本文關(guān)鍵詞： 藥品不良反應(yīng)/不良事件 藥品不良反應(yīng)綜合分析系統(tǒng) 藥品不良反應(yīng)報告分析 藥品不良反應(yīng)信號檢測　出處：《皖南醫(yī)學(xué)院》2014年碩士論文　論文類型：學(xué)位論文

【摘要】：目的：藥品不良反應(yīng)（adverse drug reaction，ADR）的監(jiān)測及分析工作是藥品上市后研究的重要內(nèi)容，我國對ADR的監(jiān)測工作現(xiàn)主要是通過自發(fā)呈報系統(tǒng)(spontaneous reporting system，，SRS)來完成的，在該系統(tǒng)的應(yīng)用過程中，出現(xiàn)了比如數(shù)據(jù)信息堆積、數(shù)據(jù)分類困難、數(shù)據(jù)信息不標(biāo)準(zhǔn)等問題，這些都使得藥品不良反應(yīng)/不良事件（adverse drug event，ADE）分析工作難以展開。需要有更智能化，便于操作的分析工具進(jìn)行不良反應(yīng)/事件報告分析。本研究計劃編制一個能進(jìn)行ADR報告數(shù)據(jù)標(biāo)準(zhǔn)化處理、不良反應(yīng)/事件報告綜合分析、不良反應(yīng)累及系統(tǒng)或器官分類分析及藥品不良反應(yīng)信號（Signal）挖掘為主要功能的開放性綜合評價系統(tǒng)，并將其推廣到各級藥學(xué)相關(guān)人員，從而實現(xiàn)不良反應(yīng)/事件報告數(shù)據(jù)分析和藥品不良反應(yīng)信號檢測的自動化、應(yīng)用的開放化、數(shù)據(jù)的共享化。 方法：該系統(tǒng)在Windows7的開發(fā)環(huán)境下，使用Java1.6， css，和hmtl語言編制，并以O(shè)racle11為數(shù)據(jù)庫和以Excel數(shù)據(jù)表為輸出，可建立局域網(wǎng)或互聯(lián)網(wǎng)開放式平臺，用戶借助IE瀏覽器即可進(jìn)行在線數(shù)據(jù)導(dǎo)入及分析。系統(tǒng)運用國內(nèi)外文獻(xiàn)常用的的不良反應(yīng)/事件報告（ADR/E）例次分析方式進(jìn)行綜合分析，并運用藥品不良反應(yīng)信號定量檢測的5種方法（PRR法、ROR法、MHRA法、YuleQ值法和BCPNN法）對不良反應(yīng)信號進(jìn)行檢測，檢測方法全面保證結(jié)果的可靠性。系統(tǒng)框架選用B/S（Browser/Server）構(gòu)架，以保證系統(tǒng)的開放性和用戶的多元性。 結(jié)果：本研究完成了藥物不良反應(yīng)綜合分析系統(tǒng)即ADRCAS（Adverse DrugReactions Comprehensive Analysis System）系統(tǒng)的建立工作，并為系統(tǒng)代碼向中國國家版保護(hù)中心申請獲得了獨立著作權(quán)；利用ADRCAS系統(tǒng)報告分析功能，可以完成不良反應(yīng)/事件報例次的綜合分析，分析內(nèi)容包括按年齡、性別、劑型、給藥途徑、轉(zhuǎn)歸情況、藥品類別、不良反應(yīng)發(fā)生部位等進(jìn)行的分類分析，并快速得到分析表格；利用ADRCAS系統(tǒng)信號檢測模塊，可使用5種常用不良反應(yīng)信號定量檢測方法檢測出藥品不良反應(yīng)信號強(qiáng)度以及其置信區(qū)間；ADRCAS系統(tǒng)完成了在黃山、淮北、蕪湖、合肥、南京、青島等地區(qū)的十幾家醫(yī)院和藥監(jiān)管理部門的推廣工作，并總計收集到近3萬例各個地區(qū)的ADR報告數(shù)據(jù)，并對相應(yīng)地區(qū)用戶發(fā)布了系統(tǒng)應(yīng)用帳號。 結(jié)論：經(jīng)過實際應(yīng)用，結(jié)果表明，ADRCAS系統(tǒng)實用性較強(qiáng)，開放性好，在很大程度上提高了藥品不良反應(yīng)分析的效率和準(zhǔn)確性，使不良反應(yīng)信號監(jiān)測系統(tǒng)化、方法規(guī)范化、指標(biāo)定量化、結(jié)果科學(xué)化。ADRCAS系統(tǒng)在醫(yī)院及藥管部門內(nèi)的推廣，可以提高藥學(xué)人員對不良反應(yīng)的分析能力，強(qiáng)化藥學(xué)人員對藥品不良反應(yīng)信號的檢測，提高醫(yī)療機(jī)構(gòu)以及藥品管理機(jī)構(gòu)的藥物警戒水平。
[Abstract]:Objective: the monitoring and analysis of adverse drug reactions (ADRs) is an important part of the post-marketing study of drugs. The monitoring of ADR in China is mainly accomplished through the spontaneous reporting system (SRS), which is used in the application of the system. Problems such as the accumulation of data information, the difficulty of data classification, and the lack of standard data information make it difficult to carry out the analysis of adverse drug reactions / adverse events, and need to be more intelligent. An easy-to-operate analysis tool for adverse reaction / event report analysis. This study plans to develop a standardized ADR reporting data processing, adverse reaction / event report comprehensive analysis, An open comprehensive evaluation system for the classification and analysis of adverse drug reactions involving systems or organs and signal mining for adverse drug reactions (ADRs) was developed