本文選題：大數(shù)據(jù) + 藥品安全��； 參考：《藥物流行病學雜志》2016年07期

【摘要】：藥品安全性日趨成為威脅人類生命和健康的嚴重公共衛(wèi)生問題,關系到公眾生命健康權(quán)益的維護和保障,關系到經(jīng)濟健康發(fā)展和社會和諧穩(wěn)定,關系到全面建設小康社會宏偉目標的實現(xiàn),預防和控制藥源性損害刻不容緩�，F(xiàn)行國內(nèi)外藥品不良反應監(jiān)測是以自發(fā)報告的被動監(jiān)測為主,容易發(fā)生漏報,且由于缺少用藥基礎人群數(shù)量,無法計算不良反應發(fā)生率;而流行病學專題調(diào)查為主的主動監(jiān)測花費通常較高,而且費時、費力,時效性較差。歐美等發(fā)達國家已建立基于大數(shù)據(jù)的藥品上市后安全性主動監(jiān)測系統(tǒng)并取得顯著的效果。隨著相關政策法規(guī)的頒布和實施,以及醫(yī)療數(shù)據(jù)的不斷積累和質(zhì)量提升,我國已逐漸具備開展藥品安全大數(shù)據(jù)主動監(jiān)測研究的條件�；诖笠�(guī)模電子醫(yī)療數(shù)據(jù)開展藥品不良反應主動監(jiān)測模式研究將為實現(xiàn)對藥品安全更及時、有效地監(jiān)測開辟新的途徑和方法。
[Abstract]:Drug safety has increasingly become a serious public health problem threatening human life and health, related to the protection and protection of the public's rights and interests of life and health, and related to the healthy development of economy and social harmony and stability.Related to the realization of the grand goal of building a well-off society in an all-round way, it is urgent to prevent and control the drug source damage.The current monitoring of adverse drug reactions at home and abroad is mainly passive monitoring, which is easy to fail to report, and it is impossible to calculate the incidence of adverse reactions because of the lack of the number of people on the basis of drug use.The active surveillance based on epidemiological survey is usually expensive, time-consuming, laborious and inefficient.Developed countries, such as Europe and America, have established the active monitoring system of drug safety after marketing based on big data and achieved remarkable results.With the promulgation and implementation of relevant policies and regulations, as well as the continuous accumulation of medical data and the improvement of quality, China has gradually possessed the conditions for active monitoring and research of drug safety big data.The research on active monitoring mode of adverse drug reactions based on large scale electronic medical data will open up a new way and method for the timely and effective monitoring of drug safety.
【作者單位】： 北京大學公共衛(wèi)生學院流行病與衛(wèi)生統(tǒng)計學系;
【基金】：國家自然科學基金項目(編號:81473067) 中國博士后科學基金項目(編號:2015M570905)
【分類號】：R954

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