药品不良反应因果关系的判断指标效率分析  

Analysis of efficiency of causality judgement indicators of adverse drug reactions

作　　者：黄登笑[1,2] 盛红彬[2] 黄淇敏[2] 

机构地区：[1]上海交通大学安泰经济管理学院,上海200052 [2]上海交通大学医学院附属第三人民医院医务部,上海201900

出　　处：《上海交通大学学报（医学版）》2010年第11期1416-1419,共4页Journal of Shanghai Jiao tong University:Medical Science

基　　金：上海市宝山区科委基金(08-E-2);上海市教委基金(09YS109)~~

摘　　要：目的分析药品不良反应(ADR)因果关系判断指标的效率。方法采用文献检索法收集ADR因果关系判断指标,通过专家座谈法综合确定14项指标或因子(反应时间、停药症状、再次用药、同类报道、其他证据、类似反应、剂量变化、血药浓度、安慰剂、合并用药、家庭史、既往史、基础疾病和非药物因素)为ADR因果关系判断效率的关键指标,并制作调查问卷。对65名上海市食品药品监督管理局和各级医疗相关单位专业ADR损害因果判断人员进行问卷调查,回收有效问卷61份,有效率94%。对问卷调查结果进行因子分析,通过计算各指标方差,判断各指标在因果判断中的作用;运用降维技术探讨ADR因果关系判断的最小因子数。结果 Kaiser-Meyer-Olkin和Bartlett检验显示,各指标之间存在一定的相关性;降维到7项因子时,判断效率≥85%;用得分函数表示7项因子(既往相关因子、信息佐证因子、停药反应因子、血药浓度因子、时间因子、对照因子和相似病例因子)间的关系;如果以降维的7项因子进行判断,约有15%的信息未被纳入,容易造成判断误差,尤其在个体信息较少时对个体因果关系判断可能出现失误。结论在建立ADR补偿制度过程中,对个体损害因果的判断需要纳入更多的指标以提高判断效率,体现社会公平性。Objective To analyse the efficiency of causality judgement indicators of adverse drug reactions （ADR）.MethodsCausality judgement indicators of ADR were collected by literature review,14 indicators （reaction time,withdrawl symptom,a second drug application,similar report,another evidence,similar response,dose change,plasma drug concentration,placebo,combined medication,family history,past history,baseline disease and non-drug factor） were determined as key indicators for efficiency of causality judgement of ADR by expert interview,and questionnaires were designed.Sixty-five staff from Shanghai Food and Drug Administration and medical units were surveyed,and 61 （94%） effective questionnaires were recovered.Factor analysis was conducted on the basis survey findings,and the role of each indicator in causality judgement was obtained by variance calculation.The minimum number of causality judgement indicators of ADR was determined by dimension reduction method.Results Kaiser-Meyer-Olkin and Bartlett tests revealed that there existed relevance among various indicators.When the number of indicators reduced to 7,the efficiency was ≥85%.The relationship among 7 indicators （past related indicator,information evidence indicator,withdrawl reaction indicator,plasma drug concentration indicator,time indicator,control indicator and similar case indicator） were illustrated by score function.Judged by 7 indicators,nearly 15% information was not included,and might lead to false judgement.Conclusion More factors should be included in the causality judgement of ADR in the establishment of compensation system for ADR to ensure social justice.

关 键 词：药品不良反应 因果关系 效率 

分 类 号：R95[医药卫生—药学]