and extended to pharmaceutical related personnel at all levels. In order to realize the analysis of adverse reaction / event report data and the detection of adverse drug reaction signal, the application is open and the data is shared. Methods: under the development environment of Windows7, the system was programmed with Java 1.6, CSS, and hmtl languages, Oracle11 as the database and Excel data table as the output. The open platform of LAN or Internet could be established. Users can import and analyze online data with the help of IE browser. The system uses ADR / E case analysis method which is commonly used in domestic and foreign literature for comprehensive analysis. Five methods of quantitative detection of adverse drug reaction signals were used to detect the adverse reaction signals by using PRR / ROR / MHRA / YuleQ and BCPNN methods. The system framework was designed with B / S / B / B browser / Server framework, and the reliability of the results was ensured by the detection method. In order to ensure the openness of the system and the diversity of users. Results: this study completed the establishment of the ADRCAS(Adverse DrugReactions Comprehensive Analysis system, and obtained the independent copyright for the system code from the National Edition Protection Center of China, and made use of the reporting and analysis function of the ADRCAS system. The comprehensive analysis of adverse reaction / event reporting can be completed. The analysis includes classification analysis by age, sex, dosage form, route of administration, outcome, drug type, location of adverse reaction, etc. By using the signal detection module of ADRCAS system, the intensity of ADR signal and its confidence interval can be detected by using five commonly used ADRs signal quantitative detection methods, and the ADRCAS system has been completed in Huangshan, Huaibei, Wuhu, Wuhu, Huangshan, Huaibei and Wuhu. The popularizing work of more than a dozen hospitals and drug administration departments in Hefei, Nanjing, Qingdao, and so on, and collected the ADR report data of nearly 30,000 cases in each region, and issued the system application account number to the corresponding area user. Conclusion: through practical application, the results show that ADRCAS system has strong practicability and good openness, which greatly improves the efficiency and accuracy of ADR analysis, systematizes the monitoring of ADRCAS signals and standardizes the methods. The results showed that the popularization of scientific .ADRCAS system in hospitals and drug management departments could improve the ability of pharmaceutical personnel to analyze adverse reactions and strengthen the detection of adverse drug reaction signals by pharmacists. Raise the level of drug vigilance in medical institutions and drug control agencies.
【學(xué)位授予單位】：皖南醫(yī)學(xué)院
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2014
【分類號】：R95

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