參與的多項(xiàng)中藥注射液上市后臨床安全性再評價醫(yī)院集中監(jiān)測研究,總結(jié)醫(yī)院集中監(jiān)測方案的實(shí)施要點(diǎn),以供參鑒。
[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.
【作者單位】： 河南中醫(yī)藥大學(xué)第一附屬醫(yī)院心血管內(nèi)科;天津中醫(yī)藥大學(xué)中醫(yī)藥研究院;
【基金】：國家重點(diǎn)基礎(chǔ)研究發(fā)展計(jì)劃(973)(No.2015CB554401) 河南省創(chuàng)新型科技團(tuán)隊(duì)(No.C20130050) 河南省高�？萍紕�(chuàng)新團(tuán)隊(duì)支持計(jì)劃(No.13IRTSTHN012)
【分類號】：R95

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