药品不良反应严重程度分级评价模型的建立与应用  

Establishment and application of a grading evaluation model for adverse drug reaction severity

作　　者：周雨婷 叶国菊[1] 刘尉[1] 王启明[1] 赵大方 孙骏[3] 李国亮 王新敏[3] ZHOU Yu-ting;YE Guo-ju;LIU Wei;WANG Qi-ming;ZHAO Da-fang;SUN Jun;LI Guo-liang;WANG Xin-min(College of Science,Hehai University,Jiangsu Nanjing 210098,China;School of Mathematics&Statistics,Hubei Normal University,Hubei Huangshi 435002,China;Jiangsu Center for Monitoring Adverse Drug Reactions,Jiangsu Nanjing 210002,China)

机构地区：[1]河海大学理学院,江苏南京210098 [2]湖北师范大学数学与统计学院,湖北黄石435002 [3]江苏省药品不良反应监测中心,江苏南京210002

出　　处：《中国医院药学杂志》2021年第20期2133-2137,共5页Chinese Journal of Hospital Pharmacy

基　　金：《江苏省药品不良反应信号检测及对药品生产安全风险的预警研究》(编号:KJ207559);江苏省自然科学基金项目(编号:BK20180500)。

摘　　要：目的:针对药品不良反应(adverse drug reaction,ADR)严重程度的评价问题,改进统计法,量化ADR的严重程度,建立新的ADR严重程度分级评价模型。方法:引入区间数学的相关理论,基于Hamming贴近度,提出了ADR严重度和ADR严重程度隶属度的概念,结合模糊综合评价法建立新的ADR严重程度分级评价模型。结果:根据新的ADR严重程度分级评价模型,多西他赛的不良反应严重程度为3级,紫杉醇注射液的不良反应严重程度在3级和4级间波动,多西他赛相对紫杉醇注射液严重程度低,严重程度波动相对稳定。结论:基于区间数学和模糊数学理论,变单纯计次为考虑多源信息的模糊计次,能更好地分析利用不良反应报告,并对ADR的严重程度进行量化研究和分级评价,确定ADR的严重程度等级,便于不同药品之间ADR严重程度的比较。OBJECTIVE To address the practical issue of evaluating the severity of adverse drug reaction(ADR)and establish a new grading evaluation model of ADR severity.METHODS The theory of interval mathematics was introduced.Based upon the Hamming osculating method,the concepts of ADR severity and membership were proposed.And a new model of ADR severity grading evaluation was established by fuzzy comprehensive evaluation.RESULTS According to the new grading evaluation model of ADR severity,the severity of adverse reactions of docetaxel was grade Ⅲ,the severity of adverse reactions of paclitaxel injection fluctuated between grades Ⅲ and Ⅳ,the severity of adverse reactions of docetaxel relative to paclitaxel injection was low and severity fluctuation was relatively stable.CONCLUSION Based upon interval mathematics and fuzzy mathematical theory,variation is counted as fuzzy counting frequency of multi-source information.It enables a better analysis and utilization of ADR reports.The severity of ADRs may be quantitatively evaluated and graded so as to facilitate the comparison of ADR severity between different drug products.

关 键 词：不良反应 ADR严重度 区间数 Hamming贴近度 分级评价 

分 类 号：R969.3[医药卫生—药理学]