藥品不良反應(yīng)流行病學(xué)智能分析系統(tǒng)的建立及應(yīng)用
發(fā)布時間：2018-09-13 07:59
【摘要】：目的：探討重慶市藥品不良反應(yīng)/事件（ADR/ADE）發(fā)生的特點(diǎn)與規(guī)律，為加強(qiáng)藥品安全監(jiān)測、指導(dǎo)臨床合理用藥提供參考和依據(jù)，同時為藥品監(jiān)管部門提供決策依據(jù)。 方法：以重慶市藥品不良反應(yīng)監(jiān)測中心收集的ADR/ADE數(shù)據(jù)資料作為數(shù)據(jù)源，基于商業(yè)智能技術(shù)，構(gòu)建藥品不良反應(yīng)智能分析系統(tǒng)；應(yīng)用智能分析系統(tǒng)，對重慶市2008～2012年藥物所致的65900例ADR/ADE進(jìn)行藥物流行病學(xué)研究，再分別對2012年頭孢菌素類藥及2010年～2013年6月熱毒寧注射液引發(fā)的ADR/ADE進(jìn)行智能分析。 結(jié)果：①開發(fā)了具有各種匯總、統(tǒng)計、查詢、更新等功能的智能分析系統(tǒng)；②65900例ADR/ADE報告中，以60歲以上的老年患者發(fā)生率較高；靜脈給藥引發(fā)的ADR/ADE最多；ADR/ADE涉及的藥品以抗微生物藥最多，其次是中成藥；ADR/ADE主要累及器官和臨床表現(xiàn)為消化系統(tǒng)癥狀、皮膚及其附件損害及全身癥狀；醫(yī)療機(jī)構(gòu)為上報主體；③3394例頭孢菌素類藥引發(fā)的ADR/ADE報告中，10歲以下的兒童發(fā)生率較高；19.27%是由頭孢曲松引發(fā)的；嚴(yán)重的ADR/ADE(包括新的嚴(yán)重的)有119例，以過敏性休克最常見；④125例熱毒寧注射液發(fā)生ADR/ADE的患者中，29例ADE（23.20%）為超適應(yīng)證用藥引起；男性81例（64.8%），女性44例（35.2%）；2歲以下嬰幼兒發(fā)生率較高（48.0%）；89.6%的患者在用藥30min內(nèi)發(fā)生ADR/ADE；共發(fā)生ADR/ADE207例次，73.9%為藥物性皮疹、瘙癢等皮膚及其附件損害，20.3%為新的ADR。 結(jié)論：智能分析系統(tǒng)能夠有效地提高ADR/ADE報告信息的利用率，多層次、多角度地挖掘潛在的有價值的信息，具有良好的應(yīng)用前景；臨床應(yīng)重視抗微生物藥與中成藥ADR/ADE的監(jiān)測工作，尤其是以頭孢曲松為主的頭孢菌素類藥物，并密切關(guān)注熱毒寧注射液在用藥30min內(nèi)的臨床表現(xiàn)，規(guī)范臨床用藥，以減少ADR/ADE的發(fā)生，保證用藥安全、有效。
[Abstract]:Objective: to explore the characteristics and regularity of adverse drug reactions / events (ADR/ADE) in Chongqing, to provide reference and basis for strengthening drug safety monitoring and guiding rational drug use in clinic, and to provide decision basis for drug supervision department. Methods: based on business intelligence technology, an intelligent analysis system of adverse drug reactions was constructed based on ADR/ADE data collected by Chongqing ADR Monitoring Center. 65900 cases of ADR/ADE caused by drugs in Chongqing from 2008 to 2012 were studied by pharmacoepidemiology. The ADR/ADE induced by cephalosporins in 2012 and Reduning injection from 2010 to June 2013 were analyzed intelligently. Results the intelligence analysis system with various functions such as collection, statistics, query, update and so on was developed by 1: 1. Among the 265 900 cases of ADR/ADE reports, the incidence of ADR/ADE was higher in the elderly patients over 60 years old, and the ADR/ADE caused by intravenous administration was the most. The main drugs involved in ADR/ADE were antimicrobial drugs, followed by the Chinese patent medicine ADR / ADE, which mainly involved organs and clinical manifestations as digestive system symptoms, skin and its appendages damage and systemic symptoms, medical institutions as the main reporting body; In 33394 cases of ADR/ADE caused by cephalosporins, the incidence of children under 10 years of age was 19.27%, severe ADR/ADE (including new severe) was 119 cases, and anaphylactic shock was the most common. Of the 4125 patients with ADR/ADE, 29 cases (23.20%) were caused by ADE, and 81 cases (64.8%) were males and 44 cases (35.2%) were females. The incidence of ADR/ADE; in children under 2 years of age (48.0%) was higher (48.0%) than that in 30min patients (89.6%). A total of 73.9% of the ADR/ADE207 cases were drug-induced rash, pruritus and other skin and adnexal lesions. 20.3% of the cases were new ADR.. Conclusion: the intelligent analysis system can effectively improve the utilization rate of ADR/ADE report information, excavate the potential valuable information from multiple levels and angles, and have a good application prospect. The monitoring of ADR/ADE of antimicrobial drugs and proprietary Chinese medicines should be paid more attention to in clinic. Especially ceftriaxone mainly cephalosporins, and pay close attention to the clinical manifestation of Reduning injection in 30min, standardize the clinical use, in order to reduce the occurrence of ADR/ADE, ensure the safety and effectiveness of drug use.
