药物不良反应综合分析系统的开发与应用

发布时间：2018-02-15 21:11

本文关键词： 药品不良反应/不良事件药品不良反应综合分析系统药品不良反应报告分析药品不良反应信号检测　出处：《皖南医学院》2014年硕士论文　论文类型：学位论文

【摘要】：目的：药品不良反应（adverse drug reaction，ADR）的监测及分析工作是药品上市后研究的重要内容，我国对ADR的监测工作现主要是通过自发呈报系统(spontaneous reporting system，，SRS)来完成的，在该系统的应用过程中，出现了比如数据信息堆积、数据分类困难、数据信息不标准等问题，这些都使得药品不良反应/不良事件（adverse drug event，ADE）分析工作难以展开。需要有更智能化，便于操作的分析工具进行不良反应/事件报告分析。本研究计划编制一个能进行ADR报告数据标准化处理、不良反应/事件报告综合分析、不良反应累及系统或器官分类分析及药品不良反应信号（Signal）挖掘为主要功能的开放性综合评价系统，并将其推广到各级药学相关人员，从而实现不良反应/事件报告数据分析和药品不良反应信号检测的自动化、应用的开放化、数据的共享化。方法：该系统在Windows7的开发环境下，使用Java1.6， css，和hmtl语言编制，并以Oracle11为数据库和以Excel数据表为输出，可建立局域网或互联网开放式平台，用户借助IE浏览器即可进行在线数据导入及分析。系统运用国内外文献常用的的不良反应/事件报告（ADR/E）例次分析方式进行综合分析，并运用药品不良反应信号定量检测的5种方法（PRR法、ROR法、MHRA法、YuleQ值法和BCPNN法）对不良反应信号进行检测，检测方法全面保证结果的可靠性。系统框架选用B/S（Browser/Server）构架，以保证系统的开放性和用户的多元性。结果：本研究完成了药物不良反应综合分析系统即ADRCAS（Adverse DrugReactions Comprehensive Analysis System）系统的建立工作，并为系统代码向中国国家版保护中心申请获得了独立著作权；利用ADRCAS系统报告分析功能，可以完成不良反应/事件报例次的综合分析，分析内容包括按年龄、性别、剂型、给药途径、转归情况、药品类别、不良反应发生部位等进行的分类分析，并快速得到分析表格；利用ADRCAS系统信号检测模块，可使用5种常用不良反应信号定量检测方法检测出药品不良反应信号强度以及其置信区间；ADRCAS系统完成了在黄山、淮北、芜湖、合肥、南京、青岛等地区的十几家医院和药监管理部门的推广工作，并总计收集到近3万例各个地区的ADR报告数据，并对相应地区用户发布了系统应用帐号。结论：经过实际应用，结果表明，ADRCAS系统实用性较强，开放性好，在很大程度上提高了药品不良反应分析的效率和准确性，使不良反应信号监测系统化、方法规范化、指标定量化、结果科学化。ADRCAS系统在医院及药管部门内的推广，可以提高药学人员对不良反应的分析能力，强化药学人员对药品不良反应信号的检测，提高医疗机构以及药品管理机构的药物警戒水平。
[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.
【学位授予单位】：皖南医学院
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：R95

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