药品不良反应综合分析系统ADRCAS的开发应用

中国临床药理学与治疗学 ›› 2014, Vol. 19 ›› Issue (6): 712-716.

药品不良反应综合分析系统^ADRCAS的开发应用

胡骅, 谢海棠, 徐喆, 濮之晨, 陈群, 孙华, 张雪峰

皖南医学院第一附属医院弋矶山医院临床药学部, 安徽省药物临床评价中心, 芜湖 241001, 安徽

收稿日期:2014-04-02 修回日期:2014-06-05 发布日期:2014-07-01
通讯作者: 谢海棠, 女, 博士, 研究员, 研究生导师, 研究方向:药物定量研究与评价。Tel: 0553-5738200 E-mail: xiehaitang@sina.com
作者简介:胡骅, 男, 硕士, 研究方向:定量药理学。Tel: 15955370063 E-mail: huhua_1028@sina.com
基金资助:
安徽省卫生厅医学科研重点项目[药物有效性及安全性量化评价体系及其关键性技术研究(2010A013)]

Development of ^ADRCAS ——adverse drug reactions comprehensive analysis system

HU Hua, XIE Hai-tang, XU Zhe, PU Zhi-cheng, CHEN Qun, SUN Hua, ZHANG Xue-feng

Institute of Clinical Pharmacology, Anhui Provincial Center for Drug Clinical Evaluation, Yijishan Hospital of Wannan Medical College, Wuhu 241001, Anhui, China

Received:2014-04-02 Revised:2014-06-05 Published:2014-07-01

摘要/Abstract

摘要： 目的: 建立药品不良反应综合分析系统(adverse drug reactions comprehensive analysis system, ^ADRCAS), 对繁杂的不良反应报告信息进行全面整理和系统分析, 自动生成不良反应分析结果。方法: ^ADRCAS在Windows环境下开发, 使用Java 1.6、 javascript、css和hmtl等语言编制, 并以Oracle为数据库和以Excel数据表为输出, 建立局域网或互联网开放式服务器, 用户可利用IE浏览器进行在线数据导入与分析。结果: 应用^ADRCAS报告分析功能, 对药品不良反应/事件报告(ADR/E)进行综合分析, 并应用五种国际通用不良反应信号定量检测方法检测出药品-不良反应记录的组合的信号强度以及其置信区间。结论: ^ADRCAS操作简便、实用性强、开放性好, 使药品不良反应分析方便易行, 使药品不良反应信号监测定量化、规范化、系统化。

关键词: 药品不良反应综合分析系统, 不良反应报告分析, 信号检测

Abstract: AIM : To develop comprehensive analysis of complex adverse reaction reports by establishing a comprehensive analysis of adverse drug reaction System (^ADRCAS), and automatically generating the results of adverse reaction reports.METHODS: ^ADRCAS was developed in Windows environment, using Java 1.6, JavaScript, css, and hmtl as programming language, using Oracle as database and Excel as output table. We can create a local area network or open Internet server, allowing users to take advantage of Internet Explorer for online data import and analysis.RESULTS:Through the application of analytic functions of software, we can complete comprehensive analysis of adverse reaction /event reporting (ADR/E) cases. Using five kinds of common adverse reactions quantitative signal detection function, we can detect the signal strength and the confidence interval of the drugs-adverse reactions recorded.CONCLUSION: ^ADRCAS is easy to operate, the practicality and the openness are good .It can make the analysis of adverse drug reaction more convenient, make the signal monitoring more quantitative, standardized and systematic.

Key words: adverse drug reactions comprehensive analysis system, adverse reaction reports analysis, signal detection

中图分类号:

R311

胡骅, 谢海棠, 徐喆, 濮之晨, 陈群, 孙华, 张雪峰. 药品不良反应综合分析系统^ADRCAS的开发应用[J]. 中国临床药理学与治疗学, 2014, 19(6): 712-716.

HU Hua, XIE Hai-tang, XU Zhe, PU Zhi-cheng, CHEN Qun, SUN Hua, ZHANG Xue-feng. Development of ^ADRCAS ——adverse drug reactions comprehensive analysis system[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2014, 19(6): 712-716.

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