药品不良反应损害程度评分标准的制定及应用  

Development of the rating standards for the evaluation of damage caused by adverse drug reactions

作　　者：许佼[1,2] 龚建军[3] 王卓[1] 沈洪清 张永玲[2] 

机构地区：[1]第二军医大学长海医院药学部,上海200433 [2]安徽省宿州市食品药品监督管理局药品安全监管科,宿州234000 [3]南京军区鼓浪屿疗养院药剂科,厦门361002 [4]安徽省宿州市药品不良反应监测中心,宿州234000

出　　处：《药学服务与研究》2013年第2期93-97,共5页Pharmaceutical Care and Research

摘　　要：目的:制定药品不良反应(ADRs)损害程度评分标准,并应用其对日常ADRs报告进行评分和分析,以对该评分标准进行验证和评价。方法:问卷咨询48位医药卫生专家,对ADRs损害程度进行独立评分和序化分级,制定新的ADRs损害程度评分标准;运用该标准对23 959个ADRs报告进行评分并对结果进行分析。结果:按现行网上自愿呈报系统分类方法,一般级占89.62%,新的ADRs占8.87%,严重级占1.51%。按本研究新制定的标准评分,ADRs损害程度分为11级,从轻至重分别为9～98分。按药理学分类:以报告频率排序,β-内酰胺类抗生素以3 469个居首;以ADRs严重度指数(severity indexof ADRs,SIADR)值排序,抗肿瘤药物及抗肿瘤辅助药物以33.4分居首。按药品通用名分类:以ADRs报告频率排序,左氧氟沙星注射剂以1 000个为第一位;以SIADR值排序,癸氟奋乃静注射剂以44.5分列第一。结论:本研究制定的ADRs损害程度评分法具有细化、量化、可加和,及便于比较的特点,在ADRs损害程度的个例分析和集中分析中均可行,值得进一步研究。Objective： To develop the rating standards for the evaluation of damage caused by adverse drug reactions（ADRs） and use them to rate and analyze daily ADRs reports for final demonstration and evaluation of the rating standards.Methods： Forty-eight medical and health experts were consulted through questionnaires,and independent scoring and sequential grading were made on the damage caused by ADRs,then new rating standards were developed for the evaluation of the damage caused by ADRs,and finally,scoring was made on 23 959 ADSs reports by using the new rating standards and the obtained results were analyzed statistically.Results： By the standards of spontaneous ADRs reporting system,general ADRs accounted for 89.62%,new ADRs accounted for 8.87% and severe ADRs for 1.51%.By the standards developed through this study,the severity of ADRs was divided into 11 grades,with scores of 9 to 98,from mild to severe.In accordance with pharmacological classification,β-lactam antibiotics ranked the first with 3 469 cases in the ADRs reports.In sequential order of severity index of ADRs（SIADR）,anti-tumor drugs and anti-tumor adjuvant drugs ranked the first with a score of 33.4.In accordance with the frequency order of ADRs reports by using the international nonproprietary names of drugs,ADRs of levofloxacin injection were the most frequently reported（1 000 cases）,and when in sequence order,decanoate fluphenazine injection ranked the first with a score of 44.5.Conclusion： The new standards for the rating and scoring of ADRs make the evaluation of ADRs severity more concrete,quantitative and additive,and are suitable for use in ADRs damage evaluation of individual and collective cases,and for this reason are worth further study.

关 键 词：药物副反应报告系统 严重度指数 评分标准 

分 类 号：R994.11[医药卫生—毒理学]