【學(xué)位授予單位】：重慶醫(yī)科大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2014
【分類號】：R969.3
本文編號：2240542
[Abstract]:Objective: to explore the characteristics and regularity of adverse drug reactions / events (ADR/ADE) in Chongqing, to provide reference and basis for strengthening drug safety monitoring and guiding rational drug use in clinic, and to provide decision basis for drug supervision department. Methods: based on business intelligence technology, an intelligent analysis system of adverse drug reactions was constructed based on ADR/ADE data collected by Chongqing ADR Monitoring Center. 65900 cases of ADR/ADE caused by drugs in Chongqing from 2008 to 2012 were studied by pharmacoepidemiology. The ADR/ADE induced by cephalosporins in 2012 and Reduning injection from 2010 to June 2013 were analyzed intelligently. Results the intelligence analysis system with various functions such as collection, statistics, query, update and so on was developed by 1: 1. Among the 265 900 cases of ADR/ADE reports, the incidence of ADR/ADE was higher in the elderly patients over 60 years old, and the ADR/ADE caused by intravenous administration was the most. The main drugs involved in ADR/ADE were antimicrobial drugs, followed by the Chinese patent medicine ADR / ADE, which mainly involved organs and clinical manifestations as digestive system symptoms, skin and its appendages damage and systemic symptoms, medical institutions as the main reporting body; In 33394 cases of ADR/ADE caused by cephalosporins, the incidence of children under 10 years of age was 19.27%, severe ADR/ADE (including new severe) was 119 cases, and anaphylactic shock was the most common. Of the 4125 patients with ADR/ADE, 29 cases (23.20%) were caused by ADE, and 81 cases (64.8%) were males and 44 cases (35.2%) were females. The incidence of ADR/ADE; in children under 2 years of age (48.0%) was higher (48.0%) than that in 30min patients (89.6%). A total of 73.9% of the ADR/ADE207 cases were drug-induced rash, pruritus and other skin and adnexal lesions. 20.3% of the cases were new ADR.. Conclusion: the intelligent analysis system can effectively improve the utilization rate of ADR/ADE report information, excavate the potential valuable information from multiple levels and angles, and have a good application prospect. The monitoring of ADR/ADE of antimicrobial drugs and proprietary Chinese medicines should be paid more attention to in clinic. Especially ceftriaxone mainly cephalosporins, and pay close attention to the clinical manifestation of Reduning injection in 30min, standardize the clinical use, in order to reduce the occurrence of ADR/ADE, ensure the safety and effectiveness of drug use.
【學(xué)位授予單位】：重慶醫(yī)科大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2014
【分類號】：R969.3
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