【摘要】：藥品不良反應(yīng)(Adverse Drug Reaction,簡(jiǎn)稱(chēng)ADR)是指在按規(guī)定劑量正常應(yīng)用藥品的過(guò)程中產(chǎn)生的有害而非所期望的、與藥品應(yīng)用有因果關(guān)系的反應(yīng),藥品不良反應(yīng)一般可分為副作用、毒性反應(yīng)、過(guò)敏反應(yīng)和繼發(fā)感染四大類(lèi),在現(xiàn)實(shí)生活中,藥品不良反應(yīng)的發(fā)生率是相當(dāng)高的,特別是在長(zhǎng)期使用或用藥量較大時(shí),情況更為嚴(yán)重甚至出現(xiàn)嚴(yán)重的毒副反應(yīng),ADR報(bào)告和監(jiān)測(cè)是指藥品不良反應(yīng)的發(fā)現(xiàn)、報(bào)告、評(píng)價(jià)和控制的過(guò)程,國(guó)際上ADR監(jiān)測(cè)的主要方法有自發(fā)呈報(bào)系統(tǒng)(SRS)、處方事件監(jiān)測(cè)(PEM)及醫(yī)院集中監(jiān)測(cè)系統(tǒng)等三種。 本文針對(duì)我國(guó)目前ADR監(jiān)測(cè)自發(fā)呈報(bào)模式存在的漏報(bào)率高、計(jì)算ADR發(fā)生率困難、報(bào)告隨意性強(qiáng)、報(bào)告信息不完整難以確定因果關(guān)系等問(wèn)題和局限性,結(jié)合國(guó)家藥監(jiān)部門(mén)對(duì)上市后藥品安全監(jiān)管的需求,研究開(kāi)發(fā)“醫(yī)院藥品不良反應(yīng)集中監(jiān)測(cè)與評(píng)價(jià)系統(tǒng)”,通過(guò)與協(xié)作醫(yī)院HIS系統(tǒng)的信息集成,實(shí)現(xiàn)醫(yī)療機(jī)構(gòu)內(nèi)部ADR信息管理、重點(diǎn)監(jiān)測(cè)藥品安全性再評(píng)價(jià)管理、ADR處方事件監(jiān)測(cè)管理及與廣東省ADR信息管理系統(tǒng)的信息智能交換管理等功能,從而為探索我國(guó)醫(yī)院ADR信息及重點(diǎn)監(jiān)測(cè)藥品信息的自動(dòng)采集、分析、評(píng)價(jià)、預(yù)警、反饋及服務(wù)的有效方法進(jìn)行有益地嘗試。 本文研究開(kāi)發(fā)工作在探索適合我國(guó)國(guó)情的藥品ADR醫(yī)院集中監(jiān)測(cè)、處方事件監(jiān)測(cè)與自發(fā)呈報(bào)監(jiān)測(cè)等方法有機(jī)結(jié)合與應(yīng)用方面有所創(chuàng)新,研究成果將為我國(guó)逐步建設(shè)和推廣應(yīng)用兼顧藥品ADR監(jiān)測(cè)、重點(diǎn)藥品安全性再評(píng)價(jià)及區(qū)域藥物流行病學(xué)研究等功能的綜合服務(wù)平臺(tái)打下良好基礎(chǔ),從而為我省乃至我國(guó)全面提升上市后藥品安全監(jiān)管能力和有效促進(jìn)醫(yī)療機(jī)構(gòu)安全合理用藥服務(wù)。
[Abstract]:Adverse Drug Reaction (ADR) refers to the adverse reactions produced in the course of normal use of drugs according to the prescribed dosage rather than expected, which are causal to the use of drugs. ADR can be generally divided into four categories: side effects, toxic reactions, allergic reactions and secondary infections. In real life, drugs ADR reporting and monitoring refers to the process of discovery, reporting, evaluation and control of adverse drug reactions. The main methods of ADR monitoring in the world are spontaneous reporting system (SRS), prescription event monitoring. There are three kinds of measurement system (PEM) and centralized hospital monitoring system.
Aiming at the problems and limitations of the current spontaneous reporting mode of ADR monitoring in China, such as high rate of omission, difficulty in calculating the incidence of ADR, strong randomness in reporting, incomplete information in reporting, and difficulty in determining the causality, this paper studies and develops the "centralized monitoring of adverse drug reactions in hospitals" according to the requirements of the state drug regulatory department for drug safety supervision after listing. Through information integration with HIS system of cooperative hospital, the functions of ADR information management in medical institutions, drug safety reappraisal management, ADR prescription event monitoring management and intelligent information exchange management with ADR information management system of Guangdong Province are realized, so as to explore ADR information and key monitoring of hospitals in China. Effective methods for automatic collection, analysis, evaluation, early warning, feedback and service of drug information are beneficial attempts.
The research and development work in this paper has made some innovations in exploring the organic combination and application of drug ADR hospital centralized surveillance, prescription event surveillance and voluntary reporting surveillance. The research results will give consideration to drug ADR surveillance, key drug safety reassessment and regional drug epidemic in China. The comprehensive service platform of research and other functions lays a good foundation for our province and even our country to comprehensively enhance the post-marketing drug safety supervision ability and effectively promote the safe and rational drug use service of medical institutions.
【學(xué)位授予單位】：廣東工業(yè)大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2014
【分類(lèi)號(hào)】：R95

【引證文獻(xiàn)】

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1 李麗婭;;基層醫(yī)院藥品不良反應(yīng)監(jiān)測(cè)中存在的問(wèn)題探討[J];世界最新醫(yī)學(xué)信息文摘;2016年94期

2 謝瑩霞;劉源;;利用醫(yī)院集中監(jiān)測(cè)藥物不良反應(yīng)管理系統(tǒng)適時(shí)監(jiān)測(cè)藥物性肝損害[J];中國(guó)衛(wèi)生產(chǎn)業(yè);2016年29期

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1 陸文喬;區(qū)域食品安全檢測(cè)及風(fēng)險(xiǎn)預(yù)警系統(tǒng)設(shè)計(jì)與實(shí)現(xiàn)[D];廣東工業(yè)大學(xué);2015年

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本文編號(hào)：2194824